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Richard D. Gelber, PhD


Researcher

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Richard D. Gelber, PhD

Researcher

  • Professor of Pediatrics (Biostatistics), Harvard Medical School
  • Professor of Biostatistics, Harvard T.H. Chan School of Public Health

Contact Information

  • Office Phone Number617-632-3603
  • Fax617-632-2444

Bio

Dr. Gelber received his PhD in operations research (major field: applied probability and statistics) from Cornell University in 1975. He has been at DFCI since 1977 and served as coordinating statistician for the DFCI Pediatric Acute Lymphoblastic Leukemia Consortium from 1977 to 2006 and statistical director of the Pediatric AIDS Clinical Trials Group from 1988 to 1998. He has been the Statistical Director for the International Breast Cancer Study Group since 1978.  In 1993, he was elected a fellow of the American Statistical Association. In addition, he was awarded an Honorary Doctorate in Medicine, University of Göteborg, Sweden in 1997.

Recent Awards:

  • Susan G. Komen Foundation Brinker Award for Scientific Distinction in Clinical Research 2008
  • St. Gallen Conference Breast Cancer Award 2009
  • ECCO (European CanCer Organisation) Clinical Research Award 2011
  • European Institute of Oncology Award for Breast Cancer Research 2002
  • Jacqueline Seroussi Memorial Foundation for Cancer Research Award 2005

Research

Q-TWiST, Quality-Adjusted Survival, Subpopulation Treatment Effect Pattern Plot (STEPP) and Breast Cancer Clinical Trials

Dr. Gelber developed the Q-TWiST method (Quality-adjusted Time Without Symptoms of disease and Toxicity of treatment) for incorporating quality-of-life considerations into treatment comparisons. This quality-adjusted survival technique provides a framework to balance the benefits of disease control against the costs of treatment side effects using threshold utility analysis and patient preferences. He also created the STEPP method (Subpopulation Treatment Effect Pattern Plot) which uses data from randomized clinical trials to graphically illustrate the pattern of differences in treatment effectiveness as a function of a covariate of interest. Dr. Gelber has directed the Statistical Center for the International Breast Cancer Study Group (IBCSG) since 1978. This consortium of institutions conducts Phase III clinical trials for adjuvant therapy for breast cancer. In addition, he is the senior biostatistician for two three major studies of adjuvant treatment for HER2-positive breast cancer conducted by the Breast International Group (BIG: the HERA and, ALTTO and APHINITY trials).

