699 results on '"Moy, Beverly"'
Search Results
2. Systemic Treatment of Patients With Metastatic Breast Cancer: ASCO Resource-Stratified Guideline.
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Al Sukhun, Sana, Temin, Sarah, Barrios, Carlos, Antone, Nicoleta, Guerra, Yanin, Mac Gregor, Mariana, Chopra, Rakesh, Danso, Michael, Gomez, Henry, Homian, NDa, Kandil, Alaa, Kithaka, Benda, Koczwara, Bogda, Moy, Beverly, Nakigudde, Gertrude, Petracci, Fernando, Rugo, Hope, El Saghir, Nagi, and Arun, Banu
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Humans ,B7-H1 Antigen ,BRCA1 Protein ,BRCA2 Protein ,Trastuzumab ,Triple Negative Breast Neoplasms ,Hormones - Abstract
PURPOSE: To guide clinicians and policymakers in three global resource-constrained settings on treating patients with metastatic breast cancer (MBC) when Maximal setting-guideline recommended treatment is unavailable. METHODS: A multidisciplinary, multinational panel reviewed existing ASCO guidelines and conducted modified ADAPTE and formal consensus processes. RESULTS: Four published resource-agnostic guidelines were adapted for resource-constrained settings; informing two rounds of formal consensus; recommendations received ≥75% agreement. RECOMMENDATIONS: Clinicians should recommend treatment according to menopausal status, pathological and biomarker features when quality results are available. In first-line, for hormone receptor (HR)-positive MBC, when a non-steroidal aromatase inhibitor and CDK 4/6 inhibitor combination is unavailable, use hormonal therapy alone. For life-threatening disease, use single-agent chemotherapy or surgery for local control. For premenopausal patients, use ovarian suppression or ablation plus hormone therapy in Basic settings. For human epidermal growth factor receptor 2 (HER2)-positive MBC, if trastuzumab, pertuzumab, and chemotherapy are unavailable, use trastuzumab and chemotherapy; if unavailable, use chemotherapy. For HER2-positive, HR-positive MBC, use standard first-line therapy, or endocrine therapy if contraindications. For triple-negative MBC with unknown PD-L1 status, or if PD-L1-positive and immunotherapy unavailable, use single-agent chemotherapy. For germline BRCA1/2 mutation-positive MBC, if poly(ADP-ribose) polymerase inhibitor is unavailable, use hormonal therapy (HR-positive MBC) and chemotherapy (HR-negative MBC). In second-line, for HR-positive MBC, Enhanced setting recommendations depend on prior treatment; for Limited, use tamoxifen or chemotherapy. For HER2-positive MBC, if trastuzumab deruxtecan is unavailable, use trastuzumab emtansine; if unavailable, capecitabine and lapatinib; if unavailable, trastuzumab and/or chemotherapy (hormonal therapy alone for HR-positive MBC).Additional information is available at www.asco.org/resource-stratified-guidelines. It is ASCOs view that healthcare providers and system decision-makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement but not replace local guidelines.
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- 2024
3. Community Collaboration to Advance Racial/Ethnic Equity in Colorectal Cancer Screening: Protocol for a Multilevel Intervention to Improve Screening and Follow-up in Community Health Centers
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May, Folasade P., Brodney, Suzanne, Tuan, Jessica J., Syngal, Sapna, Chan, Andrew T., Glenn, Beth, Johnson, Gina, Chang, Yuchiao, Drew, David A., Moy, Beverly, Rodriguez, Nicolette J., Warner, Erica T., Anyane-Yeboa, Adjoa, Ukaegbu, Chinedu, Davis, Anjelica Q., Schoolcraft, Kimberly, Regan, Susan, Yoguez, Nathan, Kuney, Samantha, Le Beaux, Kelley, Jeffries, Catherine, Lee, Ellen T., Bhat, Roopa, and Haas, Jennifer S.
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- 2024
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4. Utilizing cell-free DNA to predict risk of developing brain metastases in patients with metastatic breast cancer
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Vidula, Neelima, Niemierko, Andrzej, Hesler, Katherine, Ryan, Lianne, Moy, Beverly, Isakoff, Steven, Ellisen, Leif, Juric, Dejan, and Bardia, Aditya
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- 2023
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5. Feasibility of introducing a smartphone navigation application into the care of breast cancer patients (The FIONA Study)
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Isakoff, Steven J., Said, Maya R., Kwak, Agnes H., Glieberman, Eva, O’Rourke, Emily A., Stroiney, Amanda, Spring, Laura M., Moy, Beverly, Bardia, Aditya, Horick, Nora, and Peppercorn, Jeffrey M.
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- 2023
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6. Biomarker Analysis of the Phase III NALA Study of Neratinib + Capecitabine versus Lapatinib + Capecitabine in Patients with Previously Treated Metastatic Breast CancerBiomarker Analysis of the Phase III NALA Study in HER2+ MBC
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Saura, Cristina, Matito, Judit, Oliveira, Mafalda, Wildiers, Hans, Brufksy, Adam M, Waters, Simon H, Hurvitz, Sara A, Moy, Beverly, Kim, Sung-Bae, Gradishar, William J, Queiroz, Geraldo Silva, Cronemberger, Eduardo, Wallweber, Gerald J, Bebchuk, Judith, Keyvanjah, Kiana, Lalani, Alshad S, Bryce, Richard, Vivancos, Ana, Eli, Lisa D, and Delaloge, Suzette
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Breast Cancer ,Cancer ,Detection ,screening and diagnosis ,4.2 Evaluation of markers and technologies ,Antineoplastic Combined Chemotherapy Protocols ,Biomarkers ,Tumor ,Breast Neoplasms ,Capecitabine ,Correlation of Data ,Female ,Humans ,Lapatinib ,Neoplasm Metastasis ,Quinolines ,Retreatment ,Oncology and Carcinogenesis ,Oncology & Carcinogenesis - Abstract
PurposeNeratinib plus capecitabine (N+C) demonstrated significant progression-free survival (PFS) benefit in NALA (NCT01808573), a randomized phase III trial comparing N+C with lapatinib + capecitabine (L+C) in 621 patients with HER2-positive (HER2+) metastatic breast cancer (MBC) who had received ≥2 prior HER2-directed regimens in the metastatic setting. We evaluated correlations between exploratory biomarkers and PFS.Patients and methodsSomatic mutations were evaluated by next-generation sequencing on primary or metastatic samples. HER2 protein expression was evaluated by central IHC, H-score, and VeraTag/HERmark. p95 expression (truncated HER2) was measured by VeraTag. HRs were estimated using unstratified Cox proportional hazards models.ResultsFour hundred and twenty samples had successful sequencing: 34.0% had PIK3CA mutations and 5.5% had HER2 (ERBB2) mutations. In the combined patient populations, PIK3CA mutations trended toward shorter PFS [wild-type vs. mutant, HR = 0.81; 95% confidence interval (CI), 0.64-1.03], whereas HER2 mutations trended toward longer PFS [HR = 1.69 (95% CI, 0.97-3.29)]. Higher HER2 protein expression was associated with longer PFS [IHC 3+ vs. 2+, HR = 0.67 (0.54-0.82); H-score ≥240 versus
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- 2021
7. Efficacy of Neratinib Plus Capecitabine in the Subgroup of Patients with Central Nervous System Involvement from the NALA Trial
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Hurvitz, Sara A, Saura, Cristina, Oliveira, Mafalda, Trudeau, Maureen E, Moy, Beverly, Delaloge, Suzette, Gradishar, William, Kim, Sung‐Bae, Haley, Barbara, Ryvo, Larisa, Dai, Ming‐Shen, Milovanov, Vladimir, Alarcón, Jesús, Kalmadi, Sujith, Cronemberger, Eduardo, Souza, Cristiano, Landeiro, Luciana, Bose, Ron, Bebchuk, Judith, Kabbinavar, Fairooz, Bryce, Richard, Keyvanjah, Kiana, and Brufsky, Adam M
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Biomedical and Clinical Sciences ,Oncology and Carcinogenesis ,Cancer ,Breast Cancer ,Brain Disorders ,Neurosciences ,Clinical Trials and Supportive Activities ,Clinical Research ,Comparative Effectiveness Research ,Prevention ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Antineoplastic Combined Chemotherapy Protocols ,Breast Neoplasms ,Capecitabine ,Central Nervous System ,Female ,Humans ,Quinolines ,Receptor ,ErbB-2 ,Treatment Outcome ,Central nervous system neoplasms ,Lapatinib ,Neratinib ,Receptor ,ErbB-2 ,Receptor ,erbB-2 ,Oncology & Carcinogenesis ,Oncology and carcinogenesis - Abstract
BackgroundNeratinib has efficacy in central nervous system (CNS) metastases from HER2-positive metastatic breast cancer (MBC). We report outcomes among patients with CNS metastases at baseline from the phase III NALA trial of neratinib plus capecitabine (N + C) versus lapatinib plus capecitabine (L + C).Materials and methodsNALA was a randomized, active-controlled trial in patients who received two or more previous HER2-directed regimens for HER2-positive MBC. Patients with asymptomatic/stable brain metastases (treated or untreated) were eligible. Patients were assigned to N + C (neratinib 240 mg per day, capecitabine 750 mg/m2 twice daily) or L + C (lapatinib 1,250 mg per day, capecitabine 1,000 mg/m2 twice daily) orally. Independently adjudicated progression-free survival (PFS), overall survival (OS), and CNS endpoints were considered.ResultsOf 621 patients enrolled, 101 (16.3%) had known CNS metastases at baseline (N + C, n = 51; L + C, n = 50); 81 had received prior CNS-directed radiotherapy and/or surgery. In the CNS subgroup, mean PFS through 24 months was 7.8 months with N + C versus 5.5 months with L + C (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.41-1.05), and mean OS through 48 months was 16.4 versus 15.4 months (HR, 0.90; 95% CI, 0.59-1.38). At 12 months, cumulative incidence of interventions for CNS disease was 25.5% for N + C versus 36.0% for L + C, and cumulative incidence of progressive CNS disease was 26.2% versus 41.6%, respectively. In patients with target CNS lesions at baseline (n = 32), confirmed intracranial objective response rates were 26.3% and 15.4%, respectively. No new safety signals were observed.ConclusionThese analyses suggest improved PFS and CNS outcomes with N + C versus L + C in patients with CNS metastases from HER2-positive MBC.Implications for practiceIn a subgroup of patients with central nervous system (CNS) metastases from HER2-positive breast cancer after two or more previous HER2-directed regimens, the combination of neratinib plus capecitabine was associated with improved progression-free survival and CNS outcomes compared with lapatinib plus capecitabine. These findings build on previous phase II and III studies describing efficacy of neratinib in the prevention and treatment of CNS metastases, and support a role for neratinib as a systemic treatment option in the management of patients with HER2-positive brain metastases following antibody-based HER2-directed therapies.
