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3. Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance)

Author

Rugo, Hope S, Barry, William T, Moreno-Aspitia, Alvaro, Lyss, Alan P, Cirrincione, Constance, Leung, Eleanor, Mayer, Erica L, Naughton, Michael, Toppmeyer, Deborah, Carey, Lisa A, Perez, Edith A, Hudis, Clifford, and Winer, Eric P

Subjects
Clinical Research, Clinical Trials and Supportive Activities, Cancer, Breast Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Albumins, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Bevacizumab, Breast Neoplasms, Drug Administration Schedule, Epothilones, Female, Humans, Middle Aged, Nanoparticles, Neoplasm Metastasis, Neoplasm Recurrence, Local, Paclitaxel, Treatment Outcome, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeWe compared nab-paclitaxel or ixabepilone once per week to paclitaxel with bevacizumab as first-line therapy for patients with advanced breast cancer (BC) to evaluate progression-free survival (PFS) for nab-paclitaxel or ixabepilone versus paclitaxel.Patients and methodsEligible patients were age ≥ 18 years with chemotherapy-naive advanced BC. Patients were randomly assigned to bevacizumab with paclitaxel 90 mg/m(2) (arm A), nab-paclitaxel 150 mg/m(2) (arm B), or ixabepilone 16 mg/m(2) (arm C), once per week for 3 of 4 weeks. Planned enrollment was 900 patients, which would give 88% power to detect a hazard ratio of 0.73.ResultsIn all, 799 patients were enrolled, and 783 received treatment (97% received bevacizumab). Arm C was closed for futility at the first interim analysis (n = 241), and arm A (n = 267) and arm B (n = 275) were closed for futility at the second interim analysis. Median PFS for paclitaxel was 11 months, ixabepilone was inferior to paclitaxel (PFS, 7.4 months; hazard ratio, 1.59; 95% CI, 1.31 to 1.93; P < .001), and nab-paclitaxel was not superior to paclitaxel (PFS, 9.3 months; hazard ratio, 1.20; 95% CI, 1.00 to 1.45; P = .054). Results were concordant with overall survival; time to treatment failure was significantly shorter in both experimental arms v paclitaxel. Hematologic and nonhematologic toxicity, including peripheral neuropathy, was increased with nab-paclitaxel, with more frequent and earlier dose reductions.ConclusionIn patients with chemotherapy-naive advanced BC, ixabepilone once per week was inferior to paclitaxel, and nab-paclitaxel was not superior with a trend toward inferiority. Toxicity was increased in the experimental arms, particularly for nab-paclitaxel. Paclitaxel once per week remains the preferred palliative chemotherapy in this setting.

Published
2015

4. TBCRC009: A Multicenter Phase II Clinical Trial of Platinum Monotherapy With Biomarker Assessment in Metastatic Triple-Negative Breast Cancer

Author

Isakoff, Steven J, Mayer, Erica L, He, Lei, Traina, Tiffany A, Carey, Lisa A, Krag, Karen J, Rugo, Hope S, Liu, Minetta C, Stearns, Vered, Come, Steven E, Timms, Kirsten M, Hartman, Anne-Renee, Borger, Darrel R, Finkelstein, Dianne M, Garber, Judy E, Ryan, Paula D, Winer, Eric P, Goss, Paul E, and Ellisen, Leif W

Subjects
Genetics, Cancer, Clinical Research, Clinical Trials and Supportive Activities, Breast Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adult, Aged, Antineoplastic Agents, BRCA1 Protein, BRCA2 Protein, Biomarkers, Tumor, Carboplatin, Cisplatin, Class I Phosphatidylinositol 3-Kinases, Drug Administration Schedule, Female, Gene Expression Profiling, Gene Expression Regulation, Neoplastic, Genomic Instability, Heterozygote, Humans, Loss of Heterozygosity, Middle Aged, Mutation, Neoplasm Staging, Phosphatidylinositol 3-Kinases, Treatment Outcome, Triple Negative Breast Neoplasms, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeThe identification of patients with metastatic triple-negative breast cancer (mTNBC) who are expected to benefit from platinum-based chemotherapy is of interest. We conducted a single-arm phase II clinical trial of single-agent platinum for mTNBC with biomarker correlates.Patients and methodsPatients with mTNBC received first- or second-line cisplatin (75 mg/m(2)) or carboplatin (area under the concentration-time curve 6) by physician's choice once every 3 weeks. Coprimary end points were objective response rate (RR) and response prediction by p63/p73 gene expression. Secondary and exploratory end points included toxicity assessment, RR in cisplatin versus carboplatin, and RR in molecularly defined subgroups, including BRCA1/2 mutation carriers.ResultsPatients (N = 86; 69 as first-line therapy) received cisplatin (n = 43) or carboplatin (n = 43). RR was 25.6% (95% CI, 16.8% to 36%) and was numerically higher with cisplatin (32.6%) than with carboplatin (18.7%). RR was 54.5% in patients with germline BRCA1/2 mutations (n = 11). In patients without BRCA1/2 mutations (n = 66), exploratory analyses showed that a BRCA-like genomic instability signature (n = 32) discriminated responding and nonresponding tumors (mean homologous recombination deficiency-loss of heterozygosity/homologous recombination deficiency-large-scale state transitions [HRD-LOH/HRD-LST] scores were 12.68 and 5.11, respectively), whereas predefined analysis by p63/p73 expression status (n = 61), p53 and PIK3CA mutation status (n = 53), or PAM50 gene expression subtype (n = 55) did not. Five of the six long-term responders alive at a median of 4.5 years lacked germline BRCA1/2 mutations, and two of them had increased tumor HRD-LOH/HRD-LST scores.ConclusionPlatinum agents are active in mTNBC, especially in patients with germline BRCA1/2 mutations. A measure of tumor DNA repair function may identify patients without mutations who could benefit from platinum therapy agents. Prospective controlled confirmatory trials are warranted.

