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1. Impact of dose reductions on adjuvant abemaciclib efficacy for patients with high-risk early breast cancer: analyses from the monarchE study.

Author

Goetz, Matthew, Cicin, Irfan, Testa, Laura, Tolaney, Sara, Huober, Jens, Guarneri, Valentina, Johnston, Stephen, Martin, Miguel, Rastogi, Priya, Harbeck, Nadia, Shahir, Ashwin, Wei, Ran, André, Valérie, Rugo, Hope, and OShaughnessy, Joyce

Abstract

In monarchE, adjuvant abemaciclib significantly improved invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), with sustained benefit beyond the 2-year treatment period. Abemaciclib dose reductions were allowed to proactively manage adverse events. Exploratory analyses to investigate the impact of dose reductions on efficacy were conducted. Across the three patient subgroups as defined by relative dose intensity (≤66%, 66-93%, ≥93%), the estimated 4-year IDFS rates were generally consistent (87.1%, 86.4%, and 83.7%, respectively). In the time-dependent Cox proportional hazard model, the effect of abemaciclib was consistent at the full dose compared to being reduced to a lower dose (IDFS hazard ratio: 0.905; 95% confidence interval: 0.727, 1.125; DRFS hazard ratio: 0.942; 95% confidence interval: 0.742, 1.195). These analyses showed that the efficacy of adjuvant abemaciclib was not compromised by protocol mandated dose reductions for patients with node positive, hormone receptor positive, human epidermal growth factor 2-negative, high-risk early breast cancer.

Published
2024

2. Patient-Reported Outcomes in OlympiA: A Phase III, Randomized, Placebo-Controlled Trial of Adjuvant Olaparib in gBRCA1/2 Mutations and High-Risk Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer.

Author

Ganz, Patricia, Bandos, Hanna, Španić, Tanja, Friedman, Sue, Müller, Volkmar, Kuemmel, Sherko, Delaloge, Suzette, Brain, Etienne, Toi, Masakazu, Yamauchi, Hideko, de Dueñas, Eduardo-M, Armstrong, Anne, Im, Seock-Ah, Song, Chuan-Gui, Zheng, Hong, Sarosiek, Tomasz, Sharma, Priyanka, Geng, Cuizhi, Fu, Peifen, Rhiem, Kerstin, Frauchiger-Heuer, Heike, Wimberger, Pauline, tKint de Roodenbeke, Daphné, Liao, Ning, Goodwin, Annabel, Chakiba-Brugère, Camille, Friedlander, Michael, Lee, Keun, Giacchetti, Sylvie, Takano, Toshimi, Henao-Carrasco, Fernando, Virani, Shamsuddin, Valdes-Albini, Frances, Domchek, Susan, Bane, Charles, McCarron, Edward, Mita, Monica, Rossi, Giovanna, Rastogi, Priya, Fielding, Anitra, Gelber, Richard, Scheepers, Elsemieke, Cameron, David, Garber, Judy, Geyer, Charles, and Tutt, Andrew

Subjects
Female, Humans, BRCA1 Protein, BRCA2 Protein, Breast Neoplasms, Fatigue, Mutation, Nausea, Patient Reported Outcome Measures, Phthalazines, Piperazines, Quality of Life, Receptor, ErbB-2, Vomiting
Abstract

PURPOSE: The OlympiA randomized phase III trial compared 1 year of olaparib (OL) or placebo (PL) as adjuvant therapy in patients with germline BRCA1/2, high-risk human epidermal growth factor receptor 2-negative early breast cancer after completing (neo)adjuvant chemotherapy ([N]ACT), surgery, and radiotherapy. The patient-reported outcome primary hypothesis was that OL-treated patients may experience greater fatigue during treatment. METHODS: Data were collected before random assignment, and at 6, 12, 18, and 24 months. The primary end point was fatigue, measured with the Functional Assessment of Chronic Illness Therapy-Fatigue scale. Secondary end points, assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 item, included nausea and vomiting (NV), diarrhea, and multiple functional domains. Scores were compared between treatment groups using mixed model for repeated measures. Two-sided P values

Published
2024

3. Adjuvant Abemaciclib Plus Endocrine Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, High-Risk Early Breast Cancer: Results From a Preplanned monarchE Overall Survival Interim Analysis, Including 5-Year Efficacy Outcomes.

Author

Rastogi, Priya, OShaughnessy, Joyce, Martin, Miguel, Boyle, Frances, Cortes, Javier, Goetz, Matthew, Hamilton, Erika, Huang, Chiun-Sheng, Senkus, Elzbieta, Tryakin, Alexey, Cicin, Irfan, Testa, Laura, Neven, Patrick, Huober, Jens, Shao, Zhimin, Wei, Ran, André, Valérie, Munoz, Maria, San Antonio, Belen, Shahir, Ashwin, Harbeck, Nadia, Johnston, Stephen, and Rugo, Hope

Subjects
Humans, Female, Breast Neoplasms, Neoplasm Recurrence, Local, Adjuvants, Immunologic, Receptor, ErbB-2, Antineoplastic Combined Chemotherapy Protocols, Aminopyridines, Benzimidazoles
Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical trial updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.Two years of adjuvant abemaciclib combined with endocrine therapy (ET) resulted in a significant improvement in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) that persisted beyond the 2-year treatment period in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer (EBC). Here, we report 5-year efficacy results from a prespecified overall survival (OS) interim analysis. In the intent-to-treat population, with a median follow-up of 54 months, the benefit of abemaciclib was sustained with hazard ratios of 0.680 (95% CI, 0.599 to 0.772) for IDFS and 0.675 (95% CI, 0.588 to 0.774) for DRFS. This persistence of abemaciclib benefit translated to continuous separation of the curves with a deepening in 5-year absolute improvement in IDFS and DRFS rates of 7.6% and 6.7%, respectively, compared with rates of 6% and 5.3% at 4 years and 4.8% and 4.1% at 3 years. With fewer deaths in the abemaciclib plus ET arm compared with the ET-alone arm (208 v 234), statistical significance was not reached for OS. No new safety signals were observed. In conclusion, abemaciclib plus ET continued to reduce the risk of developing invasive and distant disease recurrence beyond the completion of treatment. The increasing absolute improvement at 5 years is consistent with a carryover effect and further supports the use of abemaciclib in patients with high-risk EBC.