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- 2021
8. Neratinib + capecitabine sustains health-related quality of life in patients with HER2-positive metastatic breast cancer and ≥ 2 prior HER2-directed regimens
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Moy, Beverly, Oliveira, Mafalda, Saura, Cristina, Gradishar, William, Kim, Sung-Bae, Brufsky, Adam, Hurvitz, Sara A, Ryvo, Larisa, Fagnani, Daniele, Kalmadi, Sujith, Silverman, Paula, Delaloge, Suzette, Alarcon, Jesus, Kwong, Ava, Lee, Keun Seok, Ang, Peter Cher Siang, Ow, Samuel Guan Wei, Chu, Sung-Chao, Bryce, Richard, Keyvanjah, Kiana, Bebchuk, Judith, Zhang, Bo, Oestreicher, Nina, Bose, Ron, and Chan, Nancy
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Biomedical and Clinical Sciences ,Oncology and Carcinogenesis ,Breast Cancer ,Cancer ,Clinical Trials and Supportive Activities ,Clinical Research ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Antineoplastic Combined Chemotherapy Protocols ,Breast Neoplasms ,Capecitabine ,Female ,Humans ,Quality of Life ,Quinolines ,Receptor ,ErbB-2 ,Neratinib ,Metastatic breast cancer ,Health-related quality of life ,HER2-positive ,Receptor ,erbB-2 ,Clinical Sciences ,Oncology & Carcinogenesis ,Clinical sciences ,Oncology and carcinogenesis - Abstract
PurposeTo characterize health-related quality of life (HRQoL) in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) from the NALA phase 3 study.MethodsIn NALA (NCT01808573), patients were randomized 1:1 to neratinib + capecitabine (N + C) or lapatinib + capecitabine (L + C). HRQoL was assessed using seven prespecified scores from the European Organisation for Research and Treatment of Cancer Quality Of Life Questionnaire core module (QLQ-C30) and breast cancer-specific questionnaire (QLQ-BR23) at baseline and every 6 weeks. Descriptive statistics summarized scores over time, mixed models evaluated differences between treatment arms, and Kaplan-Meier methods were used to assess time to deterioration in HRQoL scores of ≥ 10 points.ResultsOf the 621 patients randomized in NALA, patients were included in the HRQoL analysis if they completed baseline and at least one follow-up questionnaire. The summary, global health status, physical functioning, fatigue, constipation, and systemic therapy side effects scores were stable over time with no persistent differences between treatment groups. There were no differences in time to deterioration (TTD) for the QLQ-C30 summary score between treatment arms; the hazard ratio (HR) for N + C vs. L + C was 0.94 (95% CI 0.63-1.40). Only the diarrhea score worsened significantly more in the N + C arm as compared to the L + C arm, and this remained over time (HR for TTD for N + C vs. L + C was 1.71 [95% CI 1.32-2.23]).ConclusionIn NALA, patients treated with N + C maintained their global HRQoL over time, despite a worsening of the diarrhea-related scores. These results may help guide optimal treatment selection for HER2-positive MBC.
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- 2021
9. Circulating Tumor DNA in Breast Cancer: Current and Future Applications
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Medford, Arielle J., Denault, Elyssa N., Moy, Beverly, Parsons, Heather A., and Bardia, Aditya
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- 2023
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10. Breast cancer polygenic risk scores are associated with short-term risk of poor prognosis breast cancer
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McCarthy, Anne Marie, Manning, Alisa K., Hsu, Sarah, Welch, Michaela, Moy, Beverly, Lehman, Constance D., and Armstrong, Katrina
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- 2022
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11. Overall survival with neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): A randomised, double-blind, placebo-controlled, phase 3 trial
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Holmes, Frankie A., Moy, Beverly, Delaloge, Suzette, Chia, Stephen K.L., Ejlertsen, Bent, Mansi, Janine, Iwata, Hiroji, Gnant, Michael, Buyse, Marc, Barrios, Carlos H., Silovski, Tajana, Šeparović, Robert, Bashford, Anna, Zotano, Angel Guerrero, Denduluri, Neelima, Patt, Debra, Gokmen, Erhan, Gore, Ira, Smith, John W., II, Loibl, Sibylle, Masuda, Norikazu, Tomašević, Zorica, Petráková, Katarina, DiPrimeo, Daniel, Wong, Alvin, Martin, Miguel, and Chan, Arlene
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- 2023
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12. Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer Previously Treated With ≥ 2 HER2-Directed Regimens: Phase III NALA Trial
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Saura, Cristina, Oliveira, Mafalda, Feng, Yin-Hsun, Dai, Ming-Shen, Chen, Shang-Wen, Hurvitz, Sara A, Kim, Sung-Bae, Moy, Beverly, Delaloge, Suzette, Gradishar, William, Masuda, Norikazu, Palacova, Marketa, Trudeau, Maureen E, Mattson, Johanna, Yap, Yoon Sim, Hou, Ming-Feng, De Laurentiis, Michelino, Yeh, Yu-Min, Chang, Hong-Tai, Yau, Thomas, Wildiers, Hans, Haley, Barbara, Fagnani, Daniele, Lu, Yen-Shen, Crown, John, Lin, Johnson, Takahashi, Masato, Takano, Toshimi, Yamaguchi, Miki, Fujii, Takaaki, Yao, Bin, Bebchuk, Judith, Keyvanjah, Kiana, Bryce, Richard, and Brufsky, Adam
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Biomedical and Clinical Sciences ,Oncology and Carcinogenesis ,Breast Cancer ,Prevention ,Clinical Research ,Cancer ,Clinical Trials and Supportive Activities ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Aged ,Antineoplastic Combined Chemotherapy Protocols ,Brain Neoplasms ,Breast Neoplasms ,Breast Neoplasms ,Male ,Capecitabine ,Diarrhea ,Female ,Humans ,Kaplan-Meier Estimate ,Lapatinib ,Male ,Middle Aged ,Nausea ,Progression-Free Survival ,Quality of Life ,Quinolines ,Receptor ,ErbB-2 ,Retreatment ,Survival Rate ,NALA Investigators ,Receptor ,erbB-2 ,Clinical Sciences ,Oncology & Carcinogenesis ,Oncology and carcinogenesis - Abstract
PurposeNALA (ClinicalTrials.gov identifier: NCT01808573) is a randomized, active-controlled, phase III trial comparing neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), plus capecitabine (N+C) against lapatinib, a reversible dual TKI, plus capecitabine (L+C) in patients with centrally confirmed HER2-positive, metastatic breast cancer (MBC) with ≥ 2 previous HER2-directed MBC regimens.MethodsPatients, including those with stable, asymptomatic CNS disease, were randomly assigned 1:1 to neratinib (240 mg once every day) plus capecitabine (750 mg/m2 twice a day 14 d/21 d) with loperamide prophylaxis, or to lapatinib (1,250 mg once every day) plus capecitabine (1,000 mg/m2 twice a day 14 d/21 d). Coprimary end points were centrally confirmed progression-free survival (PFS) and overall survival (OS). NALA was considered positive if either primary end point was met (α split between end points). Secondary end points were time to CNS disease intervention, investigator-assessed PFS, objective response rate (ORR), duration of response (DoR), clinical benefit rate, safety, and health-related quality of life (HRQoL).ResultsA total of 621 patients from 28 countries were randomly assigned (N+C, n = 307; L+C, n = 314). Centrally reviewed PFS was improved with N+C (hazard ratio [HR], 0.76; 95% CI, 0.63 to 0.93; stratified log-rank P = .0059). The OS HR was 0.88 (95% CI, 0.72 to 1.07; P = .2098). Fewer interventions for CNS disease occurred with N+C versus L+C (cumulative incidence, 22.8% v 29.2%; P = .043). ORRs were N+C 32.8% (95% CI, 27.1 to 38.9) and L+C 26.7% (95% CI, 21.5 to 32.4; P = .1201); median DoR was 8.5 versus 5.6 months, respectively (HR, 0.50; 95% CI, 0.33 to 0.74; P = .0004). The most common all-grade adverse events were diarrhea (N+C 83% v L+C 66%) and nausea (53% v 42%). Discontinuation rates and HRQoL were similar between groups.ConclusionN+C significantly improved PFS and time to intervention for CNS disease versus L+C. No new N+C safety signals were observed.