Tailoring the optimal duration of the extended adjuvant endocrine therapy in patients with early-stage breast cancer. A systematic review and meta-analysis of randomized clinical trials. Breast. 2023 Mar 02; 69:258-264.
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Ten-year survival of neoadjuvant dual HER2 blockade in patients with HER2-positive breast cancer. Eur J Cancer. 2023 03; 181:92-101.
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Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials. J Clin Oncol. 2023 Mar 01; 41(7):1376-1382.
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Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT. J Clin Oncol. 2023 Mar 01; 41(7):1370-1375.
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Surrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer: Critical Analysis of Strengths, Weaknesses, and Misinterpretations. JAMA Oncol. 2022 11 01; 8(11):1668-1675.
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Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer. Ann Oncol. 2022 12; 33(12):1250-1268.
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Association of Anticancer Immune Checkpoint Inhibitors With Patient-Reported Outcomes Assessed in Randomized Clinical Trials: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 08 01; 5(8):e2226252.
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Sex and cancer immunotherapy: Current understanding and challenges. Cancer Cell. 2022 07 11; 40(7):695-700.
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Six-year absolute invasive disease-free survival benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of the APHINITY (BIG 4-11) trial. Eur J Cancer. 2022 05; 166:219-228.
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Cardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trial. NPJ Breast Cancer. 2022 Feb 16; 8(1):18.
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Correction to: Tolerability and toxicity of trastuzumab or trastuzumab?+?lapatinib in older patients: a sub-analysis of the ALTTO trial (BIG 2-06; NCCTG (Alliance) N063D). Breast Cancer Res Treat. 2022 Jan; 191(1):225.
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Evaluation of pathological complete response as surrogate endpoint in neoadjuvant randomised clinical trials of early stage breast cancer: systematic review and meta-analysis. BMJ. 2021 12 21; 375:e066381.
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Continuous versus intermittent extended adjuvant letrozole for breast cancer: final results of randomized phase III SOLE (Study of Letrozole Extension) and SOLE Estrogen Substudy. Ann Oncol. 2021 10; 32(10):1256-1266.
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Who are the women who enrolled in the POSITIVE trial: A global study to support young hormone receptor positive breast cancer survivors desiring pregnancy. Breast. 2021 Oct; 59:327-338.
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Biological and clinical features of triple negative Invasive Lobular Carcinomas of the breast. Clinical outcome and actionable molecular alterations. Breast. 2021 Oct; 59:94-101.
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Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med. 2021 06 24; 384(25):2394-2405.
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Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial. J Clin Oncol. 2021 07 20; 39(21):2375-2385.
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Sex-Based Dimorphism of Anticancer Immune Response and Molecular Mechanisms of Immune Evasion. Clin Cancer Res. 2021 08 01; 27(15):4311-4324.
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Patient-reported function, health-related quality of life, and symptoms in APHINITY: pertuzumab plus trastuzumab and chemotherapy in HER2-positive early breast cancer. Br J Cancer. 2021 07; 125(1):38-47.
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Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D). Eur J Cancer. 2021 05; 148:287-296.
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Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. J Clin Oncol. 2021 05 01; 39(13):1448-1457.
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Clinical behavior of recurrent hormone receptor-positive breast cancer by adjuvant endocrine therapy within the Breast International Group 1-98 clinical trial. Cancer. 2021 03 01; 127(5):700-708.
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Cumulative incidence of cardiovascular events under tamoxifen and letrozole alone and in sequence: a report from the BIG 1-98 trial. Breast Cancer Res Treat. 2021 Feb; 185(3):697-707.
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Road Map to Safe and Well-Designed De-escalation Trials of Systemic Adjuvant Therapy for Solid Tumors. J Clin Oncol. 2020 12 01; 38(34):4120-4129.
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Tolerability and toxicity of trastuzumab or trastuzumab?+?lapatinib in older patients: a sub-analysis of the ALTTO trial (BIG 2-06; NCCTG (Alliance) N063D). Breast Cancer Res Treat. 2021 Jan; 185(1):107-116.
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Are We RESPECTing Older Patients With Breast Cancer? J Clin Oncol. 2020 11 10; 38(32):3727-3730.
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Estimation of historical control rate for a single arm de-escalation study - Application to the POSITIVE trial. Breast. 2020 Oct; 53:1-7.
