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462 results on '"Geyer, Charles E."'

1. Behavioral and health outcomes from the NRG Oncology/NSABP B-36 trial comparing two different adjuvant therapy regimens for early-stage node-negative breast cancer

Author

Ganz, Patricia A, Bandos, Hanna, Geyer, Charles E, Robidoux, André, Paterson, Alexander HG, Polikoff, Jonathan, Baez-Diaz, Luis, Brufsky, Adam M, Fehrenbacher, Louis, Parsons, Ann W, Ward, Patrick J, Provencher, Louise, Hamm, John T, Stella, Philip J, Carolla, Robert L, Margolese, Richard G, Shibata, Henry R, Perez, Edith A, and Wolmark, Norman

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Breast Cancer, Cancer, Clinical Research, Prevention, Clinical Trials and Supportive Activities, Pediatric, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Chemotherapy, Adjuvant, Cyclophosphamide, Doxorubicin, Epirubicin, Female, Fluorouracil, Humans, Outcome Assessment, Health Care, Quality of Life, Quality of life, Amenorrhea, Cardiac function, Early-stage breast cancer, Adjuvant chemotherapy, Clinical Sciences, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundThe NSABP B-36 compared four cycles of doxorubicin and cyclophosphamide (AC) with six cycles of 5-fluorouracil, epirubicin, and cyclophosphamide (FEC-100) in node-negative early-stage breast cancer. A sub-study within B-36, focusing on symptoms, quality of life (QOL), menstrual history (MH), and cardiac function (CF) was conducted.Patients and methodsPatients completed the QOL questionnaire at baseline, during treatment, and every 6 months through 36 months. FACT-B Trial Outcome Index (TOI), symptom severity, and SF-36 Vitality and Physical Functioning (PF) scales scores were compared between the two groups using a mixed model for repeated measures analysis. MH was collected at baseline and subsequently assessed if menstrual bleeding occurred within 12 months prior to randomization. Post-chemotherapy amenorrhea outcome was examined at 18 months and was defined as lack of menses in the preceding year. Logistic regression was used to test for association of amenorrhea and treatment. CF assessment was done at baseline and 12 months. Correlation analysis was used to address associations between changes in baseline and 12-month PF and concurrent CF changes measured by LVEF.ResultsFEC-100 patients had statistically significantly lower TOI scores during chemotherapy (P = 0.02) and at 6 months (P

Published
2022

2. 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

3. 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

4. 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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5. 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

6. 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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7. 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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8. 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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9. 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

10. Breast Cancer Index in Premenopausal Women With Early-Stage Hormone Receptor–Positive Breast Cancer

Author

O’Regan, Ruth M., Zhang, Yi, Fleming, Gini F., Francis, Prudence A., Kammler, Roswitha, Viale, Giuseppe, Dell’Orto, Patrizia, Lang, Istvan, Bellet, Meritxell, Bonnefoi, Herve R., Tondini, Carlo, Villa, Federica, Bernardo, Antonio, Ciruelos, Eva M., Neven, Patrick, Karlsson, Per, Müller, Bettina, Jochum, Wolfram, Zaman, Khalil, Martino, Silvana, Geyer, Charles E., Jerzak, Katarzyna J., Davidson, Nancy E., Coleman, Robert E., Ingle, James N., van Mackelenbergh, Marion T., Loi, Sherene, Colleoni, Marco, Schnabel, Catherine A., Treuner, Kai, and Regan, Meredith M.