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- 2020
13. Outcomes after treatment of breast cancer during pregnancy including taxanes and/or granulocyte colony-stimulating factor use: findings from a multi-institutional retrospective analysis
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Sella, Tal, Exman, Pedro, Ren, Siyang, Freret, Taylor S., Economy, Katherine E., Chen, Wendy Y., Parsons, Heather A., Lin, Nancy U., Moy, Beverly, Tung, Nadine M., Partridge, Ann H., Tayob, Nabihah, and Mayer, Erica L.
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- 2022
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14. Sequential combination of sacituzumab govitecan and talazoparib in metastatic triple negative breast cancer (mTNBC): Results from a phase II study.
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Abelman, Rachel Occhiogrosso, primary, Spring, Laura, additional, Niemierko, Andrzej, additional, Abraham, Elizabeth, additional, McNeice, Mary, additional, Goff, Jennifer, additional, Valenti, Amanda, additional, Wander, Seth Andrew, additional, Isakoff, Steven J., additional, Moy, Beverly, additional, Juric, Dejan, additional, Vidula, Neelima, additional, Waks, Adrienne Gropper, additional, Parsons, Heather Anne, additional, Ellisen, Leif W., additional, Tolaney, Sara M., additional, and Bardia, Aditya, additional
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- 2024
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15. Pilot study to assess prolonged overnight fasting in breast cancer survivors (longfast)
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O’Donnell, Elizabeth, Shapiro, Yael, Comander, Amy, Isakoff, Steven, Moy, Beverly, Spring, Laura, Wander, Seth, Kuter, Irene, Shin, Jennifer, Specht, Michelle, Kournioti, Chryssanthi, Hu, Bonnie, Sullivan, Carol, Winters, Loren, Horick, Nora, and Peppercorn, Jeffrey
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- 2022
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16. Residual Disease Burden After Neoadjuvant Therapy Among US Patients With High-Risk HER2-positive Early-Stage Breast Cancer: A Population Effectiveness Model
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Hendrix, Nathaniel, Oestreicher, Nina, Lalla, Deepa, Dolan, Chantal M., Fisher, Kathryn A., Veenstra, David L., and Moy, Beverly
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- 2022
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17. Impact of Timing on Measurement of Decision Quality and Shared Decision Making: Longitudinal Cohort Study of Breast Cancer Patients.
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Sepucha, Karen, Langford, Aisha, Belkora, Jeffrey, Chang, Yuchiao, Moy, Beverly, Partridge, Ann, and Lee, Clara
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bias ,breast neoplasms ,choice behavior ,decision making ,goals ,mastectomy ,questionnaires ,segmental ,surveys ,Adult ,Breast Neoplasms ,Choice Behavior ,Cohort Studies ,Decision Making ,Shared ,Female ,Humans ,Longitudinal Studies ,Middle Aged ,Surveys and Questionnaires ,Time Factors - Abstract
Purpose.The objective of this study was to examine whether scores of shared decision-making measures differ when collected shortly after (1 month) or long after (1 year) breast cancer surgical treatment decisions. Methods. Longitudinal, multisite survey of breast cancer (BC) patients, with measurements at 1 month and 1 year after surgery at 4 cancer centers. Patients completed the BC Surgery Decision Quality Instrument (used to generate a knowledge score, ratings of goals, and concordance with treatment preferences) and Shared Decision Making (SDM) Process survey at both time points. We tested several hypotheses related to the scores over time, including whether the scores discriminated between sites that did and did not offer formal decision support services. Exploratory analyses examined factors associated with large increases and decreases in scores over time. Results. Across the 4 sites, 229 patients completed both assessments. The mean total knowledge scores (69.2% [SD 16.6%] at 1 month and 69.4% [SD 17.7%] at 1 year, P = 0.86), SDM Process scores (2.7 [SD 1.1] 1 month v. 2.7 [SD 1.2] 1 year, P = 0.68), and the percentage of patients receiving their preferred treatment (92% at 1 month and 92% at 1 year, P = 1.0) were not significantly different over time. The site using formal decision support had significantly higher knowledge and SDM Process scores at 1 month, and only the SDM Process scores remained significantly higher at 1 year. A significant percentage of patients had large changes in their individual knowledge and SDM Process scores, with increases balancing out decreases. Conclusion. For population-level assessments, it is reasonable to survey BC patients up to a year after the decision, greatly increasing feasibility of measurement. For those evaluating decision support interventions, shorter follow-up is more likely to detect an impact on knowledge scores.
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- 2019
18. Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer
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Tolaney, Sara M, Guo, Hao, Pernas, Sonia, Barry, William T, Dillon, Deborah A, Ritterhouse, Lauren, Schneider, Bryan P, Shen, Fei, Fuhrman, Kit, Baltay, Michele, Dang, Chau T, Yardley, Denise A, Moy, Beverly, Marcom, P Kelly, Albain, Kathy S, Rugo, Hope S, Ellis, Mathew J, Shapira, Iuliana, Wolff, Antonio C, Carey, Lisa A, Overmoyer, Beth, Partridge, Ann H, Hudis, Clifford A, Krop, Ian E, Burstein, Harold J, and Winer, Eric P
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Biomedical and Clinical Sciences ,Clinical Sciences ,Oncology and Carcinogenesis ,Breast Cancer ,Clinical Trials and Supportive Activities ,Cancer ,Clinical Research ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Adult ,Aged ,Aged ,80 and over ,Breast Neoplasms ,Breast Neoplasms ,Male ,Chemotherapy ,Adjuvant ,Disease-Free Survival ,Female ,Follow-Up Studies ,Gene Expression Regulation ,Neoplastic ,Genetic Predisposition to Disease ,Genotype ,Humans ,Lymph Nodes ,Male ,Middle Aged ,Paclitaxel ,Peripheral Nervous System Diseases ,Poisson Distribution ,Polymorphism ,Single Nucleotide ,Receptor ,ErbB-2 ,Recurrence ,Risk ,Trastuzumab ,Treatment Outcome ,Receptor ,erbB-2 ,Oncology & Carcinogenesis ,Oncology and carcinogenesis - Abstract
PURPOSE:The Adjuvant Paclitaxel and Trastuzumab trial was designed to address treatment of patients with small human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The primary analysis of the Adjuvant Paclitaxel and Trastuzumab trial demonstrated a 3-year disease-free survival (DFS) of 98.7%. In this planned secondary analysis, we report longer-term outcomes and exploratory results to characterize the biology of small HER2-positive tumors and genetic factors that may predispose to paclitaxel-induced peripheral neuropathy (TIPN). PATIENTS AND METHODS:In this phase II study, patients with HER2-positive breast cancer with tumors 3 cm or smaller and negative nodes received paclitaxel (80 mg/m2) with trastuzumab for 12 weeks, followed by trastuzumab for 9 months. The primary end point was DFS. Recurrence-free interval (RFI), breast cancer-specific survival, and overall survival (OS) were also analyzed. In an exploratory analysis, intrinsic subtyping by PAM50 (Prosigna) and calculation of the risk of recurrence score were performed on the nCounter analysis system on archival tissue. Genotyping was performed to investigate TIPN. RESULTS:A total of 410 patients were enrolled from October 2007 to September 2010. After a median follow-up of 6.5 years, there were 23 DFS events. The 7-year DFS was 93% (95% CI, 90.4 to 96.2) with four (1.0%) distant recurrences, 7-year OS was 95% (95% CI, 92.4 to 97.7), and 7-year RFI was 97.5% (95% CI, 95.9 to 99.1). PAM50 analyses (n = 278) showed that most tumors were HER2-enriched (66%), followed by luminal B (14%), luminal A (13%), and basal-like (8%). Genotyping (n = 230) identified one single-nucleotide polymorphism, rs3012437, associated with an increased risk of TIPN in patients with grade 2 or greater TIPN (10.4%). CONCLUSION:With longer follow-up, adjuvant paclitaxel and trastuzumab is associated with excellent long-term outcomes. Distribution of PAM50 intrinsic subtypes in small HER2-positive tumors is similar to that previously reported for larger tumors.
