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1. Pre-treatment peripheral blood immunophenotyping and response to neoadjuvant chemotherapy in operable breast cancer

Author

Leon-Ferre, Roberto A., Whitaker, Kaitlyn R., Suman, Vera J., Hoskin, Tanya, Giridhar, Karthik V., Moore, Raymond M., Al-Jarrad, Ahmad, McLaughlin, Sarah A., Northfelt, Donald W., Hunt, Katie N., Conners, Amy Lynn, Moyer, Ann, Carter, Jodi M., Kalari, Krishna, Weinshilboum, Richard, Wang, Liewei, Ingle, James N., Knutson, Keith L., Ansell, Stephen M., Boughey, Judy C., Goetz, Matthew P., and Villasboas, Jose C.

Published
2024
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2. A phase II study of palbociclib plus letrozole plus trastuzumab as neoadjuvant treatment for clinical stages II and III ER+ HER2+ breast cancer (PALTAN)

Author

Ademuyiwa, Foluso O., Northfelt, Donald W., O’Connor, Tracey, Levine, Ellis, Luo, Jingqin, Tao, Yu, Hoog, Jeremy, Laury, Marie L., Summa, Tracy, Hammerschmidt, Trish, Guo, Zhanfang, Frith, Ashley, Weilbaecher, Katherine, Opyrchal, Mateusz, Aft, Rebecca, Clifton, Katherine, Suresh, Rama, Bagegni, Nusayba, Hagemann, Ian S., Iglesia, Michael D., and Ma, Cynthia X.

Published
2023
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4. Phase I study of liposomal irinotecan in patients with metastatic breast cancer: findings from the expansion phase

Author

Sachdev, Jasgit C, Munster, Pamela, Northfelt, Donald W, Han, Hyo Sook, Ma, Cynthia, Maxwell, Fiona, Wang, Tiffany, Belanger, Bruce, Zhang, Bin, Moore, Yan, Thiagalingam, Arunthathi, and Anders, Carey

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Cancer, Clinical Trials and Supportive Activities, Breast Cancer, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Adult, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Female, Humans, Irinotecan, Survival Rate, Treatment Outcome, Triple Negative Breast Neoplasms, Liposomal irinotecan, Metastatic breast cancer, Objective response rate, Phase I clinical trial, Brain metastases, Heavily pretreated patients, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposeMetastatic breast cancer (mBC) remains incurable and is associated with low survival rates. This study assessed the efficacy and safety of liposomal irinotecan in heavily pretreated patients with mBC, with or without active brain metastases (BM).MethodsFollowing the dose escalation phase and determination of recommended phase 2 dose, the expansion phase of this phase I, open-label, non-randomized study, assigned adult women to cohorts based on mBC subtype: cohort 1, hormone receptor +/human epidermal growth factor receptor 2-; cohort 2, triple-negative breast cancer; or cohort 3, any mBC subtype with active BM. Patients received liposomal irinotecan 50 or 70 mg/m2 free base every 2 weeks. Here, we report secondary outcomes including best overall response (BOR), objective response rate (ORR), and treatment-emergent adverse events (TEAEs).ResultsFor non-central nervous system (non-CNS) disease across all cohorts (intent-to-treat population, N = 29), the ORR was 34.5% (95% confidence interval: 17.94-54.33), with a BOR of partial response in 10 patients (34.5%), stable disease in five (17.2%), progressive disease in 10 (34.5%); four patients were unevaluable (13.8%). The ORR for the CNS cohort was 30.0% (95% confidence interval: 6.67-65.25) using modified Response Evaluation Criteria in Solid Tumors. Common grade 3 or higher TEAEs were diarrhea (27.6%), nausea (17.2%), fatigue (13.8%), asthenia (10.3%), and hypokalemia (10.3%). Serious treatment-related TEAEs were reported in six patients (20.7%). No treatment-related TEAEs resulted in death.ConclusionsLiposomal irinotecan monotherapy demonstrated antitumor activity in heavily pretreated patients with mBC, with or without BM. The observed safety profile was consistent with that in previous studies.Clinical trial registrationTrial registration ID NCT01770353.

Published
2021

5. MK-2206 and Standard Neoadjuvant Chemotherapy Improves Response in Patients With Human Epidermal Growth Factor Receptor 2-Positive and/or Hormone Receptor-Negative Breast Cancers in the I-SPY 2 Trial.

Author

Chien, A Jo, Tripathy, Debasish, Albain, Kathy S, Symmans, W Fraser, Rugo, Hope S, Melisko, Michelle E, Wallace, Anne M, Schwab, Richard, Helsten, Teresa, Forero-Torres, Andres, Stringer-Reasor, Erica, Ellis, Erin D, Kaplan, Henry G, Nanda, Rita, Jaskowiak, Nora, Murthy, Rashmi, Godellas, Constantine, Boughey, Judy C, Elias, Anthony D, Haley, Barbara B, Kemmer, Kathleen, Isaacs, Claudine, Clark, Amy S, Lang, Julie E, Lu, Janice, Korde, Larissa, Edmiston, Kirsten K, Northfelt, Donald W, Viscusi, Rebecca K, Yee, Douglas, Perlmutter, Jane, Hylton, Nola M, Van't Veer, Laura J, DeMichele, Angela, Wilson, Amy, Peterson, Garry, Buxton, Meredith B, Paoloni, Melissa, Clennell, Julia, Berry, Scott, Matthews, Jeffrey B, Steeg, Katherine, Singhrao, Ruby, Hirst, Gillian L, Sanil, Ashish, Yau, Christina, Asare, Smita M, Berry, Donald A, and Esserman, Laura J