Abstract

IMPORTANCE: Adjuvant ovarian function suppression (OFS) with oral endocrine therapy improves outcomes for premenopausal patients with hormone receptor–positive (HR+) breast cancer but adds adverse effects. A genomic biomarker for selecting patients most likely to benefit from OFS-based treatment is lacking. OBJECTIVE: To assess the predictive and prognostic performance of the Breast Cancer Index (BCI) for OFS benefit in premenopausal women with HR+ breast cancer. DESIGN, SETTING, AND PARTICIPANTS: This prospective-retrospective translational study used all available tumor tissue samples from female patients from the Suppression of Ovarian Function Trial (SOFT). These individuals were randomized to receive 5 years of adjuvant tamoxifen alone, tamoxifen plus OFS, or exemestane plus OFS. BCI testing was performed blinded to clinical data and outcome. The a priori hypothesis was that BCI HOXB13/IL17BR ratio (BCI[H/I])–high tumors would benefit more from OFS and high BCI portended poorer prognosis in this population. Settings spanned multiple centers internationally. Participants included premenopausal female patients with HR+ early breast cancer with specimens in the International Breast Cancer Study Group tumor repository available for RNA extraction. Data were collected from December 2003 to April 2021 and were analyzed from May 2022 to October 2022. MAIN OUTCOMES AND MEASURES: Primary end points were breast cancer–free interval (BCFI) for the predictive analysis and distant recurrence-free interval (DRFI) for the prognostic analyses. RESULTS: Tumor specimens were available for 1718 of the 3047 female patients in the SOFT intention-to-treat population. The 1687 patients (98.2%) who had specimens that yielded sufficient RNA for BCI testing represented the parent trial population. The median (IQR) follow-up time was 12 (10.5-13.4) years, and 512 patients (30.3%) were younger than 40 years. Tumors were BCI(H/I)-low for 972 patients (57.6%) and BCI(H/I)-high for 715 patients (42.4%). Patients with tumors classified as BCI(H/I)-low exhibited a 12-year absolute benefit in BCFI of 11.6% from exemestane plus OFS (hazard ratio [HR], 0.48 [95% CI, 0.33-0.71]) and an absolute benefit of 7.3% from tamoxifen plus OFS (HR, 0.69 [95% CI, 0.48-0.97]) relative to tamoxifen alone. In contrast, patients with BCI(H/I)-high tumors did not benefit from either exemestane plus OFS (absolute benefit, −0.4%; HR, 1.03 [95% CI, 0.70-1.53]; P for interaction = .006) or tamoxifen plus OFS (absolute benefit, −1.2%; HR, 1.05 [95% CI, 0.72-1.54]; P for interaction = .11) compared with tamoxifen alone. BCI continuous index was significantly prognostic in the N0 subgroup for DRFI (n = 1110; P = .004), with 12-year DRFI of 95.9%, 90.8%, and 86.3% in BCI low-risk, intermediate-risk, and high-risk N0 cancers, respectively. CONCLUSIONS AND RELEVANCE: In this prospective-retrospective translational study of patients enrolled in SOFT, BCI was confirmed as prognostic in premenopausal women with HR+ breast cancer. The benefit from OFS-containing adjuvant endocrine therapy was greater for patients with BCI(H/I)-low tumors than BCI(H/I)-high tumors. BCI(H/I)-low status may identify premenopausal patients who are likely to benefit from this more intensive endocrine therapy.

Published
2024
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11. Early assessment with magnetic resonance imaging for prediction of pathologic response to neoadjuvant chemotherapy in triple-negative breast cancer: Results from the phase III BrighTNess trial

Author

Golshan, Mehra, Wong, Stephanie M., Loibl, Sibylle, Huober, Jens Bodo, O'Shaughnessy, Joyce, Rugo, Hope S., Wolmark, Norman, Ansell, Peter, Maag, David, Sullivan, Danielle M., Metzger-Filho, Otto, Von Minckwitz, Gunter, Geyer, Charles E., Jr., Sikov, William M., and Untch, Michael

Published
2020
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12. 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 A., primary, Bandos, Hanna, additional, Španić, Tanja, additional, Friedman, Sue, additional, Müller, Volkmar, additional, Kuemmel, Sherko, additional, Delaloge, Suzette, additional, Brain, Etienne, additional, Toi, Masakazu, additional, Yamauchi, Hideko, additional, de Dueñas, Eduardo-M., additional, Armstrong, Anne, additional, Im, Seock-Ah, additional, Song, Chuan-gui, additional, Zheng, Hong, additional, Sarosiek, Tomasz, additional, Sharma, Priyanka, additional, Geng, Cuizhi, additional, Fu, Peifen, additional, Rhiem, Kerstin, additional, Frauchiger-Heuer, Heike, additional, Wimberger, Pauline, additional, t'Kint de Roodenbeke, Daphné, additional, Liao, Ning, additional, Goodwin, Annabel, additional, Chakiba-Brugère, Camille, additional, Friedlander, Michael, additional, Lee, Keun Seok, additional, Giacchetti, Sylvie, additional, Takano, Toshimi, additional, Henao-Carrasco, Fernando, additional, Virani, Shamsuddin, additional, Valdes-Albini, Frances, additional, Domchek, Susan M., additional, Bane, Charles, additional, McCarron, Edward C., additional, Mita, Monica, additional, Rossi, Giovanna, additional, Rastogi, Priya, additional, Fielding, Anitra, additional, Gelber, Richard D., additional, Scheepers, Elsemieke D., additional, Cameron, David, additional, Garber, Judy, additional, Geyer, Charles E., additional, and Tutt, Andrew N.J., additional