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Treatment-induced symptoms, depression and age as predictors of sexual problems in premenopausal women with early breast cancer receiving adjuvant endocrine therapy. Breast Cancer Res Treat. 2020 Jun; 181(2):347-359.
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The legacy of Professor Aron Goldhirsch. Ann Oncol. 2020 06; 31(6):671-673.
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Correction: Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. Br J Cancer. 2020 Mar; 122(7):1119.
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Endocrine-responsive lobular carcinoma of the breast: features associated with risk of late distant recurrence. Breast Cancer Res. 2019 12 30; 21(1):153.
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Are we assuming too much with our statistical assumptions? Lessons learned from the ALTTO trial. Ann Oncol. 2019 Sep; 30(9):1507-1513.
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Reply to Does the expert panel at the St Gallen meeting provide an unbiased opinion about the management of women with early breast cancer? Ann Oncol. 2009 Oct; 20(10):1751-1752.
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Patterns and risk factors for locoregional failures after mastectomy for breast cancer: an International Breast Cancer Study Group report. Ann Oncol. 2012 Nov; 23(11):2852-2858.
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Prognostic and predictive role of ESR1 status for postmenopausal patients with endocrine-responsive early breast cancer in the Danish cohort of the BIG 1-98 trial. Ann Oncol. 2012 May; 23(5):1138-1144.
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Prognosis of medullary breast cancer: analysis of 13 International Breast Cancer Study Group (IBCSG) trials. Ann Oncol. 2012 Nov; 23(11):2843-2851.
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Sex-based differences of the tumor mutational burden and T-cell inflammation of the tumor microenvironment. Ann Oncol. 2019 Apr; 30(4):653-655.
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International consensus on treatment of early breast cancer: radiotherapy issues A response to 'International expert consensus on radiotherapy of early breast cancer'. Ann Oncol. 2007 Dec; 18(12):2044-2045.
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Absolute Improvements in Freedom From Distant Recurrence to Tailor Adjuvant Endocrine Therapies for Premenopausal Women: Results From TEXT and SOFT. J Clin Oncol. 2020 04 20; 38(12):1293-1303.
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A pooled analysis of the cardiac events in the trastuzumab adjuvant trials. Breast Cancer Res Treat. 2020 Jan; 179(1):161-171.
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Incidence and Management of Diarrhea With Adjuvant Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. Clin Breast Cancer. 2020 04; 20(2):174-181.e3.
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Are we assuming too much with our statistical assumptions? Lessons learned from the ALTTO trial. Ann Oncol. 2019 09 01; 30(9):1507-1513.
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Survival outcomes of the NeoALTTO study (BIG 1-06): updated results of a randomised multicenter phase III neoadjuvant clinical trial in patients with HER2-positive primary breast cancer. Eur J Cancer. 2019 09; 118:169-177.
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Sex-Based Heterogeneity in Response to Lung Cancer Immunotherapy: A Systematic Review and Meta-Analysis. J Natl Cancer Inst. 2019 08 01; 111(8):772-781.
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Dissecting the effect of hormone receptor status in patients with HER2-positive early breast cancer: exploratory analysis from the ALTTO (BIG 2-06) randomized clinical trial. Breast Cancer Res Treat. 2019 Aug; 177(1):103-114.
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Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. Br J Cancer. 2019 05; 120(10):959-967.
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Sex-based differences of the tumor mutational burden and T-cell inflammation of the tumor microenvironment. Ann Oncol. 2019 04 01; 30(4):653-655.
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Autoimmunity and Benefit from Trastuzumab Treatment in Breast Cancer: Results from the HERA Trial. Anticancer Res. 2019 Feb; 39(2):797-802.
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Final Analysis of the Prevention of Early Menopause Study (POEMS)/SWOG Intergroup S0230. J Natl Cancer Inst. 2019 02 01; 111(2):210-213.
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PERSEPHONE: are we ready to de-escalate adjuvant trastuzumab for HER2-positive breast cancer? NPJ Breast Cancer. 2019; 5:1.
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Adjuvant Anti-HER2 Therapy, Treatment-Related Amenorrhea, and Survival in Premenopausal HER2-Positive Early Breast Cancer Patients. J Natl Cancer Inst. 2019 01 01; 111(1):86-94.
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Neoadjuvant Degarelix Versus Triptorelin in Premenopausal Patients Who Receive Letrozole for Locally Advanced Endocrine-Responsive Breast Cancer: A Randomized Phase II Trial. J Clin Oncol. 2019 02 10; 37(5):386-395.
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Adjuvant Letrozole and Tamoxifen Alone or Sequentially for Postmenopausal Women With Hormone Receptor-Positive Breast Cancer: Long-Term Follow-Up of the BIG 1-98 Trial. J Clin Oncol. 2019 01 10; 37(2):105-114.
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Pregnancies during and after trastuzumab and/or lapatinib in patients with human epidermal growth factor receptor 2-positive early breast cancer: Analysis from the NeoALTTO (BIG 1-06) and ALTTO (BIG 2-06) trials. Cancer. 2019 01 15; 125(2):307-316.