Subjects
Clinical Research, Clinical Trials and Supportive Activities, Cancer, Prevention, Breast Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Doxorubicin, Female, Heterocyclic Compounds, 3-Ring, Humans, Middle Aged, Neoadjuvant Therapy, Paclitaxel, Protein Kinase Inhibitors, Proto-Oncogene Proteins c-akt, Receptor, ErbB-2, Receptors, Steroid, Trastuzumab, I-SPY 2 Consortium, Receptor, erbB-2, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeThe phosphatidylinositol 3-kinase/Akt/mammalian target of rapamycin is a key pathway of survival and therapeutic resistance in breast cancer. We evaluated the pan-Akt inhibitor MK-2206 in combination with standard therapy in patients with high-risk early-stage breast cancer.Patients and methodsI-SPY 2 is a multicenter, phase II, open-label, adaptively randomized neoadjuvant platform trial that screens experimental therapies and efficiently identifies potential predictive biomarker signatures. Patients are categorized by human epidermal growth factor receptor 2 (HER2), hormone receptor (HR), and MammaPrint statuses in a 2 × 2 × 2 layout. Patients within each of these 8 biomarker subtypes are adaptively randomly assigned to one of several experimental therapies, including MK-2206, or control. Therapies are evaluated for 10 biomarker signatures, each of which is a combination of these subtypes. The primary end point is pathologic complete response (pCR). A therapy graduates with one or more of these signatures if and when it has an 85% Bayesian predictive probability of success in a hypothetical phase III trial, adjusting for biomarker covariates. Patients in the current report received standard taxane- and anthracycline-based neoadjuvant therapy without (control) or with oral MK-2206 135 mg/week.ResultsMK-2206 graduated with 94 patients and 57 concurrently randomly assigned controls in 3 graduation signatures: HR-negative/HER2-positive, HR-negative, and HER2-positive. Respective Bayesian mean covariate-adjusted pCR rates and percentage probability that MK-2206 is superior to control were 0.48:0.29 (97%), 0.62:0.36 (99%), and 0.46:0.26 (94%). In exploratory analyses, MK-2206 evinced a numerical improvement in event-free survival in its graduating signatures. The most significant grade 3-4 toxicity was rash (14% maculopapular, 8.6% acneiform).ConclusionThe Akt inhibitor MK-2206 combined with standard neoadjuvant therapy resulted in higher estimated pCR rates in HR-negative and HER2-positive breast cancer. Although MK-2206 is not being further developed at this time, this class of agents remains of clinical interest.

Published
2020

7. A randomized phase 2 study of neoadjuvant carboplatin and paclitaxel with or without atezolizumab in triple negative breast cancer (TNBC) - NCI 10013

Author

Ademuyiwa, Foluso O., Gao, Feng, Street, Cherease R., Chen, Ina, Northfelt, Donald W., Wesolowski, Robert, Arora, Mili, Brufsky, Adam, Dees, E. Claire, Santa-Maria, Cesar A., Connolly, Roisin M., Force, Jeremy, Moreno-Aspitia, Alvaro, Herndon, John M., Carmody, Madelyn, Davies, Sherri R., Larson, Sarah, Pfaff, Kathleen L., Jones, Stephanie M., Weirather, Jason L., Giobbie-Hurder, Anita, Rodig, Scott J., Liu, Zheng, Hagemann, Ian S., Sharon, Elad, and Gillanders, William E.

Published
2022
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8. Adaptive Randomization of Neratinib in Early Breast Cancer

Author

Park, John W, Liu, Minetta C, Yee, Douglas, Yau, Christina, van 't Veer, Laura J, Symmans, W Fraser, Paoloni, Melissa, Perlmutter, Jane, Hylton, Nola M, Hogarth, Michael, DeMichele, Angela, Buxton, Meredith B, Chien, A Jo, Wallace, Anne M, Boughey, Judy C, Haddad, Tufia C, Chui, Stephen Y, Kemmer, Kathleen A, Kaplan, Henry G, Isaacs, Claudine, Nanda, Rita, Tripathy, Debasish, Albain, Kathy S, Edmiston, Kirsten K, Elias, Anthony D, Northfelt, Donald W, Pusztai, Lajos, Moulder, Stacy L, Lang, Julie E, Viscusi, Rebecca K, Euhus, David M, Haley, Barbara B, Khan, Qamar J, Wood, William C, Melisko, Michelle, Schwab, Richard, Helsten, Teresa, Lyandres, Julia, Davis, Sarah E, Hirst, Gillian L, Sanil, Ashish, Esserman, Laura J, and Berry, Donald A

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Breast Cancer, Clinical Research, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Bayes Theorem, Biomarkers, Tumor, Breast Neoplasms, Female, Humans, Middle Aged, Neoadjuvant Therapy, Paclitaxel, Quinolines, Receptor, ErbB-2, Receptors, Estrogen, Receptors, Progesterone, Trastuzumab, I-SPY 2 Investigators, Receptor, erbB-2, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundThe heterogeneity of breast cancer makes identifying effective therapies challenging. The I-SPY 2 trial, a multicenter, adaptive phase 2 trial of neoadjuvant therapy for high-risk clinical stage II or III breast cancer, evaluated multiple new agents added to standard chemotherapy to assess the effects on rates of pathological complete response (i.e., absence of residual cancer in the breast or lymph nodes at the time of surgery).MethodsWe used adaptive randomization to compare standard neoadjuvant chemotherapy plus the tyrosine kinase inhibitor neratinib with control. Eligible women were categorized according to eight biomarker subtypes on the basis of human epidermal growth factor receptor 2 (HER2) status, hormone-receptor status, and risk according to a 70-gene profile. Neratinib was evaluated against control with regard to 10 biomarker signatures (prospectively defined combinations of subtypes). The primary end point was pathological complete response. Volume changes on serial magnetic resonance imaging were used to assess the likelihood of such a response in each patient. Adaptive assignment to experimental groups within each disease subtype was based on Bayesian probabilities of the superiority of the treatment over control. Enrollment in the experimental group was stopped when the 85% Bayesian predictive probability of success in a confirmatory phase 3 trial of neoadjuvant therapy reached a prespecified threshold for any biomarker signature ("graduation"). Enrollment was stopped for futility if the probability fell to below 10% for every biomarker signature.ResultsNeratinib reached the prespecified efficacy threshold with regard to the HER2-positive, hormone-receptor-negative signature. Among patients with HER2-positive, hormone-receptor-negative cancer, the mean estimated rate of pathological complete response was 56% (95% Bayesian probability interval [PI], 37 to 73%) among 115 patients in the neratinib group, as compared with 33% among 78 controls (95% PI, 11 to 54%). The final predictive probability of success in phase 3 testing was 79%.ConclusionsNeratinib added to standard therapy was highly likely to result in higher rates of pathological complete response than standard chemotherapy with trastuzumab among patients with HER2-positive, hormone-receptor-negative breast cancer. (Funded by QuantumLeap Healthcare Collaborative and others; I-SPY 2 TRIAL ClinicalTrials.gov number, NCT01042379.).