Published
2015

5. TBCRC 001: Randomized Phase II Study of Cetuximab in Combination With Carboplatin in Stage IV Triple-Negative Breast Cancer

Author

Carey, Lisa A, Rugo, Hope S, Marcom, P Kelly, Mayer, Erica L, Esteva, Francisco J, Ma, Cynthia X, Liu, Minetta C, Storniolo, Anna Maria, Rimawi, Mothaffar F, Forero-Torres, Andres, Wolff, Antonio C, Hobday, Timothy J, Ivanova, Anastasia, Chiu, Wing-Keung, Ferraro, Madlyn, Burrows, Emily, Bernard, Philip S, Hoadley, Katherine A, Perou, Charles M, and Winer, Eric P

Subjects
Biotechnology, Genetics, Breast Cancer, Clinical Trials and Supportive Activities, Cancer, Clinical Research, Human Genome, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Breast Neoplasms, Carboplatin, Cetuximab, Disease Progression, Female, Humans, Middle Aged, Neoplasm Staging, Receptor, ErbB-2, Receptors, Estrogen, Receptors, Progesterone, Signal Transduction, Survival Analysis, Treatment Outcome, Receptor, erbB-2, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeEpidermal growth factor receptor (EGFR) is a targetable receptor frequently overexpressed in basal-like breast cancer, which comprises most triple-negative breast cancers (TNBCs), the only subtype without established targeted therapy.Patients and methodsIn this randomized phase II trial, patients with metastatic TNBC received anti-EGFR antibody cetuximab (400 mg/m(2) load then 250 mg/m(2) per week intravenously [IV]) alone, with carboplatin (area under the curve of 2, once per week IV) added after progression or as concomitant therapy from the beginning. Response rate (RR) was the primary end point; others included time to progression (TTP), overall survival (OS), and toxicity. Embedded correlative studies included molecular subtyping on archival tissue. Fresh tumor tissue before and after 7 to 14 days of therapy was used for microarray analyses exploring EGFR pathway activity and inhibition.ResultsIn 102 patients with TNBC, RRs were 6% (two of 31) to cetuximab and 16% (four of 25) to cetuximab plus carboplatin after progression. RR to those treated from the beginning with cetuximab plus carboplatin was 17% (12 of 71); 31% of patients responded or had prolonged disease stabilization. The cetuximab plus carboplatin regimen was well tolerated, but both TTP and OS were short at 2.1 months (95% CI, 1.8 to 5.5 months) and 10.4 months (95% CI, 7.7 to 13.1 months), respectively. Of 73 patients with archival tissue for analysis, 74% had basal-like molecular subtype. Sixteen patients had tumor biopsies before and 1 week after therapy; genomic patterns of the EGFR pathway showed activation in 13 and inhibition by therapy in five.ConclusionDespite strong preclinical data, combination cetuximab plus carboplatin in metastatic TNBC produced responses in fewer than 20% of patients. EGFR pathway analysis showed that most TNBCs involved activation. However, cetuximab blocked expression of the EGFR pathway in only a minority, suggesting that most had alternate mechanisms for pathway activation.

Published
2012

6. Design of SERENA-6, a phase III switching trial of camizestrant in ESR1-mutant breast cancer during first-line treatment

Author

Turner, Nicholas, primary, Huang-Bartlett, Cynthia, additional, Kalinsky, Kevin, additional, Cristofanilli, Massimo, additional, Bianchini, Giampaolo, additional, Chia, Stephen, additional, Iwata, Hiroji, additional, Janni, Wolfgang, additional, Ma, Cynthia X, additional, Mayer, Erica L, additional, Park, Yeon Hee, additional, Fox, Steven, additional, Liu, Xiaochun, additional, McClain, Sasha, additional, and Bidard, Francois-Clement, additional

Published
2023
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7. Clonal Hematopoiesis in Older Patients with Breast Cancer Receiving Chemotherapy

Author

Mayerhofer, Christina, primary, Sedrak, Mina S, additional, Hopkins, Judith O, additional, Li, Tianyu, additional, Tayob, Nabihah, additional, Faggen, Meredith G, additional, Sinclair, Natalie F, additional, Chen, Wendy Y, additional, Parsons, Heather A, additional, Mayer, Erica L, additional, Lange, Paulina B, additional, Basta, Ameer S, additional, Perilla-Glen, Adriana, additional, Lederman, Ruth I, additional, Wong, Andrew R, additional, Tiwari, Abhay, additional, McAllister, Sandra S, additional, Mittendorf, Elizabeth A, additional, Gibson, Christopher J, additional, Burstein, Harold J, additional, Kim, Annette S, additional, Freedman, Rachel A, additional, and Miller, Peter G, additional