Published
2024
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13. 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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14. 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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15. 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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17. 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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18. Supplementary Table S2 from Biomarker Data from the Phase III KATHERINE Study of Adjuvant T-DM1 versus Trastuzumab for Residual Invasive Disease after Neoadjuvant Therapy for HER2-Positive Breast Cancer

Author

Denkert, Carsten, primary, Lambertini, Chiara, primary, Fasching, Peter A., primary, Pogue-Geile, Katherine L., primary, Mano, Max S., primary, Untch, Michael, primary, Wolmark, Norman, primary, Huang, Chiun-Sheng, primary, Loibl, Sibylle, primary, Mamounas, Eleftherios P., primary, Geyer, Charles E., primary, Lucas, Peter C., primary, Boulet, Thomas, primary, Song, Chunyan, primary, Lewis, Gail D., primary, Nowicka, Malgorzata, primary, de Haas, Sanne, primary, and Basik, Mark, primary

Published
2023
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19. Supplementary Figure S2 from Biomarker Data from the Phase III KATHERINE Study of Adjuvant T-DM1 versus Trastuzumab for Residual Invasive Disease after Neoadjuvant Therapy for HER2-Positive Breast Cancer

Author

Denkert, Carsten, primary, Lambertini, Chiara, primary, Fasching, Peter A., primary, Pogue-Geile, Katherine L., primary, Mano, Max S., primary, Untch, Michael, primary, Wolmark, Norman, primary, Huang, Chiun-Sheng, primary, Loibl, Sibylle, primary, Mamounas, Eleftherios P., primary, Geyer, Charles E., primary, Lucas, Peter C., primary, Boulet, Thomas, primary, Song, Chunyan, primary, Lewis, Gail D., primary, Nowicka, Malgorzata, primary, de Haas, Sanne, primary, and Basik, Mark, primary

Published
2023
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20. Data from Biomarker Data from the Phase III KATHERINE Study of Adjuvant T-DM1 versus Trastuzumab for Residual Invasive Disease after Neoadjuvant Therapy for HER2-Positive Breast Cancer

Author

Denkert, Carsten, primary, Lambertini, Chiara, primary, Fasching, Peter A., primary, Pogue-Geile, Katherine L., primary, Mano, Max S., primary, Untch, Michael, primary, Wolmark, Norman, primary, Huang, Chiun-Sheng, primary, Loibl, Sibylle, primary, Mamounas, Eleftherios P., primary, Geyer, Charles E., primary, Lucas, Peter C., primary, Boulet, Thomas, primary, Song, Chunyan, primary, Lewis, Gail D., primary, Nowicka, Malgorzata, primary, de Haas, Sanne, primary, and Basik, Mark, primary

Published
2023
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21. Supplementary Data from HER-2 Gene Amplification, HER-2 and Epidermal Growth Factor Receptor mRNA and Protein Expression, and Lapatinib Efficacy in Women with Metastatic Breast Cancer

Author

Press, Michael F., primary, Finn, Richard S., primary, Cameron, David, primary, Di Leo, Angelo, primary, Geyer, Charles E., primary, Villalobos, Ivonne E., primary, Santiago, Angela, primary, Guzman, Roberta, primary, Gasparyan, Armen, primary, Ma, Yanling, primary, Danenberg, Kathy, primary, Martin, Anne Marie, primary, Williams, Lisa, primary, Oliva, Cristina, primary, Stein, Steven, primary, Gagnon, Robert, primary, Arbushites, Michael, primary, and Koehler, Maria T., primary

Published
2023
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22. 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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23. Long-term outcomes of dual vs single HER2-directed neoadjuvant therapy in NSABP B-41

Author

Rastogi, Priya, primary, Tang, Gong, additional, Hassan, Saima, additional, Geyer, Charles E., additional, Azar, Catherine A., additional, Magrinat, Gustav C., additional, Suga, J. Marie, additional, Bear, Harry D., additional, Baez-Diaz, Luis, additional, Sarwar, Shakir, additional, Boileau, Jean-Francois, additional, Brufsky, Adam M., additional, Shibata, Henry R., additional, Bandos, Hanna, additional, Paik, Soonmyung, additional, Yothers, Greg, additional, Swain, Sandra M., additional, Mamounas, Eleftherios P., additional, and Wolmark, Norman, additional