Published
2016

9. Adaptive Randomization of Veliparib–Carboplatin Treatment in Breast Cancer

Author

Rugo, Hope S, Olopade, Olufunmilayo I, DeMichele, Angela, Yau, Christina, van 't Veer, Laura J, Buxton, Meredith B, Hogarth, Michael, Hylton, Nola M, Paoloni, Melissa, Perlmutter, Jane, Symmans, W Fraser, Yee, Douglas, Chien, A Jo, Wallace, Anne M, Kaplan, Henry G, Boughey, Judy C, Haddad, Tufia C, Albain, Kathy S, Liu, Minetta C, Isaacs, Claudine, Khan, Qamar J, Lang, Julie E, Viscusi, Rebecca K, Pusztai, Lajos, Moulder, Stacy L, Chui, Stephen Y, Kemmer, Kathleen A, Elias, Anthony D, Edmiston, Kirsten K, Euhus, David M, Haley, Barbara B, Nanda, Rita, Northfelt, Donald W, Tripathy, Debasish, Wood, William C, Ewing, Cheryl, Schwab, Richard, Lyandres, Julia, Davis, Sarah E, Hirst, Gillian L, Sanil, Ashish, Berry, Donald A, and Esserman, Laura J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Genetics, Breast Cancer, Clinical Research, Cancer, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Bayes Theorem, Benzimidazoles, Carboplatin, Female, Humans, Middle Aged, Neoadjuvant Therapy, Paclitaxel, Poly(ADP-ribose) Polymerase Inhibitors, Triple Negative Breast Neoplasms, I-SPY 2 Investigators, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundThe genetic and clinical heterogeneity of breast cancer makes the identification of effective therapies challenging. We designed I-SPY 2, a phase 2, multicenter, adaptively randomized trial to screen multiple experimental regimens in combination with standard neoadjuvant chemotherapy for breast cancer. The goal is to match experimental regimens with responding cancer subtypes. We report results for veliparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, combined with carboplatin.MethodsIn this ongoing trial, women are eligible for participation if they have stage II or III breast cancer with a tumor 2.5 cm or larger in diameter; cancers are categorized into eight biomarker subtypes on the basis of status with regard to human epidermal growth factor receptor 2 (HER2), hormone receptors, and a 70-gene assay. Patients undergo adaptive randomization within each biomarker subtype to receive regimens that have better performance than the standard therapy. Regimens are evaluated within 10 biomarker signatures (i.e., prospectively defined combinations of biomarker subtypes). Veliparib-carboplatin plus standard therapy was considered for HER2-negative tumors and was therefore evaluated in 3 signatures. The primary end point is pathological complete response. Tumor volume changes measured by magnetic resonance imaging during treatment are used to predict whether a patient will have a pathological complete response. Regimens move on from phase 2 if and when they have a high Bayesian predictive probability of success in a subsequent phase 3 neoadjuvant trial within the biomarker signature in which they performed well.ResultsWith regard to triple-negative breast cancer, veliparib-carboplatin had an 88% predicted probability of success in a phase 3 trial. A total of 72 patients were randomly assigned to receive veliparib-carboplatin, and 44 patients were concurrently assigned to receive control therapy; at the completion of chemotherapy, the estimated rates of pathological complete response in the triple-negative population were 51% (95% Bayesian probability interval [PI], 36 to 66%) in the veliparib-carboplatin group versus 26% (95% PI, 9 to 43%) in the control group. The toxicity of veliparib-carboplatin was greater than that of the control.ConclusionsThe process used in our trial showed that veliparib-carboplatin added to standard therapy resulted in higher rates of pathological complete response than standard therapy alone specifically in triple-negative breast cancer. (Funded by the QuantumLeap Healthcare Collaborative and others; I-SPY 2 TRIAL ClinicalTrials.gov number, NCT01042379.).

Published
2016

10. Race, Gene Expression Signatures, and Clinical Outcomes of Patients With High-Risk Early Breast Cancer

Author

Kyalwazi, Beverly, primary, Yau, Christina, additional, Campbell, Michael J., additional, Yoshimatsu, Toshio F., additional, Chien, A. Jo, additional, Wallace, Anne M., additional, Forero-Torres, Andres, additional, Pusztai, Lajos, additional, Ellis, Erin D., additional, Albain, Kathy S., additional, Blaes, Anne H., additional, Haley, Barbara B., additional, Boughey, Judy C., additional, Elias, Anthony D., additional, Clark, Amy S., additional, Isaacs, Claudine J., additional, Nanda, Rita, additional, Han, Hyo S., additional, Yung, Rachel L., additional, Tripathy, Debasish, additional, Edmiston, Kristen K., additional, Viscusi, Rebecca K., additional, Northfelt, Donald W., additional, Khan, Qamar J., additional, Asare, Smita M., additional, Wilson, Amy, additional, Hirst, Gillian L., additional, Lu, Ruixiao, additional, Symmans, William Fraser, additional, Yee, Douglas, additional, DeMichele, Angela M., additional, van ’t Veer, Laura J., additional, Esserman, Laura J., additional, and Olopade, Olufunmilayo I., additional

Published
2023
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11. Correction to: Establishing and characterizing patient-derived xenografts using pre-chemotherapy percutaneous biopsy and post-chemotherapy surgical samples from a prospective neoadjuvant breast cancer study