Published
2024

5. Identifying Principal Stratum Causal Effects Conditional on a Post-treatment Intermediate Response

Author

Tan, Xiaoqing, Abberbock, Judah, Rastogi, Priya, and Tang, Gong

Subjects
Statistics - Methodology, Statistics - Applications
Abstract

In neoadjuvant trials on early-stage breast cancer, patients are usually randomized into a control group and a treatment group with an additional target therapy. Early efficacy of the new regimen is assessed via the binary pathological complete response (pCR) and the eventual efficacy is assessed via long-term clinical outcomes such as survival. Although pCR is strongly associated with survival, it has not been confirmed as a surrogate endpoint. To fully understand its clinical implication, it is important to establish causal estimands such as the causal effect in survival for patients who would achieve pCR under the new regimen. Under the principal stratification framework, previous studies focus on sensitivity analyses by varying model parameters in an imposed model on counterfactual outcomes. Under mild assumptions, we propose an approach to estimate those model parameters using empirical data and subsequently the causal estimand of interest. We also extend our approach to address censored outcome data. The proposed method is applied to a recent clinical trial and its performance is evaluated via simulation studies., Comment: Accepted by the 1st Conference on Causal Learning and Reasoning (CLeaR 2022), PMLR

Published
2021

6. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer

Author

Tutt, Andrew NJ, Garber, Judy E, Kaufman, Bella, Viale, Giuseppe, Fumagalli, Debora, Rastogi, Priya, Gelber, Richard D, de Azambuja, Evandro, Fielding, Anitra, Balmaña, Judith, Domchek, Susan M, Gelmon, Karen A, Hollingsworth, Simon J, Korde, Larissa A, Linderholm, Barbro, Bandos, Hanna, Senkus, Elżbieta, Suga, Jennifer M, Shao, Zhimin, Pippas, Andrew W, Nowecki, Zbigniew, Huzarski, Tomasz, Ganz, Patricia A, Lucas, Peter C, Baker, Nigel, Loibl, Sibylle, McConnell, Robin, Piccart, Martine, Schmutzler, Rita, Steger, Guenther G, Costantino, Joseph P, Arahmani, Amal, Wolmark, Norman, McFadden, Eleanor, Karantza, Vassiliki, Lakhani, Sunil R, Yothers, Greg, Campbell, Christine, and Geyer, Charles E

Subjects
Digestive Diseases, Breast Cancer, Cancer, Clinical Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adult, Antineoplastic Agents, Breast Neoplasms, Chemotherapy, Adjuvant, Disease-Free Survival, Double-Blind Method, Female, Genes, BRCA1, Genes, BRCA2, Germ-Line Mutation, Humans, Mastectomy, Middle Aged, Phthalazines, Piperazines, Poly(ADP-ribose) Polymerase Inhibitors, Receptor, ErbB-2, OlympiA Clinical Trial Steering Committee and Investigators, Receptor, erbB-2, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundPoly(adenosine diphosphate-ribose) polymerase inhibitors target cancers with defects in homologous recombination repair by synthetic lethality. New therapies are needed to reduce recurrence in patients with BRCA1 or BRCA2 germline mutation-associated early breast cancer.MethodsWe conducted a phase 3, double-blind, randomized trial involving patients with human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors who had received local treatment and neoadjuvant or adjuvant chemotherapy. Patients were randomly assigned (in a 1:1 ratio) to 1 year of oral olaparib or placebo. The primary end point was invasive disease-free survival.ResultsA total of 1836 patients underwent randomization. At a prespecified event-driven interim analysis with a median follow-up of 2.5 years, the 3-year invasive disease-free survival was 85.9% in the olaparib group and 77.1% in the placebo group (difference, 8.8 percentage points; 95% confidence interval [CI], 4.5 to 13.0; hazard ratio for invasive disease or death, 0.58; 99.5% CI, 0.41 to 0.82; P

Published
2021

7. NRG Oncology/NSABP B-47 menstrual history study: impact of adjuvant chemotherapy with and without trastuzumab

Author

Ganz, Patricia A, Cecchini, Reena S, Fehrenbacher, Louis, Geyer, Charles E, Rastogi, Priya, Crown, John P, Thirlwell, Michael P, Ellison, David M, Boileau, Jean-Francois, Flynn, Patrick J, Jeong, Jong-Hyeon, Mamounas, Eleftherios P, and Wolmark, Norman

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Contraception/Reproduction, Breast Cancer, Clinical Trials and Supportive Activities, Estrogen, Clinical Research, Cancer, Prevention, Reproductive health and childbirth, Good Health and Well Being, Clinical sciences, Oncology and carcinogenesis, Epidemiology
Abstract

The NRG Oncology/NSABP B-47 menstrual history (MH) study examined trastuzumab effects on menstrual status and associated circulating reproductive hormones. MH was evaluated by questions related to hysterectomy, oophorectomy, and reported menstrual changes. Pre/perimenopausal women were assessed at entry, 3, 6, 12, 18, 24, 30, and 36 months. Consenting women had estradiol and FSH measurement at entry, 3, 6, 12, 18, and 24 months. Logistic regression determined predictors of amenorrhea and hormone levels at 12, 24, and 36 months. Between 2/8/2011 and 2/10/2015, 3270 women with node-positive/high-risk node-negative HER2-low breast cancer were enrolled. There were 1,458 women enrolled in the MH study; 1231 consented to baseline blood samples. Trastuzumab did not contribute to a higher amenorrhea rate. Amenorrhea predictors were consistent with earlier studies; however, to our knowledge, this is the largest prospective study to include serial reproductive hormone measurements to 24 months and clinical amenorrhea reports to 36 months. These data can help to counsel patients regarding premature menopause risk.