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- 2019
19. Local–regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial)
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Bellon, Jennifer R, Guo, Hao, Barry, William T, Dang, Chau T, Yardley, Denise A, Moy, Beverly, Marcom, P Kelly, Albain, Kathy S, Rugo, Hope S, Ellis, Matthew, Wolff, Antonio C, Carey, Lisa A, Overmoyer, Beth A, Partridge, Ann H, Hudis, Clifford A, Krop, Ian, Burstein, Harold J, Winer, Eric P, and Tolaney, Sara M
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Biomedical and Clinical Sciences ,Clinical Sciences ,Oncology and Carcinogenesis ,Breast Cancer ,Cancer ,Clinical Research ,Clinical Trials and Supportive Activities ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Adult ,Aged ,Aged ,80 and over ,Breast Neoplasms ,Chemotherapy ,Adjuvant ,Female ,Humans ,Lymphatic Metastasis ,Mastectomy ,Segmental ,Middle Aged ,Neoplasm Recurrence ,Local ,Neoplasm Staging ,Paclitaxel ,Prospective Studies ,Radiotherapy ,Adjuvant ,Receptor ,ErbB-2 ,Survival Analysis ,Trastuzumab ,Treatment Outcome ,HER2 ,Stage I ,Local regional recurrence ,Breast cancer ,Receptor ,erbB-2 ,Oncology & Carcinogenesis ,Clinical sciences ,Oncology and carcinogenesis - Abstract
PurposeWomen with HER2-positive breast cancer treated prior to effective anti-HER2 therapy have higher rates of local-regional recurrence (LRR) than those with HER2-negative disease. Effective systemic therapy, however, has been shown to decrease LRR. This study examines LRR in women with HER2-positive breast cancer treated on a single-arm prospective multicenter trial of adjuvant trastuzumab (H) and paclitaxel (T).MethodsPatients with HER2-positive tumors ≤ 3.0 cm with negative axillary nodes or micrometastatic disease were eligible. Systemic therapy included weekly T and H for 12 weeks followed by continuation of H to complete 1 year. Radiation therapy (RT) was required following breast-conserving surgery (BCS), but dose and fields were not specified. Disease-free survival (DFS) and LRR-free survival were calculated using the Kaplan-Meier method.ResultsOf the 410 patients enrolled from September 2007 to September 2010, 406 initiated protocol therapy and formed the basis of this analysis. A total of 272 (67%) had hormone receptor-positive tumors. Of 162 patients undergoing mastectomy, local therapy records were unavailable for two. None of the 160 for whom records were available received RT. Among 244 BCS patients, detailed RT records were available for 217 (89%). With a median follow-up of 6.5 years, 7-year DFS was 93.3% (95% CI 90.4-96.2), and LRR-free survival was 98.6% (95% CI 97.4-99.8).ConclusionLRR in this select group of early-stage patients with HER2-positive disease receiving effective anti-HER2 therapy is extremely low. If confirmed in additional studies, future investigational efforts should focus on de-escalating local therapy.
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- 2019
20. Assessment of patient navigation programs for breast cancer patients across the city of Boston
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LeClair, Amy M., Battaglia, Tracy A., Casanova, Nicole L., Haas, Jennifer S., Freund, Karen M., Moy, Beverly, Parsons, Susan K., Ko, Naomi Y., Ross, JoEllen, Ohrenberger, Ellen, Mullikin, Katelyn R., and Lemon, Stephenie C.
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- 2022
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21. Abstract PR08: Intratumoral heterogeneity drives resistance to Antibody Drug Conjugate therapy: Analysis of the NeoSTAR trial of neoadjuvant Sacituzumab govitecan for localized TNBC
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Spring, Laura M., primary, Wu, Bogang, additional, Liu, Ting, additional, Geisberg, Jacob, additional, Cristea, Simona, additional, Bossuyt, Veerle, additional, Abelman, Rachel Occhiogrosso, additional, Peiris, Nicole, additional, Coates, James, additional, Koh, Siang-Boon, additional, Zhang, Mengran, additional, Ryan, Lianne, additional, Moy, Beverly, additional, Isakoff, Steven J., additional, Tolaney, Sara M., additional, Michor, Franziska, additional, Bardia, Aditya, additional, and Ellisen, Leif W., additional
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- 2024
- Full Text
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22. Systemic Treatment of Patients With Metastatic Breast Cancer: ASCO Resource–Stratified Guideline
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Al Sukhun, Sana, primary, Temin, Sarah, additional, Barrios, Carlos H., additional, Antone, Nicoleta Zenovia, additional, Guerra, Yanin Chavarri, additional, Mac Gregor, Mariana Chavez, additional, Chopra, Rakesh, additional, Danso, Michael A., additional, Gomez, Henry Leonidas, additional, Homian, N’Da Marcelin, additional, Kandil, Alaa, additional, Kithaka, Benda, additional, Koczwara, Bogda, additional, Moy, Beverly, additional, Nakigudde, Gertrude, additional, Petracci, Fernando Enrique, additional, Rugo, Hope S., additional, El Saghir, Nagi S., additional, and Arun, Banu K., additional
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- 2024
- Full Text
- View/download PDF
23. Community Collaboration To Advance Racial/Ethnic Equity in Colorectal Cancer Screening: Protocol for a Multilevel Intervention to Improve Screening, Follow-Up, and Biorepository Participation in Community Health Centers
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May, Folasade P., primary, Brodney, Suzanne, additional, Tuan, Jessica J., additional, Syngal, Sapna, additional, Chan, Andrew T., additional, Glenn, Beth, additional, Johnson, Gina, additional, Chang, Yuchiao, additional, Drew, David A., additional, Moy, Beverly, additional, Rodriguez, Nicolette J., additional, Warner, Erica, additional, Anyane-Yeboa, Adjoa, additional, Ukaegbu, Chinedu, additional, Davis, Anjelica Q., additional, Schoolcraft, Kimberly, additional, Regan, Susan, additional, Yoguez, Nathan, additional, Kuney, Samantha, additional, Le Beaux, Kelley, additional, Jeffries, Catherine, additional, Lee, Ellen T., additional, Bhat, Roopa, additional, and Haas, Jennifer S., additional
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- 2024
- Full Text
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24. Final Efficacy Results of Neratinib in HER2-positive Hormone Receptor-positive Early-stage Breast Cancer From the Phase III ExteNET Trial
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Chan, Arlene, Moy, Beverly, Mansi, Janine, Ejlertsen, Bent, Holmes, Frankie Ann, Chia, Stephen, Iwata, Hiroji, Gnant, Michael, Loibl, Sibylle, Barrios, Carlos H., Somali, Isil, Smichkoska, Snezhana, Martinez, Noelia, Alonso, Mirta Garcia, Link, John S., Mayer, Ingrid A., Cold, Søren, Murillo, Serafin Morales, Senecal, Francis, Inoue, Kenichi, Ruiz-Borrego, Manuel, Hui, Rina, Denduluri, Neelima, Patt, Debra, Rugo, Hope S., Johnston, Stephen R.D., Bryce, Richard, Zhang, Bo, Xu, Feng, Wong, Alvin, and Martin, Miguel
- Published
- 2021
- Full Text
- View/download PDF
25. Implementation of a Brief Screening Tool to Identify Needs of Breast Cancer Survivors
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McDonough, Allison L., Lei, Yvonne, Kwak, Agnes H., Haggett, Dana E., Jimenez, Rachel B., Johnston, Katherine T., Moy, Beverly, Spring, Laura M., and Peppercorn, Jeffrey
- Published
- 2021
- Full Text
- View/download PDF
26. A phase II study of combined ridaforolimus and dalotuzumab compared with exemestane in patients with estrogen receptor-positive breast cancer
- Author
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Baselga, José, Morales, Serafin M, Awada, Ahmad, Blum, Joanne L, Tan, Antoinette R, Ewertz, Marianne, Cortes, Javier, Moy, Beverly, Ruddy, Kathryn J, Haddad, Tufia, Ciruelos, Eva M, Vuylsteke, Peter, Ebbinghaus, Scot, Im, Ellie, Eaton, Lamar, Pathiraja, Kumudu, Gause, Christine, Mauro, David, Jones, Mary Beth, and Rugo, Hope S
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Oncology and Carcinogenesis ,Clinical Trials and Supportive Activities ,Estrogen ,Patient Safety ,Clinical Research ,Cancer ,Breast Cancer ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Adult ,Aged ,Androstadienes ,Antibodies ,Monoclonal ,Antibodies ,Monoclonal ,Humanized ,Antineoplastic Combined Chemotherapy Protocols ,Aromatase Inhibitors ,Breast Neoplasms ,Disease-Free Survival ,Female ,Humans ,Middle Aged ,Protein Kinase Inhibitors ,Receptors ,Estrogen ,Sirolimus ,Stomatitis ,Ridaforolimus ,mTOR ,Dalotuzumab ,IGF1R ,Breast cancer ,Oncology & Carcinogenesis ,Clinical sciences ,Oncology and carcinogenesis - Abstract
PurposeCombining the mTOR inhibitor ridaforolimus and the anti-IGFR antibody dalotuzumab demonstrated antitumor activity, including partial responses, in estrogen receptor (ER)-positive advanced breast cancer, especially in high proliferation tumors (Ki67 > 15%).MethodsThis randomized, multicenter, international, phase II study enrolled postmenopausal women with advanced ER-positive breast cancer previously treated with a nonsteroidal aromatase inhibitor (NCT01234857). Patients were randomized to either oral ridaforolimus 30 mg daily for 5 of 7 days (once daily [qd] × 5 days/week) plus intravenous dalotuzumab 10 mg/kg/week or oral exemestane 25 mg/day, and stratified by Ki67 status. Due to a high incidence of stomatitis in the ridaforolimus-dalotuzumab group, two sequential, nonrandomized, reduced-dose cohorts were explored with ridaforolimus 20 and 10 mg qd × 5 days/week. The primary endpoint was progression-free survival (PFS).ResultsMedian PFS was 21.4 weeks for ridaforolimus 30 mg qd × 5 days/week plus dalotuzumab 10 mg/kg (n = 29) and 24.3 weeks for exemestane (n = 33; hazard ratio = 1.00; P = 0.5). Overall survival and objective response rates were similar between treatment arms. The incidence of drug-related, nonserious, and serious adverse events was higher with ridaforolimus/dalotuzumab (any ridaforolimus dose) than with exemestane. Lowering the ridaforolimus dose reduced the incidence of grade 3 stomatitis, but overall toxicity remained higher than acceptable at all doses without improved efficacy.ConclusionsThe combination of ridaforolimus plus dalotuzumab was no more effective than exemestane in patients with advanced ER-positive breast cancer, and the incidence of adverse events was higher. Therefore, the combination is not being further pursued.