Author

Yu, Jia, Qin, Bo, Moyer, Ann M., Sinnwell, Jason P., Thompson, Kevin J., Copland, III, John A., Marlow, Laura A., Miller, James L., Yin, Ping, Gao, Bowen, Minter-Dykhouse, Katherine, Tang, Xiaojia, McLaughlin, Sarah A., Moreno-Aspitia, Alvaro, Schweitzer, Anthony, Lu, Yan, Hubbard, Jason, Northfelt, Donald W., Gray, Richard J., Hunt, Katie, Conners, Amy L., Suman, Vera J., Kalari, Krishna R., Ingle, James N., Lou, Zhenkun, Visscher, Daniel W., Weinshilboum, Richard, Boughey, Judy C., Goetz, Matthew P., and Wang, Liewei

Published
2021
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12. Abstract 1921: Universal genetic testing for hereditary cancer syndromes in an under-represented minority population

Author

Khadarian, Kevork A., primary, Pisipati, Sailaja, additional, Jones, Jeremy C., additional, Colon-Otero, Gerardo, additional, Northfelt, Donald W., additional, Gary, Lindsey, additional, Ekpoh, Idara U., additional, Moreno, Giovanna G., additional, Esplin, Edward D., additional, Nussbaum, Robert, additional, Heald, Brandie, additional, Klint, Margaret A., additional, Barrus, Kathleen A., additional, Bekaii-Saab, Tanios S., additional, Sekulic, Aleksandar, additional, Golafshar, Michael A., additional, Kunze, Katie L., additional, Willman, Cheryl L., additional, Lazaridis, Konstantinos N., additional, and Samadder, Niloy Jewel, additional

Published
2023
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13. A Phase I/II Study of Bortezomib in Combination with Paclitaxel, Carboplatin, and Concurrent Thoracic Radiation Therapy for Non–Small-Cell Lung Cancer: North Central Cancer Treatment Group (NCCTG)-N0321

Author

Zhao, Yujie, Foster, Nathan R., Meyers, Jeffrey P., Thomas, Sachdev P., Northfelt, Donald W., Rowland, Kendrith M., Jr, Mattar, Bassam I., Johnson, David B., Molina, Julian R., Mandrekar, Sumithra J., Schild, Steven E., Bearden, James D., III, Aubry, Marie-Christine, and Adjei, Alex A.

Published
2015
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14. Additional file 1 of Integration of multiomics data shows down regulation of mismatch repair and tubulin pathways in triple-negative chemotherapy-resistant breast tumors

Author

Tang, Xiaojia, Thompson, Kevin J., Kalari, Krishna R., Sinnwell, Jason P., Suman, Vera J., Vedell, Peter T., McLaughlin, Sarah A., Northfelt, Donald W., Aspitia, Alvaro Moreno, Gray, Richard J., Carter, Jodi M., Weinshilboum, Richard, Wang, Liewei, Boughey, Judy C., and Goetz, Matthew P.

Abstract

Additional file 1. Supplementary figures.

Published
2023
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15. Establishing and characterizing patient-derived xenografts using pre-chemotherapy percutaneous biopsy and post-chemotherapy surgical samples from a prospective neoadjuvant breast cancer study

Author

Yu, Jia, Qin, Bo, Moyer, Ann M., Sinnwell, Jason P., Thompson, Kevin J., Copland, III, John A., Marlow, Laura A., Miller, James L., Yin, Ping, Gao, Bowen, Minter-Dykhouse, Katherine, Tang, Xiaojia, McLaughlin, Sarah A., Moreno-Aspitia, Alvaro, Schweitzer, Anthony, Lu, Yan, Hubbard, Jason, Northfelt, Donald W., Gray, Richard J., Hunt, Katie, Conners, Amy L., Suman, Vera J., Kalari, Krishna R., Ingle, James N., Lou, Zhenkun, Visscher, Daniel W., Weinshilboum, Richard, Boughey, Judy C., Goetz, Matthew P., and Wang, Liewei

Published
2017
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16. Quality of Life Following Receipt of Adjuvant Chemotherapy With and Without Bevacizumab in Patients With Lymph Node–Positive and High-Risk Lymph Node–Negative Breast Cancer

Author

Rosenberg, Shoshana M., primary, O’Neill, Anne, additional, Sepucha, Karen, additional, Miller, Kathy D., additional, Dang, Chau T., additional, Northfelt, Donald W., additional, Sledge, George W., additional, Schneider, Bryan P., additional, and Partridge, Ann H., additional

Published
2022
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17. Abstract P4-01-05: Multi-omics data shows downregulation of mismatch repair, purin and tublin pathways in AR-negative triple-negative chemotherapy-resistant tumors

Author

Kalari, Krishna R, primary, Suman, Vera J, additional, Tang, Xiaojia, additional, Sinnwell, Jason P, additional, Thompson, Kevin J, additional, Vedell, Peter T, additional, Carter, Jodi M, additional, McLaughlin, Sarah A, additional, Aspitia, Alvaro Moreno, additional, Northfelt, Donald W, additional, Gray, Richard J, additional, Weinshilboum, Richard, additional, Wang, Liewei, additional, Boughey, Judy C, additional, and Goetz, Matthew, additional

Published
2022
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18. Abstract P5-01-07: Patient-derived xenografts (PDXs) generated from hormone receptor-positive breast cancer (BC) before and after cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) treatment: Initial findings from the PROMISE study

Author

Yu, Jia, primary, Suman, Vera J., additional, He, Jun, additional, Sinnwell, Jason P., additional, Moyer, Ann M., additional, Qin, Bo, additional, Gu, Yayun, additional, Zhang, Huan, additional, Carter, Jodi M., additional, Kalari, Krishna R., additional, McMenomy, Brendan P., additional, Liu, Minetta C., additional, Haddad, Tufia C., additional, Ruddy, Kathryn J., additional, Couch, Fergus J., additional, Moreno-Aspitia, Alvaro, additional, Northfelt, Donald W., additional, Weinshilboum, Richard, additional, O'Sullivan, Ciara, additional, Goetz, Matthew P., additional, and Wang, Liewei, additional

Published
2022
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19. Abstract P4-01-03: Multiomics data reveal novel biomarkers for CDK4/6 resistance