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Reply to Jeffrey Graham, Omar Abdel-Rahman, Toni K. Choueiri, and Daniel Y.C. Heng's Letter to the Editor re: Fabio Conforti, Laura Pala, Vincenzo Bagnardi, et al. Cancer Immunotherapy Efficacy and Patients' Sex: A Systematic Review and Meta-analysis. Lancet Oncol 2018;19:737-46: Outcomes of Metastatic Renal Cell Carcinoma by Gender: Contrasting Results from the International mRCC Database Consortium. Eur Urol. 2019 02; 75(2):e34-e35.
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Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial. Lancet Oncol. 2018 10; 19(10):1385-1393.
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Sex as a predictor of response to cancer immunotherapy - Authors' reply. Lancet Oncol. 2018 08; 19(8):e380-e381.
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Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. N Engl J Med. 2018 Jul 12; 379(2):122-137.
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Cancer immunotherapy efficacy and patients' sex: a systematic review and meta-analysis. Lancet Oncol. 2018 06; 19(6):737-746.
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Mutational analysis of triple-negative breast cancers within the International Breast Cancer Study Group (IBCSG) Trial 22-00. Breast Cancer Res Treat. 2018 Jul; 170(2):351-360.
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Association of p27 and Cyclin D1 Expression and Benefit from Adjuvant Trastuzumab Treatment in HER2-Positive Early Breast Cancer: A TransHERA Study. Clin Cancer Res. 2018 07 01; 24(13):3079-3086.
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Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial. J Clin Oncol. 2018 04 10; 36(11):1073-1079.
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Postmastectomy Radiation Therapy in Women with T1-T2 Tumors and 1 to 3 Positive Lymph Nodes: Analysis of the Breast International Group 02-98 Trial. Int J Radiat Oncol Biol Phys. 2018 06 01; 101(2):316-324.
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Meta-STEPP with random effects. Res Synth Methods. 2018 Jun; 9(2):312-317.
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Concerns about cardiotoxicity in the HERA trial - Authors' reply. Lancet. 2017 12 23; 390(10114):2767-2768.
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Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018 01; 19(1):127-138.
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Assessing health-related quality of life in patients with breast cancer: a reply to Maratia et al. Qual Life Res. 2018 01; 27(1):149-152.
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Concurrent and sequential initiation of ovarian function suppression with chemotherapy in premenopausal women with endocrine-responsive early breast cancer: an exploratory analysis of TEXT and SOFT. Ann Oncol. 2017 Sep 01; 28(9):2225-2232.
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Oncology Physicians' Perspectives on Practices and Barriers to Fertility Preservation and the Feasibility of a Prospective Study of Pregnancy After Breast Cancer. J Adolesc Young Adult Oncol. 2017 Sep; 6(3):429-434.
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Treatment Efficacy, Adherence, and Quality of Life Among Women Younger Than 35 Years in the International Breast Cancer Study Group TEXT and SOFT Adjuvant Endocrine Therapy Trials. J Clin Oncol. 2017 Sep 20; 35(27):3113-3122.
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Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017 Jul 13; 377(2):122-131.
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Designing Clinical Trials That Accept New Arms: An Example in Metastatic Breast Cancer. J Clin Oncol. 2017 Sep 20; 35(27):3160-3168.
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11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. Lancet. 2017 03 25; 389(10075):1195-1205.
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Cholesterol, Cholesterol-Lowering Medication Use, and Breast Cancer Outcome in the BIG 1-98 Study. J Clin Oncol. 2017 Apr 10; 35(11):1179-1188.
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Reply to L. Moscetti. J Clin Oncol. 2017 05 10; 35(14):1628.
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Impact of CYP19A1 and ESR1 variants on early-onset side effects during combined endocrine therapy in the TEXT trial. Breast Cancer Res. 2016 11 08; 18(1):110.
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Timing of Radiation Therapy and Chemotherapy After Breast-Conserving Surgery for Node-Positive Breast Cancer: Long-Term Results From International Breast Cancer Study Group Trials VI and VII. Int J Radiat Oncol Biol Phys. 2016 10 01; 96(2):273-279.
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Poor Prognosis After Second Locoregional Recurrences in the CALOR Trial. Ann Surg Oncol. 2017 Feb; 24(2):398-406.
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Tumor-infiltrating lymphocytes (TILs) are a powerful prognostic marker in patients with triple-negative breast cancer enrolled in the IBCSG phase III randomized clinical trial 22-00. Breast Cancer Res Treat. 2016 07; 158(2):323-31.
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Low-Dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor-Negative Early Breast Cancer: International Breast Cancer Study Group Trial 22-00. J Clin Oncol. 2016 10 01; 34(28):3400-8.