Published
2023
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24. Biomarker Data from the Phase III KATHERINE Study of Adjuvant T-DM1 versus Trastuzumab for Residual Invasive Disease after Neoadjuvant Therapy for HER2-Positive Breast Cancer

Author

Denkert, Carsten, primary, Lambertini, Chiara, additional, Fasching, Peter A., additional, Pogue-Geile, Katherine L., additional, Mano, Max S., additional, Untch, Michael, additional, Wolmark, Norman, additional, Huang, Chiun-Sheng, additional, Loibl, Sibylle, additional, Mamounas, Eleftherios P., additional, Geyer, Charles E., additional, Lucas, Peter C., additional, Boulet, Thomas, additional, Song, Chunyan, additional, Lewis, Gail D., additional, Nowicka, Malgorzata, additional, de Haas, Sanne, additional, and Basik, Mark, additional

Published
2023
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25. 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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26. Adjuvant trastuzumab emtansine in HER2-positive breast cancer patients with HER2-negative residual invasive disease in KATHERINE

Author

Loibl, Sibylle, primary, Huang, Chiun-Sheng, additional, Mano, Max S., additional, Mamounas, Eleftherios P., additional, Geyer, Charles E., additional, Untch, Michael, additional, Thery, Jean-Christophe, additional, Schwaner, Ingo, additional, Limentani, Steven, additional, Loman, Niklas, additional, Lübbe, Kristina, additional, Chang, Jenny C., additional, Hatschek, Thomas, additional, Tesarowski, David, additional, Song, Chunyan, additional, Lysbet de Haas, Sanne, additional, Boulet, Thomas, additional, Lambertini, Chiara, additional, and Wolmark, Norman, additional

Published
2022
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27. 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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28. 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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29. 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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30. Association of Polymorphisms in FCGR2A and FCGR3A With Degree of Trastuzumab Benefit in the Adjuvant Treatment of ERBB2/HER2–Positive Breast Cancer: Analysis of the NSABP B-31 Trial

Author

Gavin, Patrick G., Song, Nan, Kim, S. Rim, Lipchik, Corey, Johnson, Nicole L., Bandos, Hanna, Finnigan, Melanie, Rastogi, Priya, Fehrenbacher, Louis, Mamounas, Eleftherios P., Swain, Sandra M., Wickerham, D. Lawrence, Geyer, Charles E., Jr, Jeong, Jong-Hyeon, Costantino, Joseph P., Wolmark, Norman, Paik, Soonmyung, and Pogue-Geile, Kay L.

Published
2017
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31. Oral clodronate for adjuvant treatment of operable breast cancer (National Surgical Adjuvant Breast and Bowel Project protocol B-34): a multicentre, placebo-controlled, randomised trial

Author

Paterson, Alexander HG, Anderson, Stewart J, Lembersky, Barry C, Fehrenbacher, Louis, Falkson, Carla I, King, Karen M, Weir, Lorna M, Brufsky, Adam M, Dakhil, Shaker, Lad, Thomas, Baez-Diaz, Luis, Gralow, Julie R, Robidoux, André, Perez, Edith A, Zheng, Ping, Geyer, Charles E, Jr, Swain, Sandra M, Costantino, Joseph P, Mamounas, Eleftherios P, and Wolmark, Norman

Published
2012
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32. 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, Charles E., primary, Bandos, Hanna, additional, Rastogi, Priya, additional, Jacobs, Samuel A., additional, Robidoux, André, additional, Fehrenbacher, Louis, additional, Ward, Patrick J., additional, Polikoff, Jonathan, additional, Brufsky, Adam M., additional, Provencher, Louise, additional, Paterson, Alexander H. G., additional, Hamm, John T., additional, Carolla, Robert L., additional, Baez-Diaz, Luis, additional, Julian, Thomas B., additional, Swain, Sandra M., additional, Mamounas, Eleftherios P., additional, and Wolmark, Norman, additional