Published
2021

8. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial

Author

Johnston, Stephen R D, Toi, Masakazu, O'Shaughnessy, Joyce, Rastogi, Priya, Campone, Mario, Neven, Patrick, Huang, Chiun-Sheng, Huober, Jens, Jaliffe, Georgina Garnica, Cicin, Irfan, Tolaney, Sara M, Goetz, Matthew P, Rugo, Hope S, Senkus, Elzbieta, Testa, Laura, Del Mastro, Lucia, Shimizu, Chikako, Wei, Ran, Shahir, Ashwin, Munoz, Maria, San Antonio, Belen, André, Valérie, Harbeck, Nadia, and Martin, Miguel

Published
2023
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9. Phase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor–Positive, Early-Stage Breast Cancer

Author

Chavez-MacGregor, Mariana, primary, Miao, Jieling, additional, Pusztai, Lajos, additional, Goetz, Matthew P., additional, Rastogi, Priya, additional, Ganz, Patricia A., additional, Mamounas, Eleftherios P., additional, Paik, Soonmyung, additional, Bandos, Hanna, additional, Razaq, Wajeeha, additional, O'Dea, Anne, additional, Kaklamani, Virginia, additional, Silber, Andrea L.M., additional, Flaum, Lisa E., additional, Andreopoulou, Eleni, additional, Wendt, Albert G., additional, Carney, Jennifer F., additional, Sharma, Priyanka, additional, Gralow, Julie R., additional, Lew, Danika L., additional, Barlow, William E., additional, and Hortobagyi, Gabriel N., additional

Published
2024
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10. A phase III trial evaluating addition of adjuvant chemotherapy to ovarian function suppression + endocrine therapy in premenopausal women with pN0-1, HR+/HER2- breast cancer (BC) and oncotype recurrence score (RS) ≤25 (OFSET): NRG-BR009.

Author

Swain, Sandra M., primary, Tang, Gong, additional, Puhalla, Shannon L., additional, Ganz, Patricia A., additional, Henry, Norah Lynn, additional, Cecchini, Reena S., additional, Reid, Sonya A., additional, Rastogi, Priya, additional, Geyer, Charles E., additional, White, Julia R., additional, Clark, Amy Sanders, additional, Haddad, Tufia C., additional, Vidal, Gregory A., additional, Wolmark, Norman, additional, and Mamounas, Eleftherios P., additional

Published
2024
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11. Recurrence score gene axes scores and outcomes by race and ethnicity in the RxPONDER trial.

Author

Abdou, Yara, primary, Hoag, Jess R, additional, Barlow, William E., additional, Gralow, Julie R., additional, Meric-Bernstam, Funda, additional, Albain, Kathy S., additional, Hayes, Daniel F., additional, Lin, Nancy U., additional, Perez, Edith A., additional, Goldstein, Lori J., additional, Chia, Stephen K. L., additional, Dhesy-Thind, Sukhbinder K., additional, Rastogi, Priya, additional, Schott, Anne F., additional, Racz, Jennifer M., additional, Tripathy, Debashish, additional, Hortobagyi, Gabriel N., additional, Pusztai, Lajos, additional, Sharma, Priyanka, additional, and Kalinsky, Kevin, additional

Published
2024
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12. Correlation of serum anti-Müllerian hormone (AMH) levels on identification of premenopausal patients (pts) with hormone receptor positive (HR+), HER2-negative, node-positive breast cancer most likely to benefit from adjuvant chemotherapy in SWOG S1007 (RxPONDER).

Author

Kalinsky, Kevin, primary, Barlow, William E., additional, Pathak, Harsh B, additional, Gralow, Julie R., additional, Albain, Kathy S., additional, Hayes, Daniel F., additional, Lin, Nancy U., additional, Perez, Edith A., additional, Goldstein, Lori J., additional, Chia, Stephen K. L., additional, Rastogi, Priya, additional, Schott, Anne F., additional, Shak, Steven, additional, Tripathy, Debashish, additional, Hortobagyi, Gabriel N., additional, Meric-Bernstam, Funda, additional, Sharma, Priyanka, additional, Pusztai, Lajos, additional, Thompson, Alastair Mark, additional, and Godwin, Andrew K., additional

Published
2024
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13. Supplementary Figure S1 from Breast Cancer Index and Prediction of Extended Aromatase Inhibitor Therapy Benefit in Hormone Receptor-Positive Breast Cancer from the NRG Oncology/NSABP B-42 Trial

Author

Mamounas, Eleftherios P., primary, Bandos, Hanna, primary, Rastogi, Priya, primary, Zhang, Yi, primary, Treuner, Kai, primary, Lucas, Peter C., primary, Geyer, Charles E., primary, Fehrenbacher, Louis, primary, Chia, Stephen K., primary, Brufsky, Adam M., primary, Walshe, Janice M., primary, Soori, Gamini S., primary, Dakhil, Shaker, primary, Paik, Soonmyung, primary, Swain, Sandra M., primary, Sgroi, Dennis C., primary, Schnabel, Catherine A., primary, and Wolmark, Norman, primary

Published
2024
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14. Data from Breast Cancer Index and Prediction of Extended Aromatase Inhibitor Therapy Benefit in Hormone Receptor-Positive Breast Cancer from the NRG Oncology/NSABP B-42 Trial