Published
2023
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8. Abstract PD11-06: PD11-06 Circulating tumor DNA association with residual cancer burden after neoadjuvant therapy in triple negative breast cancer in TBCRC 030

Author

Parsons, Heather A., primary, Blewett, Timothy, additional, Chu, Xiangying, additional, Sridhar, Sainetra, additional, Santos, Katheryn, additional, Xiong, Kan, additional, Abramson, Vandana, additional, Patel, Ashka, additional, Cheng, Ju, additional, Brufsky, Adam M., additional, Rhoades, Justin, additional, Force, Jeremy, additional, Liu, Ruolin, additional, Traina, Tiffany A., additional, Carey, Lisa, additional, Rimawi, Mothaffar, additional, Elkhanany, Ahmed, additional, Stearns, Vered, additional, Specht, Jennifer M., additional, Burstein, Harold, additional, Wolff, Antonio C., additional, Winer, Eric, additional, Tayob, Nabihah, additional, Krop, Ian, additional, Golub, Todd, additional, Mayer, Erica L., additional, and Adalsteinsson, Viktor, additional

Published
2023
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9. Abstract OT2-01-07: evERA Breast Cancer: A phase III study of giredestrant (GDC-9545) + everolimus vs exemestane + everolimus in patients with estrogen receptor+, HER2– locally advanced or metastatic breast cancer

Author

Mayer, Erica L., primary, Tolaney, Sara, additional, Brufsky, Adam M., additional, Gradishar, William, additional, Jhaveri, Komal, additional, Martín, Miguel, additional, Moscetti, Luca, additional, Vidal, Gregory, additional, Cortazar, Patricia, additional, Feldman, Merilin, additional, Day, Bann-mo, additional, and Rugo, Hope, additional

Published
2023
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10. Abstract GS3-06: GS3-06 Palbociclib After CDK4/6i and Endocrine Therapy (PACE): A Randomized Phase II Study of Fulvestrant, Palbociclib, and Avelumab for Endocrine Pre-treated ER+/HER2- Metastatic Breast Cancer

Author

Mayer, Erica L., primary, Ren, Yue, additional, Wagle, Nikhil, additional, Mahtani, Reshma, additional, Ma, Cynthia, additional, DeMichele, Angela, additional, Cristofanilli, Massimo, additional, Meisel, Jane, additional, Miller, Kathy D., additional, Jolly, Trevor, additional, Riley, Elizabeth, additional, Qamar, Rubina, additional, Sharma, Priyanka, additional, Reid, Sonya, additional, Sinclair, Natalie, additional, Faggen, Meredith, additional, Block, Caroline, additional, Ko, Naomi, additional, Partridge, Ann, additional, Chen, Wendy Y., additional, DeMeo, Michelle K., additional, Attaya, Victoria, additional, Okpoebo, Amanda, additional, Liu, Yuan, additional, Gauthier, Eric, additional, Burstein, Harold, additional, Regan, Meredith, additional, and Tolaney, Sara, additional

Published
2023
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11. Abstract PD17-05: Development and Validation of a Composite Biomarker Predictive of Palbociclib + Endocrine Treatment Benefit in Early Breast Cancer: PENELOPE-B and PALLAS Trials

Author

Loibl, Sibylle, primary, Denkert, Carsten, additional, Liu, Yuan, additional, Knudsen, Erik S., additional, DeMichele, Angela, additional, Zhang, Zhe, additional, Teply-Szymanski, Julia, additional, Filipits, Martin, additional, Fasching, Peter A., additional, Gnant, Michael, additional, Deng, Shibing, additional, Balic, Marija, additional, Rojo, Federico, additional, Watson, Mark, additional, Deshpande, Chetan, additional, Turner, Nicholas, additional, Metzger, Otto, additional, Theall, Kathy Puyana, additional, Witkiewicz, Agnieszka, additional, Valota, Olga, additional, Symmans, W. Fraser, additional, and Mayer, Erica L., additional

Published
2023
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12. Mutational Signature 3 Detected from Clinical Panel Sequencing is Associated with Responses to Olaparib in Breast and Ovarian Cancers

Author

Batalini, Felipe, primary, Gulhan, Doga C., additional, Mao, Victor, additional, Tran, Antuan, additional, Polak, Madeline, additional, Xiong, Niya, additional, Tayob, Nabihah, additional, Tung, Nadine M., additional, Winer, Eric P., additional, Mayer, Erica L., additional, Knappskog, Stian, additional, Lønning, Per E., additional, Matulonis, Ursula A., additional, Konstantinopoulos, Panagiotis A., additional, Solit, David B., additional, Won, Helen, additional, Eikesdal, Hans P., additional, Park, Peter J., additional, and Wulf, Gerburg M., additional

Published
2022
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13. Abstract P4-09-01: Incidence of patient-reported fatigue developing in patients receiving palbociclib and endocrine therapy for advanced HR+ HER2- breast cancer

Author

Rahman, Shadab A, primary, Mayer, Erica L, additional, Poort, Hanneke, additional, Schrag, Deborah, additional, Tung, Stephanie C, additional, Zhou, Eric S, additional, Wiley, Aleta, additional, Finkelstein, Lauren, additional, Elguenaoui, Elkhansaa, additional, Nolan, Moira, additional, and Joffe, Hadine, additional