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- 2017
27. Pre- and Postoperative Neratinib for HER2-Positive Breast Cancer Brain Metastases: Translational Breast Cancer Research Consortium 022
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Freedman, Rachel A., Gelman, Rebecca S., Agar, Nathalie Y.R., Santagata, Sandro, Randall, Elizabeth C., Gimenez-Cassina Lopez, Begoña, Connolly, Roisin M., Dunn, Ian F., Van Poznak, Catherine H., Anders, Carey K., Melisko, Michelle E., Silvestri, Kelly, Cotter, Christine M., Componeschi, Kathryn P., Marte, Juan M., Moy, Beverly, Blackwell, Kimberly L., Puhalla, Shannon L., Ibrahim, Nuhad, Moynihan, Timothy J., Nangia, Julie, Tung, Nadine, Burns, Robyn, Rimawi, Mothaffar F., Krop, Ian E., Wolff, Antonio C., Winer, Eric P., and Lin, Nancy U.
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- 2020
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28. Cardiac Outcomes of Patients Receiving Adjuvant Weekly Paclitaxel and Trastuzumab for Node-Negative, ERBB2-Positive Breast Cancer.
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Dang, Chau, Guo, Hao, Najita, Julie, Yardley, Denise, Marcom, Kelly, Albain, Kathy, Rugo, Hope, Miller, Kathy, Ellis, Matthew, Shapira, Iuliana, Wolff, Antonio, Carey, Lisa, Moy, Beverly, Groarke, John, Moslehi, Javid, Krop, Ian, Burstein, Harold, Hudis, Clifford, Winer, Eric, and Tolaney, Sara
- Subjects
Adult ,Aged ,Aged ,80 and over ,Antineoplastic Combined Chemotherapy Protocols ,Biomarkers ,Tumor ,Breast Neoplasms ,Chemotherapy ,Adjuvant ,Disease-Free Survival ,Drug Administration Schedule ,Female ,Humans ,Middle Aged ,Neoplasm Staging ,Paclitaxel ,Receptor ,ErbB-2 ,Risk Assessment ,Risk Factors ,Stroke Volume ,Time Factors ,Trastuzumab ,Treatment Outcome ,United States ,Ventricular Dysfunction ,Left ,Ventricular Function ,Left ,Young Adult - Abstract
IMPORTANCE: Trastuzumab is a life-saving therapy but is associated with symptomatic and asymptomatic left ventricular ejection fraction (LVEF) decline. We report the cardiac toxic effects of a nonanthracycline and trastuzumab-based treatment for patients with early-stage human epidermal growth factor receptor 2 (ERBB2, formerly HER2 or HER2/neu)-positive breast cancer. OBJECTIVE: To determine the cardiac safety of paclitaxel with trastuzumab and the utility of LVEF monitoring in patients with node-negative, ERBB2-positive breast cancer. DESIGN, SETTING, AND PARTICIPANTS: In this secondary analysis of an uncontrolled, single group study across 14 medical centers, enrollment of 406 patients with node-negative, ERBB2-positive breast cancer 3 cm, or smaller, and baseline LVEF of greater than or equal to 50% occurred from October 9, 2007, to September 3, 2010. Patients with a micrometastasis in a lymph node were later allowed with a study amendment. Median patient age was 55 years, 118 (29%) had hypertension, and 30 (7%) had diabetes. Patients received adjuvant paclitaxel for 12 weeks with trastuzumab, and trastuzumab was continued for 1 year. Median follow-up was 4 years. INTERVENTIONS: Treatment consisted of weekly 80-mg/m2 doses of paclitaxel administered concurrently with trastuzumab intravenously for 12 weeks, followed by trastuzumab monotherapy for 39 weeks. During the monotherapy phase, trastuzumab could be administered weekly 2-mg/kg or every 3 weeks as 6-mg/kg. Radiation and hormone therapy were administered per standard guidelines after completion of the 12 weeks of chemotherapy. Patient LVEF was assessed at baseline, 12 weeks, 6 months, and 1 year. MAIN OUTCOMES AND MEASURES: Cardiac safety data, including grade 3 to 4 left ventricular systolic dysfunction (LVSD) and significant asymptomatic LVEF decline, as defined by our study, were reported. RESULTS: Overall, 2 patients (0.5%) (95% CI, 0.1%-1.8%) developed grade 3 LVSD and came off study, and 13 (3.2%) (95% CI, 1.9%-5.4%) had significant asymptomatic LVEF decline, 11 of whom completed study treatment. Median LVEF at baseline was 65%; 12 weeks, 64%; 6 months, 64%; and 1 year, 64%. CONCLUSIONS AND RELEVANCE: Cardiac toxic effects from paclitaxel with trastuzumab, manifesting as grade 3 or 4 LVSD or asymptomatic LVEF decline, were low. Patient LVEF was assessed at baseline, 12 weeks, 6 months, and 1 year, and our findings suggest that LVEF monitoring during trastuzumab therapy without anthracyclines could be simplified for many individuals.
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- 2016
29. ASCO Ethical Guidance for the Practical Management of Oncology Drug Shortages
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Hantel, Andrew, primary, Spence, Rebecca, additional, Camacho, Polo, additional, Bradbury, Angela R., additional, Denburg, Avram E., additional, Jagsi, Reshma, additional, Moy, Beverly, additional, Rathmell, W. Kimryn, additional, Rosenberg, Abby R., additional, Symington, Banu, additional, Marron, Jonathan M., additional, and Peppercorn, Jeffrey, additional
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- 2023
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- View/download PDF
30. Falls prechemotherapy and toxicity‐related hospitalization during adjuvant chemotherapy for breast cancer in older women: Results from the prospective multicenter HOPE trial
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Ji, Jingran, primary, Bae, Marie, additional, Sun, Can‐Lan, additional, Wildes, Tanya M., additional, Freedman, Rachel A., additional, Magnuson, Allison, additional, O'Connor, Tracey, additional, Moy, Beverly, additional, Klepin, Heidi D., additional, Chapman, Andrew E., additional, Tew, William P., additional, Dotan, Efrat, additional, Fenton, Mary Anne, additional, Kim, Heeyoung, additional, Katheria, Vani, additional, Gross, Cary P., additional, Cohen, Harvey J., additional, Muss, Hyman B., additional, and Sedrak, Mina S., additional
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- 2023
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31. A system for risk stratification and prioritization of breast cancer surgeries delayed by the COVID-19 pandemic: preparing for re-entry
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Smith, Barbara L., Nguyen, Anvy, Korotkin, Jenna E., Kelly, Bridget N., Specht, Michelle C., Spring, Laura M., Moy, Beverly, Isakoff, Steven J., and Gadd, Michele A.
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- 2020
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32. Phase 1b clinical trial of ado-trastuzumab emtansine and ribociclib for HER2-positive metastatic breast cancer
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Spring, Laura M., Clark, Shealagh L., Li, Tianyu, Goel, Shom, Tayob, Nabihah, Viscosi, Elene, Abraham, Elizabeth, Juric, Dejan, Isakoff, Steven J., Mayer, Erica, Moy, Beverly, Supko, Jeffrey G., Tolaney, Sara M., and Bardia, Aditya
- Published
- 2021
- Full Text
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33. Single-arm, open-label phase 2 trial of pembrolizumab in patients with leptomeningeal carcinomatosis
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Brastianos, Priscilla K., Lee, Eudocia Quant, Cohen, Justine V., Tolaney, Sara M., Lin, Nancy U., Wang, Nancy, Chukwueke, Ugonma, White, Michael D., Nayyar, Naema, Kim, Albert, Alvarez-Breckenridge, Christopher, Krop, Ian, Mahar, Maura Keeley, Bertalan, Mia S., Shaw, Brian, Mora, Joana L., Goss, Nathaniel, Subramanian, Megha, Nayak, Lakshmi, Dietrich, Jorg, Forst, Deborah A., Nahed, Brian V., Batchelor, Tracy T., Shih, Helen A., Gerstner, Elizabeth R., Moy, Beverly, Lawrence, Donald, Giobbie-Hurder, Anita, Carter, Scott L., Oh, Kevin, Cahill, Daniel P., and Sullivan, Ryan J.