Author

Mamounas, Eleftherios P., primary, Bandos, Hanna, primary, Rastogi, Priya, primary, Zhang, Yi, primary, Treuner, Kai, primary, Lucas, Peter C., primary, Geyer, Charles E., primary, Fehrenbacher, Louis, primary, Chia, Stephen K., primary, Brufsky, Adam M., primary, Walshe, Janice M., primary, Soori, Gamini S., primary, Dakhil, Shaker, primary, Paik, Soonmyung, primary, Swain, Sandra M., primary, Sgroi, Dennis C., primary, Schnabel, Catherine A., primary, and Wolmark, Norman, primary

Published
2024
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15. Supplementary Table from Breast Cancer Index and Prediction of Extended Aromatase Inhibitor Therapy Benefit in Hormone Receptor-Positive Breast Cancer from the NRG Oncology/NSABP B-42 Trial

Author

Mamounas, Eleftherios P., primary, Bandos, Hanna, primary, Rastogi, Priya, primary, Zhang, Yi, primary, Treuner, Kai, primary, Lucas, Peter C., primary, Geyer, Charles E., primary, Fehrenbacher, Louis, primary, Chia, Stephen K., primary, Brufsky, Adam M., primary, Walshe, Janice M., primary, Soori, Gamini S., primary, Dakhil, Shaker, primary, Paik, Soonmyung, primary, Swain, Sandra M., primary, Sgroi, Dennis C., primary, Schnabel, Catherine A., primary, and Wolmark, Norman, primary

Published
2024
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16. Definitive results of a phase III adjuvant trial comparing six cycles of FEC-100 to four cycles of AC in women with operable node-negative breast cancer: the NSABP B-36 trial (NRG Oncology)

Author

Geyer, Jr., Charles E., Bandos, Hanna, Rastogi, Priya, Jacobs, Samuel A., Robidoux, André, Fehrenbacher, Louis, Ward, Patrick J., Polikoff, Jonathan, Brufsky, Adam M., Provencher, Louise, Paterson, Alexander H. G., Hamm, John T., Carolla, Robert L., Baez-Diaz, Luis, Julian, Thomas B., Swain, Sandra M., Mamounas, Eleftherios P., and Wolmark, Norman

Published
2022
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17. Long-Term Follow-Up of Cardiac Function and Quality of Life for Patients in NSABP Protocol B-31/NRG Oncology: A Randomized Trial Comparing the Safety and Efficacy of Doxorubicin and Cyclophosphamide (AC) Followed by Paclitaxel With AC Followed by Paclitaxel and Trastuzumab in Patients With Node-Positive Breast Cancer With Tumors Overexpressing Human Epidermal Growth Factor Receptor 2

Author

Ganz, Patricia A, Romond, Edward H, Cecchini, Reena S, Rastogi, Priya, Geyer, Charles E, Swain, Sandra M, Jeong, Jong-Hyeon, Fehrenbacher, Louis, Gross, Howard M, Brufsky, Adam M, Flynn, Patrick J, Wahl, Tanya A, Seay, Thomas E, Wade, James L, Biggs, David D, Atkins, James N, Polikoff, Jonathan, Zapas, John L, Mamounas, Eleftherios P, and Wolmark, Norman

Subjects
Clinical Research, Patient Safety, Breast Cancer, Cancer, Heart Disease, Clinical Trials and Supportive Activities, Prevention, Cardiovascular, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Cancer Survivors, Cardiovascular System, Chemotherapy, Adjuvant, Cohort Studies, Cyclophosphamide, Doxorubicin, Female, Follow-Up Studies, Humans, Lymphatic Metastasis, Middle Aged, Paclitaxel, Quality of Life, Receptor, ErbB-2, Trastuzumab, Ventricular Dysfunction, Left, Receptor, erbB-2, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

Purpose Early cardiac toxicity is a risk associated with adjuvant chemotherapy plus trastuzumab. However, objective measures of cardiac function and health-related quality of life are lacking in long-term follow-up of patients who remain cancer free after completion of adjuvant treatment. Patients and Methods Patients in NSABP Protocol B-31 received anthracycline and taxane chemotherapy with or without trastuzumab for adjuvant treatment of node-positive, human epidermal growth factor receptor 2-positive early-stage breast cancer. A long-term follow-up assessment was undertaken for patients who were alive and disease free, which included measurement of left ventricular ejection fraction by multigated acquisition scan along with patient-reported outcomes using the Duke Activity Status Index (DASI), the Medical Outcomes Study questionnaire, and a review of current medications and comorbid conditions. Results At a median follow-up of 8.8 years among eligible participants, five (4.5%) of 110 in the control group and 10 (3.4%) of 297 in the trastuzumab group had a > 10% decline in left ventricular ejection fraction from baseline to a value < 50%. Lower DASI scores correlated with age and use of medications for hypertension, cardiac conditions, diabetes, and hyperlipidemia, but not with whether patients had received trastuzumab. Conclusion In patients without underlying cardiac disease at baseline, the addition of trastuzumab to adjuvant anthracycline and taxane-based chemotherapy does not result in long-term worsening of cardiac function, cardiac symptoms, or health-related quality of life. The DASI questionnaire may provide a simple and useful tool for monitoring patient-reported changes that reflect cardiac function.