Published
2022
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14. Abstract P4-10-02: Patient-reported outcomes in EA1131: A randomized phase III trial of platinum vs. capecitabine in patients with residual triple-negative breast cancer after neoadjuvant chemotherapy

Author

Smith, Karen L, primary, Zhao, Fengmin, additional, Mayer, Ingrid A, additional, Tevaarwerk, Amye J, additional, Garcia, Sofia F, additional, Arteaga, Carlos L, additional, Symmans, William F, additional, Park, Ben H, additional, Burnette, Brian L, additional, Makower, Della F, additional, Block, Margaret, additional, Morley, Kimberly A, additional, Jani, Chirag R, additional, Mescher, Craig, additional, Dewani, Shabana J, additional, Brown-Glaberman, Ursa, additional, Flaum, Lisa E, additional, Mayer, Erica L, additional, Sikov, William M, additional, Rodler, Eve T, additional, DeMichele, Angela M, additional, Sparano, Joseph A, additional, Wolff, Antonio C, additional, Miller, Kathy D, additional, and Wagner, Lynne I, additional

Published
2022
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15. Phase 1b Clinical Trial with Alpelisib plus Olaparib for Patients with Advanced Triple-Negative Breast Cancer

Author

Batalini, Felipe, primary, Xiong, Niya, additional, Tayob, Nabihah, additional, Polak, Madeline, additional, Eismann, Julia, additional, Cantley, Lewis C., additional, Shapiro, Geoffrey I., additional, Adalsteinsson, Viktor, additional, Winer, Eric P., additional, Konstantinopoulos, Panagiotis A., additional, D'Andrea, Alan, additional, Swisher, Elizabeth M., additional, Matulonis, Ursula A., additional, Wulf, Gerburg M., additional, and Mayer, Erica L., additional

Published
2022
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17. Multidisciplinary Recommendations Regarding Post-Vaccine Adenopathy and Radiologic Imaging: Radiology Scientific Expert Panel

Author

Becker, Anton S., primary, Perez-Johnston, Rocio, additional, Chikarmane, Sona A., additional, Chen, Melissa M., additional, El Homsi, Maria, additional, Feigin, Kimberly N., additional, Gallagher, Katherine M., additional, Hanna, Ehab Y., additional, Hicks, Marshall, additional, Ilica, Ahmet T., additional, Mayer, Erica L., additional, Shinagare, Atul B., additional, Yeh, Randy, additional, Mayerhoefer, Marius E., additional, Hricak, Hedvig, additional, and Vargas, H. Alberto, additional

Published
2021
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18. Abstract 156: Mutational signature 3 predicts responses to olaparib plus buparlisib in triple-negative breast cancer and high-grade serous ovarian cancer

Author

Batalini, Felipe, primary, Gulhan, Doga, additional, Mao, Victor, additional, Polak, Madeline, additional, Winer, Eric P., additional, Mayer, Erica L., additional, Matulonis, Ursula A., additional, Konstantinopoulos, Panagiotis A., additional, Park, Peter, additional, and Wulf, Gerburg M., additional

Published
2021
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19. RASAL2 Confers Collateral MEK/EGFR Dependency in Chemoresistant Triple-Negative Breast Cancer

Author

Koh, Siang-Boon, primary, Ross, Kenneth, additional, Isakoff, Steven J., additional, Melkonjan, Nsan, additional, He, Lei, additional, Matissek, Karina J., additional, Schultz, Andrew, additional, Mayer, Erica L., additional, Traina, Tiffany A., additional, Carey, Lisa A., additional, Rugo, Hope S., additional, Liu, Minetta C., additional, Stearns, Vered, additional, Langenbucher, Adam, additional, Saladi, Srinivas Vinod, additional, Ramaswamy, Sridhar, additional, Lawrence, Michael S., additional, and Ellisen, Leif W., additional

Published
2021
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21. Sensitive Detection of Minimal Residual Disease in Patients Treated for Early-Stage Breast Cancer

Author

Parsons, Heather A., primary, Rhoades, Justin, additional, Reed, Sarah C., additional, Gydush, Gregory, additional, Ram, Priyanka, additional, Exman, Pedro, additional, Xiong, Kan, additional, Lo, Christopher C., additional, Li, Tianyu, additional, Fleharty, Mark, additional, Kirkner, Gregory J., additional, Rotem, Denisse, additional, Cohen, Ofir, additional, Yu, Fangyan, additional, Fitarelli-Kiehl, Mariana, additional, Leong, Ka Wai, additional, Hughes, Melissa E., additional, Rosenberg, Shoshana M., additional, Collins, Laura C., additional, Miller, Kathy D., additional, Blumenstiel, Brendan, additional, Trippa, Lorenzo, additional, Cibulskis, Carrie, additional, Neuberg, Donna S., additional, DeFelice, Matthew, additional, Freeman, Samuel S., additional, Lennon, Niall J., additional, Wagle, Nikhil, additional, Ha, Gavin, additional, Stover, Daniel G., additional, Choudhury, Atish D., additional, Getz, Gad, additional, Winer, Eric P., additional, Meyerson, Matthew, additional, Lin, Nancy U., additional, Krop, Ian, additional, Love, J. Christopher, additional, Makrigiorgos, G. Mike, additional, Partridge, Ann H., additional, Mayer, Erica L., additional, Golub, Todd R., additional, and Adalsteinsson, Viktor A., additional