Author

Kalari, Krishna R., primary, Thompson, Kevin J., additional, Sinnwell, Jason, additional, Tang, Xiaojia, additional, Suman, Vera J., additional, He, Jun, additional, Byeon, Seul Kee, additional, Pandey, Akhilesh, additional, Casey, Abe Eyman, additional, Vedell, Peter T., additional, Moyer, Ann M., additional, Moreno-Aspitia, Alvaro, additional, Northfelt, Donald W., additional, Liu, Minetta C., additional, Haddad, Tufia C., additional, Chumsri, Saranya, additional, Peethambaram, Prema, additional, Ruddy, Kathryn J., additional, Giridhar, Karthik V., additional, Leon-Ferre, Roberto A., additional, Weinshilboum, Richard M., additional, Wang, Liewei, additional, O’ Sullivan, Ciara C., additional, and Goetz, Matthew P., additional

Published
2022
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20. Abstract P5-13-22: Serum thymidine kinase 1 activity (TKa) levels and progression-free survival (PFS) in patients (pts) with hormone receptor positive (HR+) HER2-negative metastatic breast cancer (MBC) on palbociclib (Pb) and endocrine therapy (ET)

Author

O'Sullivan, Ciara C, primary, He, Jun, additional, Sinnwell, Jason, additional, Suman, Vera J, additional, Kalari, Krishna R, additional, Vedell, Peter T, additional, Moyer, Ann M, additional, Tang, Xiaojia, additional, Thompson, Kevin J, additional, Casey, Abe Eyman, additional, Moreno-Aspitia, Alvaro, additional, Northfelt, Donald W, additional, Liu, Minetta C, additional, Haddad, Tufia C, additional, Chumsri, Saranya, additional, McMenomy, Brendan, additional, Peethambaram, Prema, additional, Ruddy, Kathryn J, additional, Giridhar, Karthik V, additional, Leon-Ferre, Roberto A, additional, Bergqvist, Mattias, additional, Nordmark, Adrian, additional, Weinshilboum, Richard M, additional, Wang, Liewei, additional, and Goetz, Matthew P, additional

Published
2022
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21. Multi‐omic molecular profiling guide’s efficacious treatment selection in refractory metastatic breast cancer: a prospective phase II clinical trial

Author

Pierobon, Mariaelena, primary, Robert, Nicholas J., additional, Northfelt, Donald W., additional, Jahanzeb, Mohammad, additional, Wong, Shukmei, additional, Hodge, Kimberly A., additional, Baldelli, Elisa, additional, Aldrich, Jessica, additional, Craig, David W., additional, Liotta, Lance A., additional, Avramovic, Sanja, additional, Wojtusiak, Janusz, additional, Alemi, Farrokh, additional, Wulfkuhle, Julia D., additional, Bellos, Angela, additional, Gallagher, Rosa I., additional, Arguello, David, additional, Conrad, Amber, additional, Kemkes, Ariane, additional, Loesch, David M., additional, Vocila, Linda, additional, Dunetz, Bryant, additional, Carpten, John D., additional, Petricoin, Emanuel F., additional, and Anthony, Stephen P., additional

Published
2021
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22. Patient-Derived Xenograft Engraftment and Breast Cancer Outcomes in a Prospective Neoadjuvant Study (BEAUTY)

Author

Boughey, Judy C., primary, Suman, Vera J., additional, Yu, Jia, additional, Santo, Katelyn, additional, Sinnwell, Jason P., additional, Carter, Jodi M., additional, Kalari, Krishna R., additional, Tang, Xiaojia, additional, McLaughlin, Sarah A., additional, Moreno-Aspitia, Alvaro, additional, Northfelt, Donald W., additional, Gray, Richard J., additional, Hunt, Katie N., additional, Conners, Amy Lynn, additional, Ingle, James N., additional, Moyer, Ann, additional, Weinshilboum, Richard, additional, Copland, John A., additional, Wang, Liewei, additional, and Goetz, Matthew P., additional

Published
2021
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24. Trastuzumab-induced cardiotoxicity: heart failure at the crossroads

Author

Sengupta, Partho P., Northfelt, Donald W., Gentile, Federico, Zamorano, Jose L., and Khandheria, Bijoy K.

Subjects
Heart failure -- Risk factors, Drugs -- Health aspects, Drugs -- Reports, Drugs -- Risk factors
Abstract

Trastuzumab, a drug targeting human epidermal growth factor receptor 2, improves survival rate in women with metastatic breast cancer. Symptomatic heart failure, a serious adverse effect of trastuzumab, occurs in [...]

Published
2008

25. Abstract PD7-05: Neoadjuvant chemotherapy selectively alters spatially-defined immune landscapes in clinical luminal B HR+/HER2- breast cancers: Analysis of the breast cancer genome guided therapy study (BEAUTY)

Author

Carter, Jodi M, primary, Boughey, Judy C, additional, He, Jun, additional, Suman, Vera J, additional, Wang, Xue, additional, Kachergus, Jennifer M, additional, Kalari, Krishna R, additional, Wang, Liewei, additional, Weinshilboum, Richard, additional, Moyer, Ann M, additional, McLaughlin, Sarah A, additional, Moreno-Aspitia, Alvaro, additional, Northfelt, Donald W, additional, Gray, Richard J, additional, Ingle, James N, additional, Thompson, E. Aubrey, additional, and Goetz, Matthew P, additional

Published
2021
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26. Abstract PD7-04: Association between patient derived xenograft (PDX) take rate and breast cancer recurrence in the prospective breast cancer genome guided therapy study (BEAUTY)

Author

Boughey, Judy C., primary, Suman, Vera J., additional, Yu, Jia, additional, Santo, Katelyn, additional, Sinnwell, Jason P., additional, Carter, Jodi M., additional, Kalari, Krishna R., additional, Tang, Xiaojia, additional, McLaughlin, Sarah A., additional, Aspitia, Alvaro Moreno, additional, Copland, John A., additional, Northfelt, Donald W., additional, Gray, Richard J., additional, Hunt, Katie N., additional, Conners, Amy Lynn, additional, Weinshilboum, Richard, additional, Wang, Liewei, additional, and Goetz, Matthew P., additional