Published
2017

19. The Effect on Surgical Complications of Bevacizumab Added to Neoadjuvant Chemotherapy for Breast Cancer: NRG Oncology/NSABP Protocol B-40

Author

Bear, Harry D, Tang, Gong, Rastogi, Priya, Geyer, Charles E, Zoon, Christine K, Kidwell, Kelley M, Robidoux, André, Baez-Diaz, Luis, Brufsky, Adam M, Mehta, Rita S, Fehrenbacher, Louis, Young, James A, Senecal, Francis M, Gaur, Rakesh, Margolese, Richard G, Adams, Paul T, Gross, Howard M, Costantino, Joseph P, Paik, Soonmyung, Swain, Sandra M, Mamounas, Eleftherios P, and Wolmark, Norman

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Cancer, Breast Cancer, Clinical Research, Patient Safety, Evaluation of treatments and therapeutic interventions, 6.4 Surgery, Anthracyclines, Antineoplastic Combined Chemotherapy Protocols, Bevacizumab, Breast Neoplasms, Combined Modality Therapy, Docetaxel, Female, Follow-Up Studies, Humans, Mammaplasty, Mastectomy, Prognosis, Prospective Studies, Surgical Wound Infection, Survival Rate, Taxoids, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundNRG Oncology/NSABP trial B-40 tested the impact of adding bevacizumab (bev) to neoadjuvant chemotherapy for operable breast cancer. Secondary endpoints included rates of surgical complications after surgery in patients who did or did not receive bev.MethodsA total of 1206 women with HER2-negative operable breast cancer were randomly assigned to receive one of three different docetaxel-plus-anthracycline-based regimens, without or with bev (15 mg/kg every 3 weeks) for the first 6 of 8 cycles and for 10 doses postoperatively. Surgical complications were assessed from date of surgery through 24 months following study entry.ResultsEarly surgical complications were significantly more frequent in the bev group (25.4 vs. 18.9%; trend test p = 0.008), but most were grade 1-2. Early noninfectious wound dehiscences were infrequent and not significantly different (5.4 vs. 3.1%; trend test p = 0.15). Long-term noninfectious wound complications were significantly higher for patients receiving bev (11.8 vs. 5.1%; trend test p = 0.0007), but the incidence of grade ≥3 wound dehiscence was low in both groups (

Published
2017

20. Long-Term Follow-Up of the Anthracyclines in Early Breast Cancer Trials (USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 [NRG Oncology]).

Author

Geyer Jr, Charles E., Blum, Joanne L., Yothers, Greg, Asmar, Lina, Flynn, Patrick J., Robert, Nicholas J., Hopkins, Judith O., O'Shaughnessy, Joyce A., Rastogi, Priya, Puhalla, Shannon L., Hilton, Christie J., Dang, Chau T., Gómez, Henry Leonidas, Vukelja, Svetislava J., Lyss, Alan P., Paul, Devchand, Brufsky, Adam M., Colangelo, Linda H., Swain, Sandra M., and Mamounas, Eleftherios P.

Published
2024
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21. Effect of metformin versus placebo on metabolic factors in the MA.32 randomized breast cancer trial

Author

Goodwin, Pamela J., Dowling, Ryan J. O., Ennis, Marguerite, Chen, Bingshu E., Parulekar, Wendy R., Shepherd, Lois E., Burnell, Margot J., Vander Meer, Rachel, Molckovsky, Andrea, Gurjal, Anagha, Gelmon, Karen A., Ligibel, Jennifer A., Hershman, Dawn L., Mayer, Ingrid A., Whelan, Timothy J., Hobday, Timothy J., Rastogi, Priya, Rabaglio-Poretti, Manuela, Lemieux, Julie, Thompson, Alastair M., Rea, Daniel W., and Stambolic, Vuk

Published
2021
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22. Matched cohort study of germline BRCA mutation carriers with triple negative breast cancer in brightness

Author

Metzger-Filho, Otto, Collier, Katharine, Asad, Sarah, Ansell, Peter J., Watson, Mark, Bae, Junu, Cherian, Mathew, O’Shaughnessy, Joyce, Untch, Michael, Rugo, Hope S., Huober, Jens B., Golshan, Mehra, Sikov, William M., von Minckwitz, Gunter, Rastogi, Priya, Li, Lang, Cheng, Lijun, Maag, David, Wolmark, Norman, Denkert, Carsten, Symmans, W. Fraser, Geyer, Jr., Charles E., Loibl, Sibylle, and Stover, Daniel G.

Published
2021
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25. Correction to: Definitive results of a phase III adjuvant trial comparing six cycles of FEC-100 to four cycles of AC in women with operable node-negative breast cancer: the NSABP B-36 trial (NRG Oncology)

Author

Geyer, Jr., Charles E., Bandos, Hanna, Rastogi, Priya, Jacobs, Samuel A., Robidoux, André, Fehrenbacher, Louis, Ward, Patrick J., Polikoff, Jonathan, Brufsky, Adam M., Provencher, Louise, Paterson, Alexander H. G., Hamm, John T., Carolla, Robert L., Baez-Diaz, Luis, Julian, Thomas B., Swain, Sandra M., Mamounas, Eleftherios P., and Wolmark, Norman

Published
2022
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26. Correction to: Pterocarpus marsupium extract extends replicative lifespan in budding yeast

Author

Lee, Mitchell B., Kiflezghi, Michael G., Tsuchiya, Mitsuhiro, Wasko, Brian, Carr, Daniel T., Uppal, Priya A., Grayden, Katherine A., Elala, Yordanos C., Nguyen, Tu Anh, Wang, Jesse, Rastogi, Priya, Nguyen, Sunny, Zhao, Yan Ting, Kim, Deborah, Thon, Socheata, Sinha, Irika, Tang, Thao T., Tran, Ngoc H. B., Tran, Thu H. B., Moore, Margarete D., Li, Mary Ann K., Rodriguez, Karl, Promislow, Daniel E. L., and Kaeberlein, Matt

Published
2022
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27. Effect of Metformin Versus Placebo on New Primary Cancers in Canadian Cancer Trials Group MA.32: A Secondary Analysis of a Phase III Randomized Double-Blind Trial in Early Breast Cancer

Author

Goodwin, Pamela J., primary, Chen, Bingshu E., additional, Gelmon, Karen A., additional, Whelan, Timothy J., additional, Ennis, Marguerite, additional, Lemieux, Julie, additional, Ligibel, Jennifer A., additional, Hershman, Dawn L., additional, Mayer, Ingrid A., additional, Hobday, Timothy J., additional, Bliss, Judith M., additional, Rastogi, Priya, additional, Rabaglio-Poretti, Manuela, additional, Thompson, Alastair M., additional, Rea, Daniel W., additional, Stos, Paul M., additional, Shepherd, Lois E., additional, Stambolic, Vuk, additional, and Parulekar, Wendy R., additional