Published
2020
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22. TBCRC 032 IB/II Multicenter Study: Molecular Insights to AR Antagonist and PI3K Inhibitor Efficacy in Patients with AR+ Metastatic Triple-Negative Breast Cancer

Author

Lehmann, Brian D., primary, Abramson, Vandana G., additional, Sanders, Melinda E., additional, Mayer, Erica L., additional, Haddad, Tufia C., additional, Nanda, Rita, additional, Van Poznak, Catherine, additional, Storniolo, Anna Maria, additional, Nangia, Julie R., additional, Gonzalez-Ericsson, Paula I., additional, Sanchez, Violeta, additional, Johnson, Kimberly N., additional, Abramson, Richard G., additional, Chen, Sheau-Chiann, additional, Shyr, Yu, additional, Arteaga, Carlos L., additional, Wolff, Antonio C., additional, and Pietenpol, Jennifer A., additional

Published
2020
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23. Abstract GS6-03: Cisplatin versus doxorubicin/cyclophosphamide as neoadjuvant treatment in germline BRCA mutation carriers (BRCA carriers) with HER2-negative breast cancer: Results from the INFORM trial (TBCRC 031)

Author

Tung, Nadine, primary, Arun, Banu, additional, Hofstatter, Erin, additional, Hacker, Michele R., additional, Toppmeyer, Deborah L., additional, Isakoff, Steven J., additional, Borges, Virginia, additional, Legare, Robert D., additional, Isaacs, Claudine, additional, Wolff, Antonio C., additional, Marcom, Paul K., additional, Mayer, Erica L., additional, Lange, Paulina B., additional, Goss, Andrew J., additional, Krop, Ian E., additional, Winer, Eric P., additional, Schnitt, Stuart J., additional, and Garber, Judy E., additional

Published
2020
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25. Multidisciplinary Recommendations Regarding Post-Vaccine Adenopathy and Radiologic Imaging: RadiologyScientific Expert Panel

Author

Becker, Anton S., Perez-Johnston, Rocio, Chikarmane, Sona A., Chen, Melissa M., Homsi, Maria El, Feigin, Kimberly N., Gallagher, Katherine M., Hanna, Ehab Y., Hicks, Marshall, Ilica, Ahmet T., Mayer, Erica L., Shinagare, Atul B., Yeh, Randy, Mayerhoefer, Marius E., Hricak, Hedvig, and Vargas, H. Alberto

Abstract

Adenopathy related to COVID-19 vaccination is a frequent imaging finding that may lead to a diagnostic conundrum in patients with manifest or suspected cancer, in whom it may be indistinguishable from malignant nodal involvement.

Published
2021
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26. Effect of the LIVESTRONG® at the YMCA exercise program on physical activity, fitness, quality of life and fatigue in cancer survivors

Author

Irwin, Melinda L., Cartmel, Brenda, Harrigan, Maura, Li, Fangyong, Sanft, Tara, Shockro, Laura, O’Connor, Keelin, Campbell, Nancy, Tolaney, Sara M., Mayer, Erica L., Yung, Rachel, Freedman, Rachel A., Partridge, Ann H., and Ligibel, Jennifer A.

Subjects
Male, Middle Aged, Article, Patient Outcome Assessment, Physical Fitness, Risk Factors, Case-Control Studies, Neoplasms, Population Surveillance, Body Composition, Quality of Life, Humans, Female, Self Report, Survivors, Exercise, Biomarkers, Fatigue, Aged
Abstract

Physical activity (PA) has been linked to a lower risk of developing and dying of cancer, yet many cancer survivors do not exercise. In the current study, the authors evaluated the impact of the LIVESTRONG at the YMCA exercise program, available at Young Men's Christian Associations (YMCAs) across the United States, on PA, fitness, quality of life, fatigue, body composition, serum biomarkers, and program safety in cancer survivors.Cancer survivors were recruited through the Yale Cancer Center and the Dana-Farber Cancer Institute and randomized to a 12-week, twice-weekly LIVESTRONG at the YMCA exercise program at YMCAs in Connecticut or Massachusetts or to a control group. Questionnaires, dual-energy x-ray absorptiometry scans, 6-minute walk tests (6MWTs), and a fasting blood draw were completed at baseline and at 12 weeks. Intervention effects were evaluated using mixed model repeated measures analysis, with changes at 12 weeks in PA and 6MWT as the primary endpoints.A total of 186 participants were randomized (95 to the exercise group and 91 to the control group). The majority of patients were diagnosed with AJCC stage I to II cancer and 53% had breast cancer. Participants randomized to the LIVESTRONG at the YMCA program experienced increases in PA (71% exercising at ≥ 150 minutes/week vs 26% of controls; P.05) and improvements in the 6MWT (group difference: 28.9 meters [95% confidence interval, 0.3-49.0; P = .004]) and quality of life (group difference: 2.6 [95% confidence interval, 0.1-5.0; P = .04]). No adverse events were reported.The LIVESTRONG at the YMCA exercise program has the potential to impact thousands of survivors across the YMCA network and could lead to improvements in disease and psychosocial outcomes in the growing population of cancer survivors. Cancer 2017;123:1249-1258. © 2016 American Cancer Society.