Published
2022
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33. 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, Charles E., primary, Bandos, Hanna, additional, Rastogi, Priya, additional, Jacobs, Samuel A., additional, Robidoux, André, additional, Fehrenbacher, Louis, additional, Ward, Patrick J., additional, Polikoff, Jonathan, additional, Brufsky, Adam M., additional, Provencher, Louise, additional, Paterson, Alexander H. G., additional, Hamm, John T., additional, Carolla, Robert L., additional, Baez-Diaz, Luis, additional, Julian, Thomas B., additional, Swain, Sandra M., additional, Mamounas, Eleftherios P., additional, and Wolmark, Norman, additional

Published
2022
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34. Concurrent Bevacizumab with a Sequential Regimen of Doxorubicin and Cyclophosphamide Followed by Docetaxel and Capecitabine as Neoadjuvant Therapy for HER2 − Locally Advanced Breast Cancer: A Phase II Trial of the NSABP Foundation Research Group

Author

Rastogi, Priya, Buyse, Marc E., Swain, Sandra M., Jacobs, Samuel A., Robidoux, André, Liepman, Marcia K., Pajon, Eduardo R., Dy, Philip A., Posada, Juan G., Jr, Melnik, Marianne K., Piette, Fanny, Geyer, Charles E., Jr, Mamounas, Elfetherios P., and Wolmark, Norman

Published
2011
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35. Abstract PD15-05: Assessment of estrogen receptor (ESR1) mRNA expression for prediction of extended aromatase inhibitor benefit in HR-positive breast cancer using NRG Oncology/NSABP B-42

Author

Mamounas, Eleftherios, primary, Bandos, Hanna, additional, Rastogi, Priya, additional, Crager, Michael R, additional, Mies, Carolyn, additional, Lucas, Peter C, additional, Geyer, Charles E, additional, Fehrenbacher, Louis, additional, Graham, Mark L, additional, Chia, Stephen KL, additional, Brufsky, Adam M, additional, Walshe, Janice M, additional, Soori, Gamini S, additional, Dakhil, Shaker R, additional, Paik, Soonmyung, additional, Swain, Sandra M, additional, Baehner, Frederick L, additional, Shak, Steven, additional, and Wolmark, Norman, additional

Published
2022
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36. Abstract OT1-02-03: Trastuzumab deruxtecan (T-DXd; DS-8201) vs trastuzumab emtansine (T-DM1) in high-risk patients with HER2-positive, residual invasive early breast cancer after neoadjuvant therapy: A randomized, phase 3 trial (DESTINY-Breast05)

Author

Geyer, Charles E, primary, Untch, Michael, additional, Prat, Aleix, additional, Rastogi, Priya, additional, Niikura, Naoki, additional, Mathias, Elton, additional, McLean, Lee Anne, additional, Wang, Yibin, additional, and Loibl, Sibylle, additional

Published
2022
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37. Abstract P1-07-04: Potential role of the antibody-dependent cellular phagocytosis (ADCP) in tumors achieving pCR in NRG Oncology/NSABP B-52

Author

Pogue-Geile, Katherine L, primary, Wang, Ying, additional, Feng, Huichen, additional, Lipchick, Corey, additional, Gavin, Patrick, additional, Kim, Rim S, additional, Cecchini, Reena S, additional, Jacobs, Samuel A, additional, Srinivasan, Ashok, additional, Swain, Sandra M, additional, Mamounas, Eleftherios, additional, Geyer, Charles E, additional, Rastogi, Priya, additional, Lucas, Peter C, additional, Osborne, C. Kent, additional, Paik, Soonmyung, additional, Wolmark, Norman, additional, and Rimawi, Mothaffar F, additional

Published
2022
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38. Abstract GS2-05: Randomized comparison of adjuvant aromatase inhibitor exemestane (E) plus ovarian function suppression (OFS) vs tamoxifen (T) plus OFS in premenopausal women with hormone receptor-positive (HR+) early breast cancer (BC): update of the combined TEXT and SOFT trials

Author

Regan, Meredith M, primary, Walley, Barbara A, additional, Fleming, Gini F, additional, Francis, Prudence A, additional, Colleoni, Marco A, additional, Láng, István, additional, Gómez, Henry L, additional, Tondini, Carlo A, additional, Burstein, Harold J, additional, Goetz, Matthew P, additional, Ciruelos, Eva M, additional, Stearns, Vered, additional, Bonnefoi, Hervé R, additional, Martino, Silvana, additional, Geyer, Charles E, additional, Chini, Claudio, additional, Minisini, Alessandro M, additional, Spazzapan, Simon, additional, Ruhstaller, Thomas, additional, Winer, Eric P, additional, Ruepp, Barbara, additional, Loi, Sherene, additional, Coates, Alan S, additional, Goldhirsch, Aron, additional, Gelber, Richard D, additional, and Pagani, Olivia, additional