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Treatment Adherence and Its Impact on Disease-Free Survival in the Breast International Group 1-98 Trial of Tamoxifen and Letrozole, Alone and in Sequence. J Clin Oncol. 2016 07 20; 34(21):2452-9.
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Subpopulation Treatment Effect Pattern Plot (STEPP) analysis for continuous, binary, and count outcomes. Clin Trials. 2016 08; 13(4):382-90.
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Adjuvant ovarian function suppression and cognitive function in women with breast cancer. Br J Cancer. 2016 04 26; 114(9):956-64.
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Meta-STEPP: subpopulation treatment effect pattern plot for individual patient data meta-analysis. Stat Med. 2016 09 20; 35(21):3704-16.
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Absolute Benefit of Adjuvant Endocrine Therapies for Premenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: TEXT and SOFT Trials. J Clin Oncol. 2016 07 01; 34(19):2221-31.
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Adjuvant Tamoxifen Plus Ovarian Function Suppression Versus Tamoxifen Alone in Premenopausal Women With Early Breast Cancer: Patient-Reported Outcomes in the Suppression of Ovarian Function Trial. J Clin Oncol. 2016 05 10; 34(14):1601-10.
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Annual Hazard Rates of Recurrence for Breast Cancer During 24 Years of Follow-Up: Results From the International Breast Cancer Study Group Trials I to V. J Clin Oncol. 2016 Mar 20; 34(9):927-35.
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Trastuzumab re-treatment following adjuvant trastuzumab and the importance of distant disease-free interval: the HERA trial experience. Breast Cancer Res Treat. 2016 Jan; 155(1):127-32.
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Reply to A. Oguz et al. J Clin Oncol. 2016 Feb 20; 34(6):640-1.
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Adjuvant Lapatinib and Trastuzumab for Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Results From the Randomized Phase III Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Trial. J Clin Oncol. 2016 Apr 01; 34(10):1034-42.
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ESR1 and ESR2 polymorphisms in the BIG 1-98 trial comparing adjuvant letrozole versus tamoxifen or their sequence for early breast cancer. Breast Cancer Res Treat. 2015 Dec; 154(3):543-55.
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Identifying treatment effect heterogeneity in clinical trials using subpopulations of events: STEPP. Clin Trials. 2016 Apr; 13(2):169-79.
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Predictive value and clinical utility of centrally assessed ER, PgR, and Ki-67 to select adjuvant endocrine therapy for premenopausal women with hormone receptor-positive, HER2-negative early breast cancer: TEXT and SOFT trials. Breast Cancer Res Treat. 2015 Nov; 154(2):275-86.
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Outcomes of special histotypes of breast cancer after adjuvant endocrine therapy with letrozole or tamoxifen in the monotherapy cohort of the BIG 1-98 trial. Ann Oncol. 2015 Dec; 26(12):2442-9.
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Relative Effectiveness of Letrozole Compared With Tamoxifen for Patients With Lobular Carcinoma in the BIG 1-98 Trial. J Clin Oncol. 2015 Sep 01; 33(25):2772-9.
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Efficacy of Adjuvant Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer and Tumors = 2 cm: A Meta-Analysis of the Randomized Trastuzumab Trials. J Clin Oncol. 2015 Aug 20; 33(24):2600-8.
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Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression (TEXT and SOFT): a combined analysis of two phase 3 randomised trials. Lancet Oncol. 2015 Jul; 16(7):848-58.
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Tailoring therapies--improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015. Ann Oncol. 2015 Aug; 26(8):1533-46.
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Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy. N Engl J Med. 2015 03 05; 372(10):923-32.
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Pregnancy after breast cancer: Are young patients willing to participate in clinical studies? Breast. 2015 Jun; 24(3):201-7.
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Marvin Zelen, 1927-2014. Clin Trials. 2015 Apr; 12(2):183-4.
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Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med. 2015 Jan 29; 372(5):436-46.
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Chemotherapy benefit for 'ER-positive' breast cancer and contamination of nonluminal subtypes—waiting for TAILORx and RxPONDER. Ann Oncol. 2015 Jan; 26(1):70-74.
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The AURORA initiative for metastatic breast cancer. Br J Cancer. 2014 Nov 11; 111(10):1881-7.
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Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): survival outcomes of a randomised, open-label, multicentre, phase 3 trial and their association with pathological complete response. Lancet Oncol. 2014 Sep; 15(10):1137-46.
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First results from the phase III ALTTO trial (BIG 2-06; NCCTG [Alliance] N063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone (T), their sequence (T?L), or their combination (T+L) in the adjuvant treatment of HER2-positive early breast cancer (EBC). J Clin Oncol. 2014 Jun 20; 32(18_suppl):LBA4.