- Published
- 2020
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34. Variation in type of adjuvant chemotherapy received among patients with stage I breast cancer: A multi‐institutional study
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Vaz-Luis, Ines, Hughes, Melissa E, Cronin, Angel M, Rugo, Hope S, Edge, Stephen B, Moy, Beverly, Theriault, Richard L, Hassett, Michael J, Winer, Eric P, and Lin, Nancy U
- Subjects
Cancer ,Breast Cancer ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Aged ,Breast Neoplasms ,Chemotherapy ,Adjuvant ,Cohort Studies ,Female ,Humans ,Logistic Models ,Middle Aged ,Multivariate Analysis ,Neoplasm Staging ,Prospective Studies ,Receptor ,ErbB-2 ,chemotherapy ,stage I ,breast cancer ,institutional variation ,cost ,Receptor ,erbB-2 ,Oncology and Carcinogenesis ,Public Health and Health Services ,Oncology & Carcinogenesis - Abstract
BackgroundAmong patients with stage I breast cancer, there is significant uncertainty concerning the optimal threshold at which to consider chemotherapy, and when considered, there is controversy regarding whether to consider non-intensive versus intensive regimens. The authors examined the types and costs of adjuvant chemotherapy received among patients with stage I breast cancer.MethodsThe current study was a prospective cohort study including patients with stage I breast cancer who were treated at a National Comprehensive Cancer Network center from 2000 through 2009. Stage was defined according to the version of the American Joint Committee on Cancer Staging Manual applicable at the time of diagnosis. Stratifying by human epidermal growth factor receptor 2 (HER2), the authors examined the percentage of patients receiving intensive versus non-intensive chemotherapy regimens and the factors associated with type of chemotherapy administered using multivariable logistic regression. Costs of the most common regimens were estimated.ResultsOf 8907 patients, 33% received adjuvant chemotherapy. Among those individuals, there was an increase in the use of intensive chemotherapy within the last decade, from 31% in 2000 through 2005 to 63% in 2008 through 2009 (including an increase in the use of the combination of docetaxel, carboplatin, and trastuzumab) among patients with HER2-positive disease and from 15% in 2000 through 2005 to 41% in 2008 through 2009 among patients with HER2-negative disease (32% of patients with hormone receptor-positive and 59% of patients with triple-negative disease). Among patients treated with non-intensive regimens, there was an increase in the use of the combination of docetaxel and cyclophosphamide noted, with a decrease in the use of the doxorubicin and cyclophosphamide combination. The choice of regimen varied significantly by institution. The major drivers of cost variation were the incorporation of biologics (eg, trastuzumab) and growth factors, with significant variation even within non-intensive and intensive regimens.ConclusionsOver time, there was an increase in use of intensive regimens among Stage I breast cancer, with striking institutional and cost variations.
- Published
- 2015
35. Chemotherapy-related amenorrhea after adjuvant paclitaxel–trastuzumab (APT trial)
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Ruddy, Kathryn J, Guo, Hao, Barry, William, Dang, Chau T, Yardley, Denise A, Moy, Beverly, Marcom, P Kelly, Albain, Kathy S, Rugo, Hope S, Ellis, Matthew J, Shapira, Iuliana, Wolff, Antonio C, Carey, Lisa A, Overmoyer, Beth A, Hudis, Clifford, Krop, Ian E, Burstein, Harold J, Winer, Eric P, Partridge, Ann H, and Tolaney, Sara M
- Subjects
Clinical Research ,Prevention ,Breast Cancer ,Aging ,Cancer ,Contraception/Reproduction ,Estrogen ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Adult ,Amenorrhea ,Antineoplastic Combined Chemotherapy Protocols ,Breast Neoplasms ,Chemotherapy ,Adjuvant ,Clinical Trials ,Phase II as Topic ,Female ,Follow-Up Studies ,Humans ,Middle Aged ,Neoplasm Grading ,Neoplasm Staging ,Paclitaxel ,Trastuzumab ,Tumor Burden ,Breast cancer ,Chemotherapy ,Fertility ,Premenopausal ,Clinical Sciences ,Oncology and Carcinogenesis ,Oncology & Carcinogenesis - Abstract
Chemotherapy-related amenorrhea (CRA) is associated with infertility and menopausal symptoms. Learning how frequently paclitaxel and trastuzumab cause amenorrhea is important. Most other adjuvant breast cancer therapies induce CRA in approximately 50 % of all premenopausal recipients [1]. 410 patients enrolled on the APT Trial, a single-arm phase 2 adjuvant study of 12 weeks of paclitaxel and trastuzumab followed by nine months of trastuzumab monotherapy. Eligible patients had ≤3 cm node-negative HER2 + breast cancers. Premenopausal enrollees were asked to complete menstrual surveys every 3-12 months for 72 months. Women who responded to at least one survey at least 15 months after chemotherapy initiation (and who did not undergo hysterectomy and/or bilateral oophorectomy or receive ovarian suppressing medications prior to 15 months) were included in this analysis. A participant was defined as having amenorrhea in follow-up if her self-reported last menstrual period at last follow-up was greater than 12 months prior to the survey. Among the 64 women in the evaluable population (median age at study entry 44 years, range 27-52 years), the median time between chemotherapy initiation and last menstrual survey was 51 months (range 16-79). 18 of 64 women (28 %, 95 % CI 18-41 %) were amenorrheic at that time point. Amenorrhea rates among premenopausal women treated with adjuvant paclitaxel and trastuzumab for early stage breast cancer appear lower than those seen historically with standard alkylator-based breast cancer regimens. Future studies are needed to understand the impact of this regimen on related issues of fertility and menopausal symptoms.
- Published
- 2015
36. Risk of Marrow Neoplasms After Adjuvant Breast Cancer Therapy: The National Comprehensive Cancer Network Experience
- Author
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Wolff, Antonio C, Blackford, Amanda L, Visvanathan, Kala, Rugo, Hope S, Moy, Beverly, Goldstein, Lori J, Stockerl-Goldstein, Keith, Neumayer, Leigh, Langbaum, Terry S, Theriault, Richard L, Hughes, Melissa E, Weeks, Jane C, and Karp, Judith E
- Subjects
Clinical Research ,Prevention ,Hematology ,Breast Cancer ,Cancer ,Patient Safety ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Adolescent ,Adult ,Aged ,Aged ,80 and over ,Antineoplastic Combined Chemotherapy Protocols ,Bone Marrow Neoplasms ,Breast Neoplasms ,Cohort Studies ,Databases ,Factual ,Female ,Follow-Up Studies ,Humans ,Incidence ,Mastectomy ,Middle Aged ,Neoplasm Staging ,Outcome Assessment ,Health Care ,Radiotherapy ,Risk Factors ,SEER Program ,Survival Analysis ,United States ,Young Adult ,Clinical Sciences ,Oncology and Carcinogenesis ,Oncology & Carcinogenesis - Abstract
PurposeOutcomes for early-stage breast cancer have improved. First-generation adjuvant chemotherapy trials reported a 0.27% 8-year cumulative incidence of myelodysplastic syndrome/acute myelogenous leukemia. Incomplete ascertainment and follow-up may have underestimated subsequent risk of treatment-associated marrow neoplasm (MN).Patients and methodsWe examined the MN frequency in 20,063 patients with stage I to III breast cancer treated at US academic centers between 1998 and 2007. Time-to-event analyses were censored at first date of new cancer event, last contact date, or death and considered competing risks. Cumulative incidence, hazard ratios (HRs), and comparisons with Surveillance, Epidemiology, and End Results estimates were obtained. Marrow cytogenetics data were reviewed.ResultsFifty patients developed MN (myeloid, n = 42; lymphoid, n = 8) after breast cancer (median follow-up, 5.1 years). Patients who developed MN had similar breast cancer stage distribution, race, and chemotherapy exposure but were older compared with patients who did not develop MN (median age, 59.1 v 53.9 years, respectively; P = .03). Two thirds of patients had complex MN cytogenetics. Risk of MN was significantly increased after surgery plus chemotherapy (HR, 6.8; 95% CI, 1.3 to 36.1) or after all modalities (surgery, chemotherapy, and radiation; HR, 7.6; 95% CI, 1.6 to 35.8), compared with no treatment with chemotherapy. MN rates per 1,000 person-years were 0.16 (surgery), 0.43 (plus radiation), 0.46 (plus chemotherapy), and 0.54 (all three modalities). Cumulative incidence of MN doubled between years 5 and 10 (0.24% to 0.48%); 9% of patients were alive at 10 years.ConclusionIn this large early-stage breast cancer cohort, MN risk after radiation and/or adjuvant chemotherapy was low but higher than previously described. Risk continued to increase beyond 5 years. Individual risk of MN must be balanced against the absolute survival benefit of adjuvant chemotherapy.