Published
2016

28. A Randomized Phase II Neoadjuvant Study of Cisplatin, Paclitaxel With or Without Everolimus in Patients with Stage II/III Triple-Negative Breast Cancer (TNBC): Responses and Long-term Outcome Correlated with Increased Frequency of DNA Damage Response Gene Mutations, TNBC Subtype, AR Status, and Ki67

Author

Jovanović, Bojana, primary, Mayer, Ingrid A., additional, Mayer, Erica L., additional, Abramson, Vandana G., additional, Bardia, Aditya, additional, Sanders, Melinda E., additional, Kuba, M. Gabriela, additional, Estrada, Monica V., additional, Beeler, J. Scott, additional, Shaver, Timothy M., additional, Johnson, Kimberly C., additional, Sanchez, Violeta, additional, Rosenbluth, Jennifer M., additional, Dillon, Patrick M., additional, Forero-Torres, Andres, additional, Chang, Jenny C., additional, Meszoely, Ingrid M., additional, Grau, Ana M., additional, Lehmann, Brian D., additional, Shyr, Yu, additional, Sheng, Quanhu, additional, Chen, Sheau-Chiann, additional, Arteaga, Carlos L., additional, and Pietenpol, Jennifer A., additional

Published
2017
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31. Council Clinical Perspective: Cardiovascular Health of Patients with Cancer and Cancer Survivors: A Roadmap to the Next Level

Author

Barac, Ana, Murtagh, Gillian, Carver, Joseph R., Chen, Ming Hui, Freeman, Andrew M., Herrmann, Joerg, Iliescu, Cezar, Ky, Bonnie, Mayer, Erica L., Okwuosa, Tochi M., Plana, Juan Carlos, Ryan, Thomas D., Rzeszut, Anne K., and Douglas, Pamela S.

Subjects
Cardiovascular Diseases, Data Collection, Neoplasms, Cardiology, Humans, Survivors, Medical Oncology, Article
Abstract

Many existing and emerging cancer therapies have a significant effect on the cardiovascular health of patients with cancer and cancer survivors. This paper examines current aspects of interdisciplinary cardio-oncology clinical care delivery and education in the United States and outlines how these data provide a platform for future development of the field. We present the results of the nationwide survey on cardio-oncology services, practices, and opinions, conducted among chiefs of cardiology and program directors, which demonstrate ranges of clinical activities and identify significant interest for increased educational opportunities and expert training of cardiovascular physicians in this field. The survey respondents recognized clinical relevance but emphasized lack of national guidelines, lack of funds, and limited awareness and infrastructure as the main challenges for development and growth of cardio-oncology. We discuss potential solutions to unmet needs through interdisciplinary collaboration and the active roles of professional societies and other stakeholders.

Published
2015

33. Cardiovascular Health of Patients With Cancer and Cancer Survivors

Author

Barac, Ana, primary, Murtagh, Gillian, additional, Carver, Joseph R., additional, Chen, Ming Hui, additional, Freeman, Andrew M., additional, Herrmann, Joerg, additional, Iliescu, Cezar, additional, Ky, Bonnie, additional, Mayer, Erica L., additional, Okwuosa, Tochi M., additional, Plana, Juan Carlos, additional, Ryan, Thomas D., additional, Rzeszut, Anne K., additional, and Douglas, Pamela S., additional

Published
2015
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34. Abstract P3-06-11: Homologous recombination deficiency (HRD) assay predicts response to cisplatin neoadjuvant chemotherapy in patients with triple negative breast cancer

Author

Richardson, Andrea L, primary, Silver, Daniel P, additional, Szallasi, Zoltan, additional, Birkbak, Nicolai J, additional, Wang, Zhigang C, additional, Iglehart, J Dirk, additional, Mayer, Erica L, additional, Winer, Eric P, additional, Tung, Nadine M, additional, Ryan, Paula D, additional, Isakoff, Steven J, additional, Barry, William T, additional, Greene-Collozi, April, additional, Gutin, Alexander, additional, Reid, Julia, additional, Neff, Chris, additional, Jones, Joshua, additional, Timms, Kirsten, additional, Hartman, Anne-Renee, additional, and Garber, Judy E, additional

Published
2015
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35. Circulating Tumor Cell Analysis in Metastatic Triple-Negative Breast Cancers

Author

Magbanua, Mark Jesus M., primary, Carey, Lisa A., additional, DeLuca, Amy, additional, Hwang, Jimmy, additional, Scott, Janet H., additional, Rimawi, Mothaffar F., additional, Mayer, Erica L., additional, Marcom, P. Kelly, additional, Liu, Minetta C., additional, Esteva, Francisco J., additional, Park, John W., additional, and Rugo, Hope S., additional

Published
2015
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36. Rosuvastatin Lowers Circulating Tissue Factor Antigen-Bearing Microparticles In Metastatic Breast Cancer: A Phase II, Multi-Dose, Randomized Trial (MicroSTAT Trial)

Author

Zwicker, Jeffrey I., primary, Mayer, Erica L., additional, Campigotto, Federico, additional, Geddings, Julia, additional, Christina, Herold, additional, Bowley, Sheryl, additional, Wulf, Gerburg, additional, Horowitz, Gary, additional, Neuberg, Donna S., additional, Mackman, Nigel, additional, and Furie, Bruce, additional

Published
2013
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43. Cardiovascular Health of Patients With Cancer and Cancer Survivors A Roadmap to the Next Level

Author

Barac, Ana, Murtagh, Gillian, Carver, Joseph R., Chen, Ming Hui, Freeman, Andrew M., Herrmann, Joerg, Iliescu, Cezar, Ky, Bonnie, Mayer, Erica L., Okwuosa, Tochi M., Plana, Juan Carlos, Ryan, Thomas D., Rzeszut, Anne K., and Douglas, Pamela S.

