Meredith M. Regan, ScD

Meredith M. Regan, ScD

Researcher

Contact Information

Office Phone Number

617-632-2471

Fax

617-632-5444

Biography

Meredith M. Regan, ScD

Dr. Regan earned her doctorate in Biostatistics from Harvard School of Public Health in 1998. After completing a fellowship at the Biometrics Center at Beth Israel Deaconess Medical Center, she joined the faculty at BIDMC. In 2003 Dr. Regan joined the Dana-Farber Cancer Institute Division of Biostatistics.

Researcher

Physician

Professor of Medicine, Dana-Farber Cancer Institute and Harvard Medical School

Research

    Statistical Methods in Cancer Research

    Dr. Regan’s research focuses on clinical and translational investigations to inform patient care and treatment selection for breast and genitourinary cancers. 

    Dr. Regan is Director of the IBCSG (International Breast Cancer Study Group) Statistical and Data Management Center, based in Switzerland. She co-leads the international randomized clinical trials SOFT and TEXT evaluating the adjuvant endocrine therapy in premenopausal women with early-stage breast cancer. 

    Dr. Regan’s research also includes the development and validation of clinical trial endpoints. The Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP) Working Group conducted individual patient data meta-analyses to evaluate surrogate endpoints for overall survival in randomized clinical trials for localized prostate cancer treatment. She is developing a novel endpoint for immuno-oncology studies, treatment-free survival, with an integrated analysis approach to characterize how patients spend their survival time, on and off treatment, with and without toxicity, to facilitate shared treatment decision-making.

    Research Departments

    Publications

      • Differential benefit of metronomic chemotherapy among triple negative breast cancer subtypes treated in the IBCSG Trial 22-00. Clin Cancer Res. 2023 Sep 21. View in: Pubmed

      • Efficacy of Metronomic Oral Vinorelbine, Cyclophosphamide, and Capecitabine vs Weekly Intravenous Paclitaxel in Patients With Estrogen Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer: Final Results From the Phase 2 METEORA-II Randomized Clinical Trial. JAMA Oncol. 2023 09 01; 9(9):1267-1272. View in: Pubmed

      • Standardized Definitions for Efficacy End Points in Neoadjuvant Breast Cancer Clinical Trials: NeoSTEEP. J Clin Oncol. 2023 09 20; 41(27):4433-4442. View in: Pubmed

      • Re: Matthew S. Ernst, Vishal Navani, J. Connor Wells, et al. Outcomes for International Metastatic Renal Cell Carcinoma Database Consortium Prognostic Groups in Contemporary First-line Combination Therapies for Metastatic Renal Cell Carcinoma. Eur Urol. 2023;84:109-116. Eur Urol. 2023 10; 84(4):e96-e97. View in: Pubmed

      • Clinical outcomes of de novo metastatic HER2-positive inflammatory breast cancer. NPJ Breast Cancer. 2023 Jun 02; 9(1):50. View in: Pubmed

      • Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials. J Clin Oncol. 2023 03 01; 41(7):1376-1382. View in: Pubmed

      • Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT. J Clin Oncol. 2023 03 01; 41(7):1370-1375. View in: Pubmed

      • Incidence, characteristics, and management of central nervous system metastases in patients with inflammatory breast cancer. Cancer. 2022 Dec 01; 128(23):4085-4094. View in: Pubmed

      • HER2-low inflammatory breast cancer: Clinicopathologic features and prognostic implications. Eur J Cancer. 2022 10; 174:277-286. View in: Pubmed

      • Maximizing the value of phase III trials in immuno-oncology: A checklist from the Society for Immunotherapy of Cancer (SITC). J Immunother Cancer. 2022 09; 10(9). View in: Pubmed

      • Early on-treatment transcriptional profiling as a tool for improving pathological response prediction in HER2-positive inflammatory breast cancer. Ther Adv Med Oncol. 2022; 14:17588359221113269. View in: Pubmed