Published
2023
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28. Replication of genetic associations of chemotherapy-related cardiotoxicity in the adjuvant NSABP B-31 clinical trial

Author

Advani, Pooja P., primary, Ruddy, Kathryn J., additional, Herrmann, Joerg, additional, Ray, Jordan C., additional, Craver, Emily C., additional, Yothers, Greg, additional, Cecchini, Reena S., additional, Lipchik, Corey, additional, Feng, Huichen, additional, Rastogi, Priya, additional, Mamounas, Eleftherios P., additional, Swain, Sandra M., additional, Geyer, Charles E., additional, Wolmark, Norman, additional, Paik, Soonmyung, additional, Pogue-Geile, Katherine L., additional, Colon-Otero, Gerardo, additional, Perez, Edith A., additional, and Norton, Nadine, additional

Published
2023
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29. Ten-year update: NRG Oncology/National Surgical Adjuvant Breast and Bowel Project B-42 randomized trial: extended letrozole therapy in early-stage breast cancer

Author

Mamounas, Eleftherios P, primary, Bandos, Hanna, additional, Rastogi, Priya, additional, Lembersky, Barry C, additional, Jeong, Jong-Hyeon, additional, Geyer, Charles E, additional, Fehrenbacher, Louis, additional, Chia, Stephen K, additional, Brufsky, Adam M, additional, Walshe, Janice M, additional, Soori, Gamini S, additional, Dakhil, Shaker R, additional, Wade, James L, additional, McCarron, Edward C, additional, Swain, Sandra M, additional, and Wolmark, Norman, additional

Published
2023
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31. Pathologic Complete Response and Individual Patient Prognosis After Neoadjuvant Chemotherapy Plus Anti–Human Epidermal Growth Factor Receptor 2 Therapy of Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer

Author

van Mackelenbergh, Marion T., primary, Loibl, Sibylle, additional, Untch, Michael, additional, Buyse, Marc, additional, Geyer, Charles E., additional, Gianni, Luca, additional, Schneeweiss, Andreas, additional, Conte, Pierfranco, additional, Piccart, Martine, additional, Bonnefoi, Herve, additional, Jackisch, Christian, additional, Nekljudova, Valentina, additional, Tang, Gong, additional, Valagussa, Pinuccia, additional, Neate, Colin, additional, Gelber, Richard, additional, Poncet, Coralie, additional, Squifflet, Pierre, additional, Saad, Everardo D., additional, Heinzmann, Dominik, additional, Denkert, Carsten, additional, Rastogi, Priya, additional, Cortes, Javier, additional, Guarneri, Valentina, additional, de Azambuja, Evandro, additional, Cameron, David, additional, Ismael, Gustavo, additional, Wolmark, Norman, additional, and Cortazar, Patricia, additional

Published
2023
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32. Epirubicin With Cyclophosphamide Followed by Docetaxel With Trastuzumab and Bevacizumab as Neoadjuvant Therapy for HER2-Positive Locally Advanced Breast Cancer or as Adjuvant Therapy for HER2-Positive Pathologic Stage III Breast Cancer: A Phase II Trial of the NSABP Foundation Research Group, FB-5

Author

Smith, John W., II, Buyse, Marc E., Rastogi, Priya, Geyer, Charles E., Jr., Jacobs, Samuel A., Patocskai, Erica J., Robidoux, André, Conlin, Alison K., Ansari, Bilal, Keogh, George P., Stella, Philip J., Gross, Howard M., Lord, Raymond S., Polikoff, Jonathan A., Mauquoi, Celine, Mamounas, Eleftherios P., Swain, Sandra M., and Wolmark, Norman

Published
2017
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33. Supplementary Data from NSABP B-41, a Randomized Neoadjuvant Trial: Genes and Signatures Associated with Pathologic Complete Response

Author

Swain, Sandra M., primary, Tang, Gong, primary, Brauer, Heather Ann, primary, Goerlitz, David S., primary, Lucas, Peter C., primary, Robidoux, André, primary, Harris, Brent T., primary, Bandos, Hanna, primary, Ren, Yuqi, primary, Geyer, Charles E., primary, Rastogi, Priya, primary, Mamounas, Eleftherios P., primary, and Wolmark, Norman, primary

Published
2023
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34. Abstract GS1-07: Results from a phase III randomized, placebo-controlled clinical trial evaluating adjuvant endocrine therapy +/- 1 year of everolimus in patients with high-risk hormone receptor-positive, HER2-negative breast cancer: SWOG S1207

Author

Chavez, Marianna, primary, Miao, Jieling, additional, Pusztai, Lajos, additional, Goetz, Matthew P., additional, Rastogi, Priya, additional, Ganz, Patricia A., additional, Mamounas, Eleftherios (Terry), additional, Paik, Soonmyung, additional, Bandos, Hanna, additional, Razaq, Wajeeha, additional, O’Dea, Anne, additional, Kaklamani, Virginia, additional, Silber, Andrea L.M., additional, Flaum, Lisa E., additional, Andreopolu, Eleni, additional, Baar, Joseph, additional, Wendt, Albert G., additional, Carney, Jennifer F., additional, Sharma, Priyanka, additional, Gralow, Julie R., additional, Lew, Danika L., additional, Barlow, William E., additional, and Hortobagyi, Gabriel N., additional

Published
2023
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35. Abstract GS1-04: Patient-reported cognitive impairment in women participating in the RxPONDER trial (SWOG S1007) by menopausal status