Published
2022
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39. Abstract OT2-11-09: Lidera breast cancer: A phase III adjuvant study of giredestrant (GDC-9545) vs physician’s choice of endocrine therapy (ET) in patients (pts) with estrogen receptor-positive, HER2-negative early breast cancer (ER+/HER2- EBC)

Author

Bardia, Aditya, primary, Schmid, Peter, additional, Harbeck, Nadia, additional, Rimawi, Mothaffar F, additional, Hurvitz, Sara A, additional, Loi, Sherene, additional, Saji, Shigehira, additional, Jung, Kyung Hae, additional, Werutsky, Gustavo, additional, Stroyakovskii, Daniil, additional, López-Valverde, Vanesa, additional, Tesarowski, David, additional, Ye, Chenglin, additional, Davis, Michael, additional, Crnjevic, Tanja Badovinac, additional, Perez-Moreno, Pablo Diego, additional, and Geyer, Charles E, additional

Published
2022
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41. Matched cohort study of germline BRCA mutation carriers with triple negative breast cancer in brightness

Author

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

Published
2021
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42. Risk-based decision-making in the treatment of HER2-positive early breast cancer: Recommendations based on the current state of knowledge

Author

Jackisch, Christian, primary, Cortazar, Patricia, additional, Geyer, Charles E., additional, Gianni, Luca, additional, Gligorov, Joseph, additional, Machackova, Zuzana, additional, Perez, Edith A., additional, Schneeweiss, Andreas, additional, Tolaney, Sara M., additional, Untch, Michael, additional, Wardley, Andrew, additional, and Piccart, Martine, additional

Published
2021
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43. Prospective Validation of a 21-Gene Expression Assay in Breast Cancer

Author

Sparano, Joseph A., Gray, Robert J., Makower, Della F., Pritchard, Kathleen I., Albain, Kathy S., Hayes, Daniel F., Geyer, Charles E., Jr., Dees, Elizabeth C., Perez, Edith A., Olson, John A., Jr., Zujewski, JoAnne, Lively, Tracy, Badve, Sunil S., Saphner, Thomas J., Wagner, Lynne I., Whelan, Timothy J., Ellis, Matthew J., Paik, Soonmyung, Wood, William C., Ravdin, Peter, Keane, Maccon M., Gomez Moreno, Henry L., Reddy, Pavan S., Goggins, Timothy F., Mayer, Ingrid A., Brufsky, Adam M., Toppmeyer, Deborah L., Kaklamani, Virginia G., Atkins, James N., Berenberg, Jeffrey L., and Sledge, George W.

Published
2015
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44. Adjuvant Ovarian Suppression in Premenopausal Breast Cancer

Author

Francis, Prudence A., Regan, Meredith M., Fleming, Gini F., Láng, István, Ciruelos, Eva, Bellet, Meritxell, Bonnefoi, Hervé R., Climent, Miguel A., Da Prada, Gian Antonio, Burstein, Harold J., Martino, Silvana, Davidson, Nancy E., Geyer, Charles E., Jr., Walley, Barbara A., Coleman, Robert, Kerbrat, Pierre, Buchholz, Stefan, Ingle, James N., Winer, Eric P., Rabaglio-Poretti, Manuela, Maibach, Rudolf, Ruepp, Barbara, Giobbie-Hurder, Anita, Price, Karen N., Colleoni, Marco, Viale, Giuseppe, Coates, Alan S., Goldhirsch, Aron, and Gelber, Richard D.