Subjects
cancer survivorship, cardiovascular toxicity, cardio-oncology, cardiotoxicity, cardiovascular risk prevention
Abstract

Many existing and emerging cancer therapies have a significant effect on the cardiovascular health of patients with cancer and cancer survivors. This paper examines current aspects of interdisciplinary cardio-oncology clinical care delivery and education in the United States and outlines how these data provide a platform for future development of the field. We present the results of the nationwide survey on cardio-oncology services, practices, and opinions, conducted among chiefs of cardiology and program directors, which demonstrate ranges of clinical activities and identify significant interest for increased educational opportunities and expert training of cardiovascular physicians in this field. The survey respondents recognized clinical relevance but emphasized lack of national guidelines, lack of funds, and limited awareness and infrastructure as the main challenges for development and growth of cardio-oncology. We discuss potential solutions to unmet needs through interdisciplinary collaboration and the active roles of professional societies and other stakeholders.

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44. Genomic profiling of ER+breast cancers after short-term estrogen suppression reveals alterations associated with endocrine resistance

Author

Nikhil Wagle, Weiyi Toy, Monica Rizzo, Eliezer M. Van Allen, Thomas Stricker, Jason Christiansen, Vincent A. Miller, Violeta Sanchez, Maria G. Kuba, Xinmeng J. Mu, Carlos L. Arteaga, Jennifer M. Giltnane, Erica L. Mayer, Ingrid M. Meszoely, Liping Du, Henry Gόmez, Kai Wang, Phillip J. Stephens, Monica V. Estrada, Paula Gonzalez Ericsson, Vandana G. Abramson, Kerry Fitzgerald, Danielle Murphy, Levi A. Garraway, Justin M. Balko, Mellissa J. Nixon, Luigi Formisano, Roman Yelensky, Yu Shyr, Ingrid A. Mayer, Melinda E. Sanders, Christian D. Young, Katherine E. Hutchinson, Jeffrey S. Ross, Sarat Chandarlapaty, Giltnane, Jennifer M., Hutchinson, Katherine E., Stricker, Thomas P., Formisano, Luigi, Young, Christian D., Estrada, Monica V., Nixon, Mellissa J., Du, Liping, Sanchez, Violeta, Ericsson, Paula Gonzalez, Kuba, Maria G., Sanders, Melinda E., Mu, Xinmeng J., Van Allen, Eliezer M., Wagle, Nikhil, Mayer, Ingrid A., Abramson, Vandana, Gómez, Henry, Rizzo, Monica, Toy, Weiyi, Chandarlapaty, Sarat, Mayer, Erica L., Christiansen, Jason, Murphy, Danielle, Fitzgerald, Kerry, Wang, Kai, Ross, Jeffrey S., Miller, Vincent A., Stephens, Phillip J., Yelensky, Roman, Garraway, Levi, Shyr, Yu, Meszoely, Ingrid, Balko, Justin M., and Arteaga, Carlos L.

Subjects
0301 basic medicine, medicine.medical_specialty, Aromatase inhibitor, biology, Cyclin-dependent kinase 4, medicine.drug_class, Letrozole, Oncology, drug resistance, Estrogen Receptor, Breast Cancer, General Medicine, Cell cycle, 03 medical and health sciences, 030104 developmental biology, Cyclin D1, Endocrinology, Estrogen, Internal medicine, biology.protein, medicine, Cancer research, Cyclin-dependent kinase 6, Estrogen receptor alpha, medicine.drug
Abstract

Inhibition of proliferation in estrogen receptor-positive (ER+) breast cancers after short-term antiestrogen therapy correlates with long-term patient outcome. We profiled 155 ER+/human epidermal growth factor receptor 2-negative (HER2-) early breast cancers from 143 patients treated with the aromatase inhibitor letrozole for 10 to 21 days before surgery. Twenty-one percent of tumors remained highly proliferative, suggesting that these tumors harbor alterations associated with intrinsic endocrine therapy resistance. Whole-exome sequencing revealed a correlation between 8p11-12 and 11q13 gene amplifications, including FGFR1 and CCND1, respectively, and high Ki67. We corroborated these findings in a separate cohort of serial pretreatment, postneoadjuvant chemotherapy, and recurrent ER+ tumors. Combined inhibition of FGFR1 and CDK4/6 reversed antiestrogen resistance in ER+FGFR1/CCND1 coamplified CAMA1 breast cancer cells. RNA sequencing of letrozole-treated tumors revealed the existence of intrachromosomal ESR1 fusion transcripts and increased expression of gene signatures indicative of enhanced E2F-mediated transcription and cell cycle processes in cancers with high Ki67. These data suggest that short-term preoperative estrogen deprivation followed by genomic profiling can be used to identify druggable alterations that may cause intrinsic endocrine therapy resistance.