- Published
- 2015
37. Adjuvant Paclitaxel and Trastuzumab for Node-Negative, HER2-Positive Breast Cancer
- Author
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Tolaney, Sara M, Barry, William T, Dang, Chau T, Yardley, Denise A, Moy, Beverly, Marcom, P Kelly, Albain, Kathy S, Rugo, Hope S, Ellis, Matthew, Shapira, Iuliana, Wolff, Antonio C, Carey, Lisa A, Overmoyer, Beth A, Partridge, Ann H, Guo, Hao, Hudis, Clifford A, Krop, Ian E, Burstein, Harold J, and Winer, Eric P
- Subjects
Cancer ,Clinical Research ,Clinical Trials and Supportive Activities ,Breast Cancer ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Adenocarcinoma ,Adult ,Aged ,Aged ,80 and over ,Antibodies ,Monoclonal ,Humanized ,Antineoplastic Combined Chemotherapy Protocols ,Breast Neoplasms ,Chemotherapy ,Adjuvant ,Disease-Free Survival ,Female ,Follow-Up Studies ,Humans ,Infusions ,Intravenous ,Mastectomy ,Segmental ,Middle Aged ,Neoplasm Recurrence ,Local ,Paclitaxel ,Radiotherapy ,Receptor ,ErbB-2 ,Survival Rate ,Trastuzumab ,Receptor ,erbB-2 ,Medical and Health Sciences ,General & Internal Medicine - Abstract
BackgroundNo single standard treatment exists for patients with small, node-negative, human epidermal growth factor receptor type 2 (HER2)-positive breast cancers, because most of these patients have been ineligible for the pivotal trials of adjuvant trastuzumab.MethodsWe performed an uncontrolled, single-group, multicenter, investigator-initiated study of adjuvant paclitaxel and trastuzumab in 406 patients with tumors measuring up to 3 cm in greatest dimension. Patients received weekly treatment with paclitaxel and trastuzumab for 12 weeks, followed by 9 months of trastuzumab monotherapy. The primary end point was survival free from invasive disease.ResultsThe median follow-up period was 4.0 years. The 3-year rate of survival free from invasive disease was 98.7% (95% confidence interval [CI], 97.6 to 99.8). Among the 12 relapses seen, 2 were due to distant metastatic breast cancer. Excluding contralateral HER2-negative breast cancers and nonbreast cancers, 7 disease-specific events were noted. A total of 13 patients (3.2%; 95% CI, 1.7 to 5.4) reported at least one episode of grade 3 neuropathy, and 2 had symptomatic congestive heart failure (0.5%; 95% CI, 0.1 to 1.8), both of whom had normalization of the left ventricular ejection fraction after discontinuation of trastuzumab. A total of 13 patients had significant asymptomatic declines in ejection fraction (3.2%; 95% CI, 1.7 to 5.4), as defined by the study, but 11 of these patients were able to resume trastuzumab therapy after a brief interruption.ConclusionsAmong women with predominantly stage I HER2-positive breast cancer, treatment with adjuvant paclitaxel plus trastuzumab was associated with a risk of early recurrence of about 2%; 6% of patients withdrew from the study because of protocol-specified adverse events. (Funded by Genentech; ClinicalTrials.gov number, NCT00542451.).
- Published
- 2015
38. Outcomes by Tumor Subtype and Treatment Pattern in Women With Small, Node-Negative Breast Cancer: A Multi-Institutional Study
- Author
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Vaz-Luis, Ines, Ottesen, Rebecca A, Hughes, Melissa E, Mamet, Rizvan, Burstein, Harold J, Edge, Stephen B, Gonzalez-Angulo, Ana M, Moy, Beverly, Rugo, Hope S, Theriault, Richard L, Weeks, Jane C, Winer, Eric P, and Lin, Nancy U
- Subjects
Cancer ,Breast Cancer ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Good Health and Well Being ,Adult ,Aged ,Antibodies ,Monoclonal ,Humanized ,Antineoplastic Combined Chemotherapy Protocols ,Biomarkers ,Tumor ,Breast Neoplasms ,Chemotherapy ,Adjuvant ,Disease-Free Survival ,Female ,Follow-Up Studies ,Humans ,Mastectomy ,Segmental ,Middle Aged ,Neoplasm Staging ,Prognosis ,Prospective Studies ,Receptor ,ErbB-2 ,Receptors ,Estrogen ,Receptors ,Progesterone ,Trastuzumab ,Treatment Outcome ,Triple Negative Breast Neoplasms ,United States ,Receptor ,erbB-2 ,Clinical Sciences ,Oncology and Carcinogenesis ,Oncology & Carcinogenesis - Abstract
PurposeTreatment decisions for patients with T1a,bN0M0 breast cancer are challenging. We studied the time trends in use of adjuvant chemotherapy and survival outcomes among these patients.Patients and methodsThis was a prospective cohort study within the National Comprehensive Cancer Network Database that included 4,113 women with T1a,bN0M0 breast cancer treated between 2000 and 2009. Tumors were grouped by size (T1a, T1b), biologic subtype defined by hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status, and receipt of chemotherapy with or without trastuzumab.ResultsMedian follow-up time was 5.5 years. Eight percent of patients with HR-positive/HER2-negative tumors were treated with chemotherapy. Fifty-two percent of those with HER2-positive or HR-negative/HER2-negative breast cancers received chemotherapy, with an increase over the last decade. Survival outcomes diverged by subtype and size, but the 5-year distant relapse-free survival (DRFS) did not exceed 10% in any subgroup. The 5-year DRFS for patients with T1a tumors untreated with chemotherapy ranged from 93% to 98% (n = 49 to 972), and for patients with T1b tumors, it ranged from 90% to 96% (n = 17 to 2,005). Patients with HR-positive/HER2-negative disease had the best DRFS estimates, and patients with HR-negative/HER2-negative tumors had the lowest. In this observational, nonrandomized cohort study, the 5-year DRFS for treated patients with T1a tumors was 100% for all subgroups (n = 12 to 33), and for patients with T1b tumors, it ranged from 94% to 96% (n = 88 to 241).ConclusionWomen with T1a,b tumors have an excellent prognosis without chemotherapy. Size and tumor subtype may identify patients in whom the rate of recurrence justifies consideration of chemotherapy. These patients represent an optimal group for evaluating less toxic adjuvant regimens to maintain efficacy while minimizing short- and long-term risks.
- Published
- 2014
39. Falls prechemotherapy and toxicity‐related hospitalization during adjuvant chemotherapy for breast cancer in older women: Results from the prospective multicenter HOPE trial.
- Author
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Ji, Jingran, Bae, Marie, Sun, Can‐Lan, Wildes, Tanya M., Freedman, Rachel A., Magnuson, Allison, O'Connor, Tracey, Moy, Beverly, Klepin, Heidi D., Chapman, Andrew E., Tew, William P., Dotan, Efrat, Fenton, Mary Anne, Kim, Heeyoung, Katheria, Vani, Gross, Cary P., Cohen, Harvey J., Muss, Hyman B., and Sedrak, Mina S.
- Subjects
ADJUVANT chemotherapy ,BREAST cancer ,CANCER chemotherapy ,OLDER women ,OLDER people - Abstract
Background: Older women with breast cancer frequently experience toxicity‐related hospitalizations during adjuvant chemotherapy. Although the geriatric assessment can identify those at risk, its use in clinic remains limited. One simple, low‐cost marker of vulnerability in older persons is fall history. Here, the authors examined whether falls prechemotherapy can identify older women at risk for toxicity‐related hospitalization during adjuvant chemotherapy for breast cancer. Methods: In a prospective study of women >65 years old with stage I–III breast cancer treated with adjuvant chemotherapy, the authors assessed baseline falls in the past 6 months as a categorical variable: no fall, one fall, and more than one fall. The primary end point was incident hospitalization during chemotherapy attributable to toxicity. Multivariable logistic regression was used to examine the association between falls and toxicity‐related hospitalization, adjusting for sociodemographic, disease, and geriatric covariates. Results: Of the 497 participants, 60 (12.1%) reported falling before chemotherapy, and 114 (22.9%) had one or more toxicity‐related hospitalizations. After adjusting for sociodemographic, disease, and geriatric characteristics, women who fell more than once within 6 months before chemotherapy had greater odds of being hospitalized from toxicity during chemotherapy compared to women who did not fall (50.0% vs. 20.8% experienced toxicity‐related hospitalization, odds ratio, 4.38; 95% confidence interval, 1.66–11.54, p =.003). Conclusions: In this cohort of older women with early breast cancer, women who experienced more than one fall before chemotherapy had an over 4‐fold increased risk of toxicity‐related hospitalization during chemotherapy, independent of sociodemographic, disease, and geriatric factors. In this study, nearly one in four older women with early breast cancer experienced toxicity‐related hospitalization during chemotherapy. Women who reported more than one fall in the 6 months leading up to chemotherapy had a greater than four times higher odds of experiencing toxicity‐related hospitalization during treatment than women who reported no falls. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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40. ASCO Ethical Guidance for the Practical Management of Oncology Drug Shortages.
- Author
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Hantel, Andrew, Spence, Rebecca, Camacho, Polo, Bradbury, Angela R., Denburg, Avram E., Jagsi, Reshma, Moy, Beverly, Rathmell, W. Kimryn, Rosenberg, Abby R., Symington, Banu, Marron, Jonathan M., and Peppercorn, Jeffrey
- Published
- 2024
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41. Virtual Molecular and Precision Medicine Clinic to Improve Access to Clinical Trials for Patients With Metastatic Breast Cancer: An Academic/Community Collaboration.