Published
2015
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45. 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, Charles E, primary, Bandos, Hanna, additional, Rastogi, Priya, additional, Jacobs, Samuel A, additional, Robidoux, Andre, additional, Fehrenbacher, Louis, additional, Ward, Patrick J, additional, Polikoff, Jonathan, additional, Brufsky, Adam M, additional, Provencher, Louise, additional, Paterson, Alexander H.G., additional, Hamm, John T, additional, Carolla, Robert L, additional, Baez-Diaz, Luis, additional, Julian, Thomas B, additional, Swain, Sandra, additional, Mamounas, Terry, additional, and Wolmark, Norman, additional

Published
2021
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46. Abstract 532: Association of pCR and the 8-gene signature: NRG Oncology/NSABP B-41

Author

Song, Nan, primary, Tan, Xiaoqing E., additional, Wang, Ying, additional, Kim, Rim S., additional, Bandos, Hanna, additional, Tang, Gong, additional, Mamounas, Eleftherios, additional, Geyer, Charles E., additional, Rastogi, Priya, additional, Jacobs, Samuel A., additional, Srinivasan, Ashok, additional, Lucas, Peter C., additional, Paik, Soonmyung, additional, Wolmark, Norman, additional, Swain, Sandra M., additional, and Pogue-Geile, Katherine L., additional

Published
2021
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47. OlympiA: A phase III, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients with germline BRCA1/2 mutations and high-risk HER2-negative early breast cancer.

Author

Tutt, Andrew, primary, Garber, Judy Ellen, additional, Kaufman, Bella, additional, Viale, Giuseppe, additional, Fumagalli, Debora, additional, Rastogi, Priya, additional, Gelber, Richard D., additional, de Azambuja, Evandro, additional, Fielding, Anitra, additional, Balmana Gelpi, Judith, additional, Gelmon, Karen A., additional, Baker, Nigel, additional, Arahmani, Amal, additional, Senkus-Konefka, Elzbieta, additional, Mc Fadden, Eleanor, additional, Karantza, Vassiliki, additional, Lakhani, Sunil R., additional, Yothers, Greg, additional, Campbell, Christine, additional, and Geyer, Charles E., additional

Published
2021
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48. Prognostic impact of radiation therapy in tubular carcinoma of the breast

Author

Stauber, Jessica, primary, Chevli, Neil, additional, Haque, Waqar, additional, Messer, Jay A., additional, Farach, Andrew M., additional, Schwartz, Mary R., additional, Geyer, Charles E., additional, Bonefas, Elizabeth, additional, Zuhour, Raed, additional, Wong, Andrew, additional, Hatch, Sandra, additional, Brian Butler, E., additional, and Teh, Bin S., additional

Published
2021
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49. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer

Author

Tutt, Andrew N J, 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
610 Medicine & health
Abstract

BACKGROUND Poly(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. METHODS We 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. RESULTS A 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
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50. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer

Author

Tutt, Andrew N. J., Garber, Judy E., Kaufman, Bella, Viale, Giuseppe, Fumagalli, Debora, Rastogi, Priya, Gelber, Richard D., de Azambuja, Evandro, Fielding, Anitra, Balmana, Judith, Domchek, Susan M., Gelmon, Karen A., Hollingsworth, Simon J., Korde, Larissa A., Linderholm, Barbro, Bandos, Hanna, Senkus, E., Suga, Jennifer M., Shao, Z., 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, Geyer, Charles E., Tutt, Andrew N. J., Garber, Judy E., Kaufman, Bella, Viale, Giuseppe, Fumagalli, Debora, Rastogi, Priya, Gelber, Richard D., de Azambuja, Evandro, Fielding, Anitra, Balmana, Judith, Domchek, Susan M., Gelmon, Karen A., Hollingsworth, Simon J., Korde, Larissa A., Linderholm, Barbro, Bandos, Hanna, Senkus, E., Suga, Jennifer M., Shao, Z., 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.

Abstract

BACKGROUND Poly(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. METHODS We 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. RESULTS A 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<0.001). The 3-year distant disease-free survival was 87.5% in the olaparib group and 80.4% in the placebo group (difference, 7.1 percentage points; 95% CI, 3.0 to 11.1; hazard ratio for distant disease or death, 0.57; 99.5% CI, 0.39 to 0.83; P<0.001). Olaparib was associated with fewer deaths than placebo (59 and 86, respectively) (hazard ratio, 0.68; 99% CI, 0.44 to 1.05; P=0.02); however, the between-group difference was not significant at an interim-analysis boundary of a P value of less than 0.01. Safety data were consistent with known side effects of olaparib, with no excess serious adverse events or adverse events of special interest. CONCLUSIONS Among patients with high-risk, HER2-negative early breast cancer and germline BRCA1 or BRCA2 pathogenic or likely pathogenic variants, adjuvant olaparib af

Published
2021

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