Published
2017

45. Clonal hematopoiesis in older patients with breast cancer receiving chemotherapy.

Author

Mayerhofer C, Sedrak MS, Hopkins JO, Li T, Tayob N, Faggen MG, Sinclair NF, Chen WY, Parsons HA, Mayer EL, Lange PB, Basta AS, Perilla-Glen A, Lederman RI, Wong AR, Tiwari A, McAllister SS, Mittendorf EA, Gibson CJ, Burstein HJ, Kim AS, Freedman RA, and Miller PG

Subjects
Humans, Female, Aged, Retrospective Studies, Hematopoiesis genetics, Mutation, Clonal Hematopoiesis genetics, Breast Neoplasms drug therapy, Breast Neoplasms genetics
Abstract

Background: The expansion of hematopoietic stem cells carrying recurrent somatic mutations, termed clonal hematopoiesis (CH), is common in elderly individuals and is associated with increased risk of myeloid malignancy and all-cause mortality. Though chemotherapy is a known risk factor for developing CH, how myelosuppressive therapies affect the short-term dynamics of CH remains incompletely understood. Most studies have been limited by retrospective design, heterogeneous patient populations, varied techniques to identifying CH, and analysis of single timepoints., Methods: We examined serial samples from 40 older women with triple-negative or hormone receptor-positive breast cancer treated on the prospective ADjuVANt Chemotherapy in the Elderly trial to evaluate the prevalence and dynamics of CH at baseline and throughout chemotherapy (6 and 12 weeks)., Results: CH was detected in 44% of patients at baseline and in 53% at any timepoint. Baseline patient characteristics were not associated with CH. Over the course of treatment, mutations exhibited a variety of dynamics, including emergence, expansion, contraction, and disappearance. All mutations in TP53 (n = 3) and PPM1D (n = 4), genes that regulate the DNA damage response, either became detectable or expanded over the course of treatment. Neutropenia was more common in patients with CH, particularly when the mutations became detectable during treatment, and CH was significantly associated with cyclophosphamide dose reductions and holds (P = .02)., Conclusions: Our study shows that CH is common, dynamic, and of potential clinical significance in this population. Our results should stimulate larger efforts to understand the biological and clinical importance of CH in solid tumor malignancies., Trial Registration: ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03858322). Clinical trial registration number: NCT03858322., (© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Published
2023
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46. TBCRC 032 IB/II Multicenter Study: Molecular Insights to AR Antagonist and PI3K Inhibitor Efficacy in Patients with AR + Metastatic Triple-Negative Breast Cancer.

Author

Lehmann BD, Abramson VG, Sanders ME, Mayer EL, Haddad TC, Nanda R, Van Poznak C, Storniolo AM, Nangia JR, Gonzalez-Ericsson PI, Sanchez V, Johnson KN, Abramson RG, Chen SC, Shyr Y, Arteaga CL, Wolff AC, and Pietenpol JA

Subjects
Androgen Receptor Antagonists administration & dosage, Androgen Receptor Antagonists adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Benzamides, Class I Phosphatidylinositol 3-Kinases metabolism, Female, Humans, Imidazoles administration & dosage, Imidazoles adverse effects, Middle Aged, Neoplasm Metastasis, Nitriles, Oxazepines administration & dosage, Oxazepines adverse effects, Phenylthiohydantoin administration & dosage, Phenylthiohydantoin adverse effects, Phenylthiohydantoin analogs & derivatives, Protein Kinase Inhibitors administration & dosage, Protein Kinase Inhibitors adverse effects, Survival Rate, Triple Negative Breast Neoplasms metabolism, Triple Negative Breast Neoplasms pathology, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Class I Phosphatidylinositol 3-Kinases antagonists & inhibitors, Receptors, Androgen metabolism, Triple Negative Breast Neoplasms drug therapy
Abstract

Purpose: Preclinical data demonstrating androgen receptor (AR)-positive (AR + ) triple-negative breast cancer (TNBC) cells are sensitive to AR antagonists, and PI3K inhibition catalyzed an investigator-initiated, multi-institutional phase Ib/II study TBCRC032. The trial investigated the safety and efficacy of the AR-antagonist enzalutamide alone or in combination with the PI3K inhibitor taselisib in patients with metastatic AR + (≥10%) breast cancer., Patients and Methods: Phase Ib patients [estrogen receptor positive (ER + ) or TNBC] with AR + breast cancer received 160 mg enzalutamide in combination with taselisib to determine dose-limiting toxicities and the maximum tolerated dose (MTD). Phase II TNBC patients were randomized to receive either enzalutamide alone or in combination with 4 mg taselisib until disease progression. Primary endpoint was clinical benefit rate (CBR) at 16 weeks., Results: The combination was tolerated, and the MTD was not reached. The adverse events were hyperglycemia and skin rash. Overall, CBR for evaluable patients receiving the combination was 35.7%, and median progression-free survival (PFS) was 3.4 months. Luminal AR (LAR) TNBC subtype patients trended toward better response compared with non-LAR (75.0% vs. 12.5%, P = 0.06), and increased PFS (4.6 vs. 2.0 months, P = 0.082). Genomic analyses revealed subtype-specific treatment response, and novel FGFR2 fusions and AR splice variants., Conclusions: The combination of enzalutamide and taselisib increased CBR in TNBC patients with AR + tumors. Correlative analyses suggest AR protein expression alone is insufficient for identifying patients with AR-dependent tumors and knowledge of tumor LAR subtype and AR splice variants may identify patients more or less likely to benefit from AR antagonists., (©2019 American Association for Cancer Research.)

Published
2020
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