Author

Kang, Irene, primary, Forschmiedt, Jamie K., additional, Loch, Michelle M., additional, Barlow, William E., additional, Lew, Danika L., additional, Gralow, Julie R., additional, Meric-Bernstam, Funda, additional, Albain, Kathy S., additional, Hayes, Daniel F., additional, Lin, Nancy U., additional, Perez, Edith A., additional, Goldstein, Lori J., additional, Rastogi, Priya, additional, Schott, Anne F., additional, Shak, Steven, additional, Sharma, Priyanka, additional, Miao, Jieling, additional, Tripathy, Debu, additional, Pusztai, Lajos, additional, Hortobagyi, Gabriel N., additional, Kalinsky, Kevin, additional, and Henry, N. Lynn, additional

Published
2023
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36. Abstract GS1-09: Abemaciclib plus endocrine therapy for HR+, HER2-, node-positive, high-risk early breast cancer: results from a pre-planned monarchE overall survival interim analysis, including 4-year efficacy outcomes

Author

Johnston, Stephen, primary, Toi, Masakazu, additional, O’Shaughnessy, Joyce, additional, Rastogi, Priya, additional, Campone, Mario, additional, Neven, Patrick, additional, Huang, Chiun Sheng, additional, Huober, Jens, additional, Jaliffe, Georgina Garnica, additional, Cicin, Irfan, additional, Tolaney, Sara, additional, Goetz, Matthew P., additional, Rugo, Hope, additional, Senkus, Elżbieta, additional, Testa, Laura, additional, Mastro, Lucia Del, additional, Shimizu, Chikako, additional, Wei, Ran, additional, Shahir, Ashwin, additional, Munoz, Maria, additional, Antonio, Belen San, additional, Andre, Valerie, additional, Harbeck, Nadia, additional, and Martín, Miguel, additional

Published
2023
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37. Abstract GS1-01: Race and clinical outcomes in the RxPONDER Trial (SWOG S1007)

Author

Abdou, Yara, primary, Barlow, William E., additional, Gralow, Julie R., additional, Meric-Bernstam, Funda, additional, Albain, Kathy S., additional, Hayes, Daniel F., additional, Lin, Nancy U., additional, Perez, Edith A., additional, Goldstein, Lori J., additional, Chia, Stephen K., additional, Dhesy-Thind, Sukhbinder, additional, Rastogi, Priya, additional, Alba, Emilio, additional, Delaloge, Suzette, additional, Schott, Anne F., additional, Shak, Steven, additional, Sharma, Priyanka, additional, Lew, Danika L., additional, Miao, Jieling, additional, Unger, Joseph M., additional, Tripathy, Debu, additional, Pusztai, Lajos, additional, Hortobagyi, Gabriel N., additional, and Kalinsky, Kevin, additional

Published
2023
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38. Abstract P6-05-06: Patient-reported anxiety and fatigue in women enrolled in the RxPONDER trial (SWOG S1007) by menopausal status

Author

Loch, Michelle M., primary, Forschmiedt, Jamie K., additional, Kang, Irene M., additional, Gralow, Julie R., additional, Meric-Bernstam, Funda, additional, Albain, Kathy S., additional, Hayes, Daniel F., additional, Lin, Nancy U., additional, Perez, Edith A., additional, Goldstein, Lori J., additional, Rastogi, Priya, additional, Schott, Anne F., additional, Shak, Steven, additional, Sharma, Priyanka, additional, Lew, Danika L., additional, Miao, Jieling, additional, Barlow, William E., additional, Tripathy, Debu, additional, Pusztai, Lajos, additional, Hortobagyi, Gabriel N., additional, Kalinsky, Kevin, additional, and Henry, N. Lynn, additional

Published
2023
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39. Abstract OT2-16-05: Safety Analyses of NRG BR004: A Randomized, Double-blind, Phase III Trial of Taxane/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-line HER2-Positive Metastatic Breast Cancer (MBC)

Author

Geyer, Jr, Charles E., primary, Tang, Gong, additional, Rastogi, Priya, additional, Valero, Vicente, additional, Chia, Stephen K., additional, Cobain, Erin F., additional, Obeid, Elias, additional, Page, David B., additional, Poklepovic, Andrew S., additional, Irvin, Jr., William J., additional, Brufsky, Adam M., additional, Wapnir, Irene L., additional, Suga, Jennifer M., additional, Mamounas, Eleftherios (Terry), additional, and Wolmark, Norman, additional

Published
2023
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40. Abstract P1-04-10: Association of stromal tumor infiltrating lymphocytes (sTILs) in pretreatment biopsies in different molecular subtypes of HER2+/ER+ breast cancer: Assessment of NRG Oncology/NSABP B-52

Author

Pogue-Geile, Katherine L., primary, Maley, Sai K., additional, Kim, Rim S., additional, Wang, Ying, additional, Salgado, Roberto, additional, Lipchik, Corey, additional, Feng, Huichen, additional, Cecchini, Reena S., additional, Jacobs, Samuel A., additional, Srinivasan, Ashok, additional, Mamounas, Eleftherios (Terry), additional, Jr, Charles E. Geyer, additional, Rastogi, Priya, additional, Osborne, C. Kent, additional, Paik, Soonmyung, additional, Wolmark, Norman, additional, Lucas, Peter C., additional, and Rimawi, Mothaffar, additional

Published
2023
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43. Neoadjuvant plus adjuvant bevacizumab in early breast cancer (NSABP B-40 [NRG Oncology]): secondary outcomes of a phase 3, randomised controlled trial

Author

Bear, Harry D, Tang, Gong, Rastogi, Priya, Geyer, Charles E, Jr, Liu, Qing, Robidoux, André, Baez-Diaz, Luis, Brufsky, Adam M, Mehta, Rita S, Fehrenbacher, Louis, Young, James A, Senecal, Francis M, Gaur, Rakesh, Margolese, Richard G, Adams, Paul T, Gross, Howard M, Costantino, Joseph P, Paik, Soonmyung, Swain, Sandra M, Mamounas, Eleftherios P, and Wolmark, Norman