Published
2021
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27. Abstract PD10-05: Universal genetic testing in breast cancer patients: A multi-center prospective study

Author

Ernst, Brenda, primary, Ertz-Archambault, Natalie, additional, Rhodes, Deborah J, additional, Northfelt, Donald W, additional, Wick, Myra, additional, Riegert-Johnson, Douglas L, additional, Okuno, Scott, additional, Kunze, Katie, additional, Golafshar, Michael, additional, Azevedo, Cindy M, additional, Junior, PLS Uson, additional, Esplin, ED, additional, Nussbaum, Robert, additional, Klint, Margaret, additional, Mantia, Sarah, additional, Hager, Megan, additional, Stewart, Keith, additional, and Samadder, Niloy Jewel, additional

Published
2021
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28. Abstract PS5-24: Novel genomic variants and pathways associated with baseline serum thymidine kinase 1 levels in HR-positive HER2-negative MBC patients commencing palbociclib and letrozole

Author

Sullivan, Ciara C O, primary, Kalari, Krishna R, additional, Suman, Vera J, additional, Vedell, Peter T, additional, Moyer, Ann, additional, Casey, Abraham D Eyman, additional, Sinnwell, Jason, additional, Tang, Xiaojia, additional, Thompson, Kevin, additional, Moreno-Aspitia, Alvaro, additional, Northfelt, Donald W, additional, Liu, Minetta C, additional, Haddad, Tufia C, additional, Chumsri, Saranya, additional, Peethambaram, Prema, additional, Ruddy, Kathryn J, additional, Giridhar, Karthik V, additional, Leon-Ferre, Roberto A, additional, Nordmark, Adrian, additional, Bergqvist, Mattias, additional, McMenomy, Brendan P, additional, Weinshilboum, Richard M, additional, Wang, Liewei, additional, and Goetz, Matthew P, additional

Published
2021
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29. Abstract PD14-09: Nci 10013 - A randomized phase 2 study of neoadjuvant carboplatin and paclitaxel, with or without atezolizumab in triple negative breast cancer (TNBC)

Author

Ademuyiwa, Foluso O, primary, Gao, Feng, additional, Chen, Ina, additional, Northfelt, Donald W, additional, Wesolowski, Robert, additional, Arora, Mili, additional, Brufsky, Adam, additional, Dees, Claire, additional, Santa-Maria, Cesar A, additional, Connolly, Roisin M, additional, Force, Jeremy, additional, Moreno-Aspitia, Alvaro, additional, Larson, Sarah, additional, Sharon, Elad, additional, and Gillanders, William, additional

Published
2021
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31. TSPYL5 SNPs: Association with Plasma Estradiol Concentrations and Aromatase Expression

Author

Liu, Mohan, Ingle, James N., Fridley, Brooke L., Buzdar, Aman U., Robson, Mark E., Kubo, Michiaki, Wang, Liewei, Batzler, Anthony, Jenkins, Gregory D., Pietrzak, Tracy L., Carlson, Erin E., Goetz, Matthew P., Northfelt, Donald W., Perez, Edith A., Williard, Clark V., Schaid, Daniel J., Nakamura, Yusuke, and Weinshilboum, Richard M.

Published
2013

36. Treatment of AIDS-related cutaneous Kaposi's sarcoma with topical alitretinoin (9-cis-retinoic acid) gel

Author

Walmsley, Sharon, Northfelt, Donald W., Melosky, Barbara, Conant, Marcus, Friedman-Kien, Alvin E., and Wagner, Bridget

Subjects
Kaposi's sarcoma -- Drug therapy, AIDS (Disease) -- Complications, Retinoids -- Health aspects, Health
Abstract

The drug alitretinoin appears to be effective in treating a complication of AIDS called Kaposi's sarcoma, according to a study of 268 AIDS patients. This drug is a form of retinoic acid, which is effective in treating many other skin diseases.

Published
1999

37. Multi‐omic molecular profiling guide's efficacious treatment selection in refractory metastatic breast cancer: a prospective phase II clinical trial.

Author

Pierobon, Mariaelena, Robert, Nicholas J., Northfelt, Donald W., Jahanzeb, Mohammad, Wong, Shukmei, Hodge, Kimberly A., Baldelli, Elisa, Aldrich, Jessica, Craig, David W., Liotta, Lance A., Avramovic, Sanja, Wojtusiak, Janusz, Alemi, Farrokh, Wulfkuhle, Julia D., Bellos, Angela, Gallagher, Rosa I., Arguello, David, Conrad, Amber, Kemkes, Ariane, and Loesch, David M.

Abstract

This prospective phase II clinical trial (Side Out 2) explored the clinical benefits of treatment selection informed by multi‐omic molecular profiling (MoMP) in refractory metastatic breast cancers (MBCs). Core needle biopsies were collected from 32 patients with MBC at trial enrollment. Patients had received an average of 3.94 previous lines of treatment in the metastatic setting before enrollment in this study. Samples underwent MoMP, including exome sequencing, RNA sequencing (RNA‐Seq), immunohistochemistry, and quantitative protein pathway activation mapping by Reverse Phase Protein Microarray (RPPA). Clinical benefit was assessed using the previously published growth modulation index (GMI) under the hypothesis that MoMP‐selected therapy would warrant further investigation for GMI ≥ 1.3 in ≥ 35% of the patients. Of the 32 patients enrolled, 29 received treatment based on their MoMP and 25 met the follow‐up criteria established by the trial protocol. Molecular information was delivered to the tumor board in a median time frame of 14 days (11–22 days), and targetable alterations for commercially available agents were found in 23/25 patients (92%). Of the 25 patients, 14 (56%) reached GMI ≥ 1.3. A high level of DNA topoisomerase I (TOPO1) led to the selection of irinotecan‐based treatments in 48% (12/25) of the patients. A pooled analysis suggested clinical benefit in patients with high TOPO1 expression receiving irinotecan‐based regimens (GMI ≥ 1.3 in 66.7% of cases). These results confirmed previous observations that MoMP increases the frequency of identifiable actionable alterations (92% of patients). The MoMP proposed allows the identification of biomarkers that are frequently expressed in MBCs and the evaluation of their role as predictors of response to commercially available agents. Lastly, this study confirmed the role of MoMP for informing treatment selection in refractory MBC patients: more than half of the enrolled patients reached a GMI ≥ 1.3 even after multiple lines of previous therapies for metastatic disease. [ABSTRACT FROM AUTHOR]