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Phase III trial (Prevention of Early Menopause Study [POEMS]-SWOG S0230) of LHRH analog during chemotherapy (CT) to reduce ovarian failure in early-stage, hormone receptor-negative breast cancer: An international Intergroup trial of SWOG, IBCSG, ECOG, and CALGB (Alliance). J Clin Oncol. 2014 Jun 20; 32(18_suppl):LBA505.
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Randomized comparison of adjuvant aromatase inhibitor (AI) exemestane (E) plus ovarian function suppression (OFS) vs tamoxifen (T) plus OFS in premenopausal women with hormone receptor-positive (HR+) early breast cancer (BC): Joint analysis of IBCSG TEXT and SOFT trials. J Clin Oncol. 2014 Jun 20; 32(18_suppl):LBA1.
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Trastuzumab-associated cardiac events at 8 years of median follow-up in the Herceptin Adjuvant trial (BIG 1-01). J Clin Oncol. 2014 Jul 10; 32(20):2159-65.
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Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014 Jul 10; 371(2):107-18.
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Time to initiation of adjuvant chemotherapy for early breast cancer and outcome: the earlier, the better? J Clin Oncol. 2014 Mar 10; 32(8):717-9.
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Bone mineral density and circulating biomarkers in the BIG 1-98 trial comparing adjuvant letrozole, tamoxifen and their sequences. Breast Cancer Res Treat. 2014 Apr; 144(2):321-9.
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Chemotherapy for isolated locoregional recurrence of breast cancer (CALOR): a randomised trial. Lancet Oncol. 2014 Feb; 15(2):156-63.
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Central pathology laboratory review of HER2 and ER in early breast cancer: an ALTTO trial [BIG 2-06/NCCTG N063D (Alliance)] ring study. Breast Cancer Res Treat. 2014 Feb; 143(3):485-92.
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Reply to D. Serraino et al. J Clin Oncol. 2014 Jan 10; 32(2):161.
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Symptoms of endocrine treatment and outcome in the BIG 1-98 study. Breast Cancer Res Treat. 2014 Jan; 143(1):159-69.
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Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer: design of the TEXT and SOFT trials. Breast. 2013 Dec; 22(6):1094-100.
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Personalizing the treatment of women with early breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013. Ann Oncol. 2013 Sep; 24(9):2206-23.
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Patterns of Recurrence and outcome according to breast cancer subtypes in lymph node-negative disease: results from international breast cancer study group trials VIII and IX. J Clin Oncol. 2013 Sep 01; 31(25):3083-90.
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2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. Lancet. 2013 Sep 21; 382(9897):1021-8.
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Challenges of guarantee-time bias. J Clin Oncol. 2013 Aug 10; 31(23):2963-9.
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Effect of age on breast cancer outcomes in women with human epidermal growth factor receptor 2-positive breast cancer: results from a herceptin adjuvant trial. J Clin Oncol. 2013 Jul 20; 31(21):2692-8.
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Magnitude of trastuzumab benefit in patients with HER2-positive, invasive lobular breast carcinoma: results from the HERA trial. J Clin Oncol. 2013 Jun 01; 31(16):1954-60.
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Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol. 2013 Apr; 14(4):297-305.
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Adjuvant pegylated liposomal doxorubicin for older women with endocrine nonresponsive breast cancer who are NOT suitable for a "standard chemotherapy regimen": the CASA randomized trial. Breast. 2013 Apr; 22(2):130-137.
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CNS relapses in patients with HER2-positive early breast cancer who have and have not received adjuvant trastuzumab: a retrospective substudy of the HERA trial (BIG 1-01). Lancet Oncol. 2013 Mar; 14(3):244-8.
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Overall survival benefit for sequential doxorubicin-docetaxel compared with concurrent doxorubicin and docetaxel in node-positive breast cancer--8-year results of the Breast International Group 02-98 phase III trial. Ann Oncol. 2013 May; 24(5):1203-11.
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Prognostic interaction between expression of p53 and estrogen receptor in patients with node-negative breast cancer: results from IBCSG Trials VIII and IX. Breast Cancer Res. 2012 Nov 05; 14(6):R143.
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Obesity and risk of recurrence or death after adjuvant endocrine therapy with letrozole or tamoxifen in the breast international group 1-98 trial. J Clin Oncol. 2012 Nov 10; 30(32):3967-75.
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Breast cancer: Anastrozole and fulvestrant--combination to unlock efficacy. Nat Rev Clin Oncol. 2012 Oct; 9(10):556-7.
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Patterns and risk factors for locoregional failures after mastectomy for breast cancer: an International Breast Cancer Study Group report. Ann Oncol. 2012 Nov; 23(11):2852-2858.
View in: PubMed