Published
2015
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44. Effects of metformin versus placebo on vitamin B12 metabolism in non-diabetic breast cancer patients in CCTG MA.32

Author

Lohmann, Ana Elisa, Liebman, Mira F., Brien, William, Parulekar, Wendy R., Gelmon, Karen A., Shepherd, Lois E., Ligibel, Jennifer A., Hershman, Dawn L., Rastogi, Priya, Mayer, Ingrid A., Hobday, Timothy J., Lemieux, Julie, Thompson, Alastair Mark, Pritchard, Kathleen I., Whelan, Timothy Joseph, Mukherjee, Som D., Chalchal, Haji I., Bernstein, Vanessa, Stambolic, Vuk, Chen, Bingshu E., Goodwin, Pamela Jean, and From the CCTG, Alliance, SWOG, ECOG, NSABP Cooperative Groups

Published
2017
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45. Poor Prognosis After Second Locoregional Recurrences in the CALOR Trial

Author

Wapnir, Irene L., Gelber, Shari, Anderson, Stewart J., Mamounas, Eleftherios P., Robidoux, André, Martín, Miguel, Nortier, Johan W. R., Geyer, Jr, Charles E., Paterson, Alexander H. G., Láng, István, Price, Karen N., Coates, Alan S., Gelber, Richard D., Rastogi, Priya, Regan, Meredith M., Wolmark, Norman, Aebi, Stefan, and On behalf of CALOR trial investigators

Published
2017
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46. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis

Author

Cortazar, Patricia, Zhang, Lijun, Untch, Michael, Mehta, Keyur, Costantino, Joseph P, Wolmark, Norman, Bonnefoi, Hervé, Cameron, David, Gianni, Luca, Valagussa, Pinuccia, Swain, Sandra M, Prowell, Tatiana, Loibl, Sibylle, Wickerham, D Lawrence, Bogaerts, Jan, Baselga, Jose, Perou, Charles, Blumenthal, Gideon, Blohmer, Jens, Mamounas, Eleftherios P, Bergh, Jonas, Semiglazov, Vladimir, Justice, Robert, Eidtmann, Holger, Paik, Soonmyung, Piccart, Martine, Sridhara, Rajeshwari, Fasching, Peter A, Slaets, Leen, Tang, Shenghui, Gerber, Bernd, Geyer, Charles E, Jr, Pazdur, Richard, Ditsch, Nina, Rastogi, Priya, Eiermann, Wolfgang, and von Minckwitz, Gunter

Published
2014
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47. Chemotherapy for isolated locoregional recurrence of breast cancer (CALOR): a randomised trial

Author

Aebi, Stefan, Gelber, Shari, Anderson, Stewart J, Láng, István, Robidoux, André, Martín, Miguel, Nortier, Johan W R, Paterson, Alexander H G, Rimawi, Mothaffar F, Cañada, José Manuel Baena, Thürlimann, Beat, Murray, Elizabeth, Mamounas, Eleftherios P, Geyer, Charles E, Jr, Price, Karen N, Coates, Alan S, Gelber, Richard D, Rastogi, Priya, Wolmark, Norman, and Wapnir, Irene L

Published
2014
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48. Re-Evaluation of Pathologic Complete Response as a Surrogate for Event-Free and Overall Survival in Human Epidermal Growth Factor Receptor 2–Positive, Early Breast Cancer Treated With Neoadjuvant Therapy Including Anti–Human Epidermal...

Author

Squifflet, Pierre, Saad, Everardo D., Loibl, Sibylle, van Mackelenbergh, Marion T., Untch, Michael, Rastogi, Priya, Gianni, Luca, Schneeweiss, Andreas, Conte, Pierfranco, Piccart, Martine, Bonnefoi, Hervé, Jackisch, Christian, Nekljudova, Valentina, Tang, Gong, Valagussa, Pinuccia, Neate, Colin, Gelber, Richard, Poncet, Coralie, Heinzmann, Dominik, and Denkert, Carsten

Published
2023
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49. Lapatinib as a component of neoadjuvant therapy for HER2-positive operable breast cancer (NSABP protocol B-41): an open-label, randomised phase 3 trial

Author

Robidoux, André, Tang, Gong, Rastogi, Priya, Geyer, Charles E, Jr, Azar, Catherine A, Atkins, James N, Fehrenbacher, Louis, Bear, Harry D, Baez-Diaz, Louis, Sarwar, Shakir, Margolese, Richard G, Farrar, William B, Brufsky, Adam M, Shibata, Henry R, Bandos, Hanna, Paik, Soonmyung, Costantino, Joseph P, Swain, Sandra M, Mamounas, Eleftherios P, and Wolmark, Norman

Published
2013
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50. Effect of Metformin vs Placebo on Invasive Disease–Free Survival in Patients With Breast Cancer

Author

Goodwin, Pamela J., primary, Chen, Bingshu E., additional, Gelmon, Karen A., additional, Whelan, Timothy J., additional, Ennis, Marguerite, additional, Lemieux, Julie, additional, Ligibel, Jennifer A., additional, Hershman, Dawn L., additional, Mayer, Ingrid A., additional, Hobday, Timothy J., additional, Bliss, Judith M., additional, Rastogi, Priya, additional, Rabaglio-Poretti, Manuela, additional, Mukherjee, Som D., additional, Mackey, John R., additional, Abramson, Vandana G., additional, Oja, Conrad, additional, Wesolowski, Robert, additional, Thompson, Alastair M., additional, Rea, Daniel W., additional, Stos, Paul M., additional, Shepherd, Lois E., additional, Stambolic, Vuk, additional, and Parulekar, Wendy R., additional

Published
2022
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