Published
2022
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41. A Noninvasive Blood-based Combinatorial Proteomic Biomarker Assay to Detect Breast Cancer in Women over age 50 with BI-RADS 3, 4, or 5 Assessment

Author

Henderson, Meredith C., primary, Silver, Michael, additional, Tran, Quynh, additional, Letsios, Elias E., additional, Mulpuri, Rao, additional, Reese, David E., additional, Lourenco, Ana P., additional, LaBaer, Joshua, additional, Anderson, Karen S., additional, Alpers, Josie, additional, Costantini, Carrie, additional, Rohatgi, Nitin, additional, Ali, Haythem, additional, Baker, Karen, additional, Northfelt, Donald W., additional, Ghosh, Karthik, additional, Grobmyer, Stephen R., additional, Polen, Winnie, additional, and Wolf, Judith K., additional

Published
2019
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43. Randomized, controlled study of the safety and efficacy of intravenous cidofovir for the treatment of relapsing cytomegalovirus retinitis in patients with AIDS

Author

Lalezari, Jacob P., Holland, Gary N., Kramer, Francoise, McKinley, George F., Kemper, Carol A., Ives, David V., Nelson, Robert, Hardy, W. David, Kuppermann, Baruch D., Northfelt, Donald W., Youle, Michael, Martin, Sara, Lewis, Richard Alan, Weinberg, David V., Simon, Gary L., Wolitz, Richard A., Ruby, April E., Stagg, Robert J., and Jaffe, Howard S.

Subjects
Cytomegalovirus infections -- Drug therapy, AIDS patients -- Diseases, Retinal diseases -- Drug therapy, Health, Vistide (Medication) -- Evaluation
Abstract

Cidofovir may effectively delay the progression of cytomegalovirus (CMV) retinitis in patients with AIDS. CMV retinitis is an infection in the eye that can damage the retina and lead to blindness. Researchers evaluated weekly maintenance doses of cidofovir in 150 AIDS patients with relapsing CMV retinitis that had resisted other drug treatments. Cidofovir effectively delayed progression of the condition, and prevented the need for daily intravenous medication required when other drugs are used.

Published
1998

44. Choosing wisely after publication of level I evidence in breast cancer radiotherapy

Author

Niska,Joshua R, Keole,Sameer R, Pockaj,Barbara A, Halyard,Michele Y, Patel,Samir H, Northfelt,Donald W, Gray,Richard J, Wasif,Nabil, Vargas,Carlos E, Wong,William W, Niska,Joshua R, Keole,Sameer R, Pockaj,Barbara A, Halyard,Michele Y, Patel,Samir H, Northfelt,Donald W, Gray,Richard J, Wasif,Nabil, Vargas,Carlos E, and Wong,William W

Abstract

Joshua R Niska,1 Sameer R Keole,1 Barbara A Pockaj,2 Michele Y Halyard,1 Samir H Patel,1 Donald W Northfelt,3 Richard J Gray,2 Nabil Wasif,2 Carlos E Vargas,1 William W Wong1 1Department of Radiation Oncology, 2Division of General Surgery, 3Division of Hematology and Medical Oncology, Mayo Clinic Hospital, Phoenix, AZ, USA Background: Recent trials in early-stage breast cancer support hypofractionated whole-breast radiotherapy (WBRT) as part of breast-conserving therapy (BCT). Evidence also suggests that radiotherapy (RT) omission may be reasonable for some patients over 70 years. Among radiation-delivery techniques, intensity-modulated RT (IMRT) is more expensive than 3-dimensional conformal RT (3DCRT). Based on this evidence, in 2013, the American Society for Radiation Oncology (ASTRO) recommended hypofractionated schedules for women aged ≥50 years with early-stage breast cancer and avoiding routine use of IMRT for WBRT. To assess response to level I evidence and adherence to ASTRO recommendations, we evaluated the pattern of RT use for early-stage breast cancer at our National Comprehensive Cancer Network institution from 2006 to 2008 and 2011 to 2013 and compared the results with national trends. Methods: Data from a prospective database were extracted to include patients treated with BCT, aged ≥50 years, with histologic findings of invasive ductal carcinoma, stage T1-T2N0M0, estrogen receptor-positive, and HER2 normal. We retrospectively reviewed the medical records and estimated costs based on 2016 Hospital Outpatient Prospective Payment System (technical fees) and Medicare Physician Fee Schedule (professional fees). Results: Among 55 cases from 2006 to 2008, treatment regimens were 11% hypofractionated, 69% traditional schedule, and 20% RT omission (29% of patients were aged >70 years). Among 83 cases from 2011 to 2013, treatment regimens were 54% hypofractionated, 19% traditional schedule, and 27% RT omission (48% of patients were aged &

Published
2018

45. Continuous low-dose interferon-alpha therapy for HIV-related immune thrombocytopenic purpura

Author

Northfelt, Donald W., Charlebois, Edwin D., Mirda, Marcela I., Child, Carroll, Kaplan, Lawrence D., and Abrams, Donald I.

Subjects
HIV infection -- Complications, Thrombocytopenic purpura -- Drug therapy, Interferon alpha -- Evaluation, Health
Abstract

Low-dose interferon alpha may be effective in treating immune thrombocytopenic purpura (ITP). ITP is a bleeding disorder characterized by a drop in blood platelets, which are the blood cells that form blood clots. It is common in HIV-infected people, and can have many causes. Thirteen HIV-infected patients with ITP were taught to give themselves a subcutaneous injection of three million units of interferon-alpha2b three times a week. They were examined once a month. Only one patient responded completely, eight responded partially and four did not respond at all. A complete response occurred when the patient's platelet level returned to normal and remained so for more than one month. All of the patients noticed a reduction in bleeding episodes. Most of the patients experienced side effects from the treatment, including fatigue, fever, muscle pain and headache.