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Spring, Laura M., Mortensen, Lindsey, Abraham, Elizabeth, Keenan, Jennifer, Medford, Arielle, Ma, Annie, Padden, Sarah, Denault, Elyssa, Ryan, Lianne, Iafrate, A. John, Lennerz, Jochen, Hochberg, Ephraim, Wander, Seth A., Moy, Beverly, Isakoff, Steven J., Juric, Dejan, Brennan, Kimberly A., Smith, Deborah E., Civiello, Barbara, and Mulvey, Therese
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BREAST tumor treatment ,CLINICAL trials ,HUMAN research subjects ,METASTASIS ,GENETIC testing ,MEDICAL care ,CANCER patients ,SURVEYS ,HUMAN services programs ,CONCEPTUAL structures ,QUALITY assurance ,MEDICAL referrals ,HEALTH care teams ,GENOMICS ,DATA analysis software ,BREAST tumors ,TELEMEDICINE - Abstract
PURPOSE There is a demand for improved care delivery surrounding genomic testing and clinical trial enrollment among patients with metastatic breast cancer (MBC). We sought to improve the current process via real-time informal consultation and prescreening assessment for patients with MBC treated by community and academic medical oncologists by implementing a virtual molecular and precision medicine (vMAP) clinic. METHODS The vMAP program used a virtual referral system directed to a multidisciplinary team with precision medicine expertise. Providers contacted vMAP regarding patients with MBC, and on receipt of referral, the vMAP team engaged in discussion to identify if further diagnostics were needed (including genomic testing) and to identify potential clinical trials or standard treatment options. Recommendations were then sent to the referring provider within 72 hours. Pre-/postsurveys were issued to network physicians to assess for barriers, clinical trial access, and vMAP referral experience. Program implementation was evaluated with the Squire 2.0 reporting guidelines for quality improvement in health care as a framework. RESULTS Eighty-one cases from 22 providers were referred to vMAP over a 26-month period. The average response time to the referring provider with a finalized recommendation was 1.90 ± 1.82 days. A total of 86.4% of cases had clinical trial options on vMAP prescreen, with 40.7% initiating formal screening assessments and 27 patients (33.3%) ultimately enrolling on trials. On resurvey, 92% of survey responses across community oncology referring providers said that they were very likely to use vMAP again. CONCLUSION In the initial 2-year period, vMAP demonstrated an efficient means to offer real-time interpretation of genomic testing and identification of clinical trials for patients with MBC, with effective clinical trial enrollment and high rates of referring provider satisfaction. [ABSTRACT FROM AUTHOR]
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- 2024
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42. Chemotherapy and Targeted Therapy for Endocrine-Pretreated or Hormone Receptor–Negative Metastatic Breast Cancer and Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: ASCO Guideline Rapid Recommendation Update Q and A
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Moy, Beverly, primary, Wolff, Antonio C., additional, Rumble, R. Bryan, additional, Allison, Kimberly H., additional, and Carey, Lisa A., additional
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- 2023
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43. Molecular Residual Disease in Breast Cancer: Detection and Therapeutic Interception
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Medford, Arielle J., primary, Moy, Beverly, additional, Spring, Laura M., additional, Hurvitz, Sara A., additional, Turner, Nicholas C., additional, and Bardia, Aditya, additional
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- 2023
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44. Impact of hormone receptor status on patterns of recurrence and clinical outcomes amongpatients with human epidermal growth factor-2-positive breast cancer in the National Comprehensive Cancer Network: a prospective cohort study
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Vaz-Luis, Ines, Ottesen, Rebecca A, Hughes, Melissa E, Marcom, P Kelly, Moy, Beverly, Rugo, Hope S, Theriault, Richard L, Wilson, John, Niland, Joyce C, Weeks, Jane C, and Lin, Nancy U
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Abstract Introduction In gene expression experiments, hormone receptor (HR)-positive/human epidermal growth factor-2 (HER2)-positive tumors generally cluster within the luminal B subset; whereas HR-negative/HER2-positive tumors reside in the HER2-enriched subset. We investigated whether the clinical behavior of HER2-positive tumors differs by HR status. Methods We evaluated 3,394 patients who presented to National Comprehensive Cancer Network (NCCN) centers with stage I to III HER2-positive breast cancer between 2000 and 2007. Tumors were grouped as HR-positive/HER2-positive (HR+/HER2+) or HR-negative/HER2-positive (HR-/HER2+). Chi-square, logistic regression and Cox hazard proportional regression were used to compare groups. Results Median follow-up was four years. Patients with HR-/HER2+ tumors (n = 1,379, 41% of total) were more likely than those with HR+/HER-2+ disease (n = 2,015, 59% of total) to present with high histologic grade and higher stages (P
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- 2012
45. Effectiveness and tolerability of neoadjuvant pertuzumab-containing regimens for HER2-positive localized breast cancer
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Spring, Laura, Niemierko, Andrzej, Haddad, Stephanie, Yuen, Megan, Comander, Amy, Reynolds, Kerry, Shin, Jennifer, Bahn, Atul, Brachtel, Elena, Specht, Michelle, Smith, Barbara L., Taghian, Alphonse, Jimenez, Rachel, Peppercorn, Jeffrey, Isakoff, Steven J., Moy, Beverly, and Bardia, Aditya
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- 2018
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46. A Gene Panel Associated With Abemaciclib Utility in ESR1-Mutated Breast Cancer After Prior Cyclin-Dependent Kinase 4/6-Inhibitor Progression
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Brett, Jamie O., primary, Dubash, Taronish D., additional, Johnson, Gabriela N., additional, Niemierko, Andrzej, additional, Mariotti, Veronica, additional, Kim, Leslie S.L., additional, Xi, Jing, additional, Pandey, Apurva, additional, Dunne, Siobhan, additional, Nasrazadani, Azadeh, additional, Lloyd, Maxwell R., additional, Kambadakone, Avinash, additional, Spring, Laura M., additional, Micalizzi, Douglas S., additional, Onozato, Maristela L., additional, Che, Dante, additional, Nayar, Utthara, additional, Brufsky, Adam, additional, Kalinsky, Kevin, additional, Ma, Cynthia X., additional, O'Shaughnessy, Joyce, additional, Han, Hyo S., additional, Iafrate, Anthony J., additional, Ryan, Lianne Y., additional, Juric, Dejan, additional, Moy, Beverly, additional, Ellisen, Leif W., additional, Maheswaran, Shyamala, additional, Wagle, Nikhil, additional, Haber, Daniel A., additional, Bardia, Aditya, additional, and Wander, Seth A., additional
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- 2023
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47. Data from AR Expression in Breast Cancer CTCs Associates with Bone Metastases
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Aceto, Nicola, primary, Bardia, Aditya, primary, Wittner, Ben S., primary, Donaldson, Maria C., primary, O'Keefe, Ryan, primary, Engstrom, Amanda, primary, Bersani, Francesca, primary, Zheng, Yu, primary, Comaills, Valentine, primary, Niederhoffer, Kira, primary, Zhu, Huili, primary, Mackenzie, Olivia, primary, Shioda, Toshi, primary, Sgroi, Dennis, primary, Kapur, Ravi, primary, Ting, David T., primary, Moy, Beverly, primary, Ramaswamy, Sridhar, primary, Toner, Mehmet, primary, Haber, Daniel A., primary, and Maheswaran, Shyamala, primary
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- 2023
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48. Supplementary Tables from AR Expression in Breast Cancer CTCs Associates with Bone Metastases
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Aceto, Nicola, primary, Bardia, Aditya, primary, Wittner, Ben S., primary, Donaldson, Maria C., primary, O'Keefe, Ryan, primary, Engstrom, Amanda, primary, Bersani, Francesca, primary, Zheng, Yu, primary, Comaills, Valentine, primary, Niederhoffer, Kira, primary, Zhu, Huili, primary, Mackenzie, Olivia, primary, Shioda, Toshi, primary, Sgroi, Dennis, primary, Kapur, Ravi, primary, Ting, David T., primary, Moy, Beverly, primary, Ramaswamy, Sridhar, primary, Toner, Mehmet, primary, Haber, Daniel A., primary, and Maheswaran, Shyamala, primary
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- 2023
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49. Supplementary Figures S1 - S10 from AR Expression in Breast Cancer CTCs Associates with Bone Metastases
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Aceto, Nicola, primary, Bardia, Aditya, primary, Wittner, Ben S., primary, Donaldson, Maria C., primary, O'Keefe, Ryan, primary, Engstrom, Amanda, primary, Bersani, Francesca, primary, Zheng, Yu, primary, Comaills, Valentine, primary, Niederhoffer, Kira, primary, Zhu, Huili, primary, Mackenzie, Olivia, primary, Shioda, Toshi, primary, Sgroi, Dennis, primary, Kapur, Ravi, primary, Ting, David T., primary, Moy, Beverly, primary, Ramaswamy, Sridhar, primary, Toner, Mehmet, primary, Haber, Daniel A., primary, and Maheswaran, Shyamala, primary
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- 2023
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50. Qualitative study of Oncology Clinicians’ Perceptions of Barriers to Offering Clinical Trials to Underserved Populations
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Perez, Giselle K., primary, Oberoi, Anjali R., additional, Finkelstein-Fox, Lucy, additional, Park, Elyse R., additional, Nipp, Ryan D., additional, and Moy, Beverly, additional
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- 2023
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