A risk score based on histopathological features predicts higher risk of distant recurrence in premenopausal patients with lymph node-negative endocrine-responsive breast cancer. Breast. 2012 Oct; 21(5):621-8.
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Prognosis of medullary breast cancer: analysis of 13 International Breast Cancer Study Group (IBCSG) trials. Ann Oncol. 2012 Nov; 23(11):2843-2851.
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Subjective cognitive complaints one year after ceasing adjuvant endocrine treatment for early-stage breast cancer. Br J Cancer. 2012 May 08; 106(10):1618-25.
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CYP2D6 genotype and tamoxifen response in postmenopausal women with endocrine-responsive breast cancer: the breast international group 1-98 trial. J Natl Cancer Inst. 2012 Mar 21; 104(6):441-51.
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Health-related quality of life among children with acute lymphoblastic leukemia. Pediatr Blood Cancer. 2012 Oct; 59(4):717-24.
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Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2012 Feb 18; 379(9816):633-40.
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Assessment of letrozole and tamoxifen alone and in sequence for postmenopausal women with steroid hormone receptor-positive breast cancer: the BIG 1-98 randomised clinical trial at 8·1 years median follow-up. Lancet Oncol. 2011 Nov; 12(12):1101-8.
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Chemotherapy of advanced esophageal carcinoma: Eastern Cooperative Oncology Group experience. Cancer. 1980 Nov 15; 46(10):2149-53.
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A controlled evaluation of combined radiation and bleomycin therapy for squamous cell carcinoma of the esophagus. Int J Radiat Oncol Biol Phys. 1980 Jul; 6(7):821-6.
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Randomized preoperative and postoperative radiation therapy for patients with carcinoma of the head and neck: preliminary report. Laryngoscope. 1980 Jun; 90(6 Pt 1):930-45.
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Cell surface antigens: prognostic implications in childhood acute lymphoblastic leukemia. Blood. 1980 Mar; 55(3):395-402.
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Value of radiation therapy in the management of patients with cerebral metastases from malignant melanoma: Radiation Therapy Oncology Group Brain Metastases Study I and II. Cancer. 1980 Feb 15; 45(4):679-83.
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Basilic vein to brachial artery, arteriovenous fistula for long-term hemodialysis: a five year follow-up. Proc Clin Dial Transplant Forum. 1980; 10:126-9.
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The palliation of brain metastases: final results of the first two studies by the Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys. 1980 Jan; 6(1):1-9.
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Designing and analyzing clinical trials which allow institutions to randomize patients to a subset of the treatments under study. Biometrics. 1979 Dec; 35(4):825-9.
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Evaluation of randomized preoperative and postoperative radiation therapy for supraglottic carcinoma. Preliminary report. Ann Otol Rhinol Laryngol. 1978 Sep-Oct; 87(5 Pt 1):686-91.
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Veillonella parvula septicemia and osteomyelitis. Ann Intern Med. 1977 Jan; 86(1):63-4.
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The use of basilic vein and brachial artery as an A-V fistula for long term hemodialysis. J Surg Res. 1976 Apr; 20(4):373-6.
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Letter: Acid-fast smears in tuberculosis detection. Ann Intern Med. 1976 Mar; 84(3):344.
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