Published
1995

46. Survival Benefit Needed to Undergo Chemotherapy: Patients’ and Physicians’ Preferences: Patient and Physician Preferences instead of Patients’ and Physicians’ Preferences

Author

Vaz-Luis, Ines, O’Neill, Anne, Sepucha, Karen, Miller, Kathy D, Baker, Emily, Dang, Chau T, Northfelt, Donald W, Winer, Eric P, Sledge, George W, Schneider, Bryan, and Partridge, Ann H

Subjects
Adult, Paclitaxel, Attitude of Health Personnel, Breast Neoplasms, Mastectomy, Segmental, Risk Assessment, Article, Physicians, Surveys and Questionnaires, Antineoplastic Combined Chemotherapy Protocols, Humans, Cyclophosphamide, Mastectomy, Aged, Randomized Controlled Trials as Topic, Patient Preference, Middle Aged, Tumor Burden, Bevacizumab, Survival Rate, Clinical Trials, Phase III as Topic, Chemotherapy, Adjuvant, Doxorubicin, Quality of Life, Female, Attitude to Health
Abstract

Published studies have suggested that most patients with early stage breast cancer are willing, for modest survival benefits, to receive 6 months of adjuvant cyclophosphamide, methotrexate, and 5-fluorouracil, an older regimen that is used infrequently today. We examined preferences regarding the survival benefit needed to justify 6 months of a contemporary chemotherapy regimen.The Eastern Cooperative Oncology Group Protocol 5103 was a phase 3 trial that randomized breast cancer patients to receive standard adjuvant doxorubicin, cyclophosphamide, and paclitaxel with either bevacizumab or placebo. Serial surveys to assess quality of life were administered to patients enrolled between January 1, 2010, and June 8, 2010. Survival benefit needed to justify 6 months of chemotherapy by patients was collected at the 18-month assessment. A parallel survey was sent to physicians who had enrolled patients in the study.Of 519 patients who had not withdrawn at a time point earlier than 18 months, 87.8% responded to this survey. A total of 175 physicians participated. We found considerable variation in patient preferences, particularly for modest survival benefits: for 2 months of benefit, 57% would consider 6 months of chemotherapy, whereas 96% of patients would consider 6 months of chemotherapy for 24 months. Race and education were associated with the choices. Physicians who responded were less likely to accept chemotherapy for modest benefit.Among patients who received contemporary adjuvant chemotherapy in a randomized controlled trial, we found substantial variation in preferences regarding benefits that justified undergoing chemotherapy. Differences between patients' and physicians' choices were also apparent. Eliciting preferences regarding risks and benefits of adjuvant chemotherapy is critical. Cancer 2017;123:2821-28. © 2017 American Cancer Society.

Published
2017

47. The usefulness of diagnostic bone marrow examination in patients with human immunodeficiency virus (HIV) infection

Author

Northfelt, Donald W., Mayer, Allen, Kaplan, Lawrence D., Abrams, Donald I., Hadley, W. Keith, Yajko, David M., and Herndier, Brian G.

Subjects
Bone marrow examination -- Usage, Opportunistic infections -- Diagnosis, HIV infection -- Complications, Health
Abstract

Opportunistic infections occur when infectious agents that are normally present in the body and kept in check by the immune system are able to cause infection because of the immune system's inability to function properly. Persons who are infected with HIV, the human immunodeficiency virus, are particularly susceptible. Because many of these infections affect the bone marrow, individuals who are known to be or suspected of being HIV-infected may undergo diagnostic bone marrow examination. While the information gathered from such examinations has been useful in the diagnosis of certain infections, little is known about the range of possible infections that can be detected in this way. A retrospective study was performed in which records were examined of 387 patients who underwent bone marrow examinations. In each of these cases, the primary reason for doing bone marrow examination was because the physician believed there might be an HIV-related opportunistic infection present. It was found that no infections were diagnosed using bone marrow examination that could not have been identified using other, less invasive procedures such as blood tests. However, it is important to note that the accuracy of diagnostic bone marrow examination was similar to blood cultures, so it is an effective technique even if it is not the first choice. In the case of lymphomas (tumors of lymph tissue), however, bone marrow examination was not a useful diagnostic tool but it was able to provide information regarding the extent of lymphoma that had been diagnosed by other techniques. (Consumer Summary produced by Reliance Medical Information, Inc.)

Published
1991

48. DNA methyltransferase expression in triple-negative breast cancer predicts sensitivity to decitabine

Author

Yu, Jia, primary, Qin, Bo, additional, Moyer, Ann M., additional, Nowsheen, Somaira, additional, Liu, Tongzheng, additional, Qin, Sisi, additional, Zhuang, Yongxian, additional, Liu, Duan, additional, Lu, Shijia W., additional, Kalari, Krishna R., additional, Visscher, Daniel W., additional, Copland, John A., additional, McLaughlin, Sarah A., additional, Moreno-Aspitia, Alvaro, additional, Northfelt, Donald W., additional, Gray, Richard J., additional, Lou, Zhenkun, additional, Suman, Vera J., additional, Weinshilboum, Richard, additional, Boughey, Judy C., additional, Goetz, Matthew P., additional, and Wang, Liewei, additional

Published
2018
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50. Serum thymidine kinase 1 activity as a pharmacodynamic marker of cyclin-dependent kinase 4/6 inhibition in patients with early-stage breast cancer receiving neoadjuvant palbociclib

Author

Bagegni, Nusayba, primary, Thomas, Shana, additional, Liu, Ning, additional, Luo, Jingqin, additional, Hoog, Jeremy, additional, Northfelt, Donald W., additional, Goetz, Matthew P., additional, Forero, Andres, additional, Bergqvist, Mattias, additional, Karen, Jakob, additional, Neumüller, Magnus, additional, Suh, Edward M., additional, Guo, Zhanfang, additional, Vij, Kiran, additional, Sanati, Souzan, additional, Ellis, Matthew, additional, and Ma, Cynthia X., additional

Published
2017
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