      • A phase III trial of alpelisib + trastuzumab ± fulvestrant versus trastuzumab + chemotherapy in HER2+ PIK3CA-mutated breast cancer. Future Oncol. 2022 06; 18(19):2339-2349. View in: Pubmed

      • Surrogacy Beyond Prognosis: The Importance of "Trial-Level" Surrogacy. Oncologist. 2022 04 05; 27(4):266-271. View in: Pubmed

      • Serum thymidine kinase activity in patients with hormone receptor-positive and HER2-negative metastatic breast cancer treated with palbociclib and fulvestrant. Eur J Cancer. 2022 03; 164:39-51. View in: Pubmed

      • Sensitivity of treatment-free survival to subgroup analyses in patients with advanced melanoma treated with immune checkpoint inhibitors. Melanoma Res. 2022 02 01; 32(1):35-44. View in: Pubmed

      • Effect of dose reductions on clinical outcomes, or of outcomes on dose reductions? Breast. 2022 Apr; 62:179. View in: Pubmed

      • Accelerating progress to innovation for patients: Trial design and risk stratification. Breast. 2022 Mar; 62 Suppl 1:S80-S83. View in: Pubmed

      • Treatment-free Survival after Immune Checkpoint Inhibitor Therapy versus Targeted Therapy for Advanced Renal Cell Carcinoma: 42-Month Results of the CheckMate 214 Trial. Clin Cancer Res. 2021 12 15; 27(24):6687-6695. View in: Pubmed

      • Treatment-free survival over extended follow-up of patients with advanced melanoma treated with immune checkpoint inhibitors in CheckMate 067. J Immunother Cancer. 2021 11; 9(11). View in: Pubmed

      • Prepectoral versus subpectoral implant-based breast reconstruction after skin-sparing mastectomy or nipple-sparing mastectomy (OPBC-02/ PREPEC): a pragmatic, multicentre, randomised, superiority trial. BMJ Open. 2021 09 02; 11(9):e045239. View in: Pubmed

      • Dermal Lymphatic Invasion, Survival, and Time to Recurrence or Progression in Inflammatory Breast Cancer. Am J Clin Oncol. 2021 09 01; 44(9):449-455. View in: Pubmed

      • Prospective Multicenter Comparison of Open and Robotic Radical Prostatectomy: The PROST-QA/RP2 Consortium. J Urol. 2022 01; 207(1):127-136. View in: Pubmed

      • A Grant-Based Experiment to Train Clinical Investigators: The AACR/ASCO Methods in Clinical Cancer Research Workshop. Clin Cancer Res. 2021 10 15; 27(20):5472-5481. View in: Pubmed

      • Circulating tumor cell number and endocrine therapy index in ER positive metastatic breast cancer patients. NPJ Breast Cancer. 2021 Jun 11; 7(1):77. View in: Pubmed

      • Phase I study of JAK1/2 inhibitor ruxolitinib with weekly paclitaxel for the treatment of HER2-negative metastatic breast cancer. Cancer Chemother Pharmacol. 2021 05; 87(5):673-679. View in: Pubmed

      • Neoadjuvant Chemotherapy, Endocrine Therapy, and Targeted Therapy for Breast Cancer: ASCO Guideline. J Clin Oncol. 2021 05 01; 39(13):1485-1505. View in: Pubmed

      • 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. View in: Pubmed

      • 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. View in: Pubmed

      • Genomic Aberrations and Late Recurrence in Postmenopausal Women with Hormone Receptor-positive Early Breast Cancer: Results from the SOLE Trial. Clin Cancer Res. 2021 01 15; 27(2):504-512. View in: Pubmed

      • 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. View in: Pubmed

      • Dual Blockade of c-MET and the Androgen Receptor in Metastatic Castration-resistant Prostate Cancer: A Phase I Study of Concurrent Enzalutamide and Crizotinib. Clin Cancer Res. 2020 12 01; 26(23):6122-6131. View in: Pubmed

      • DNA derived from archival tumor specimens can be used for germline pharmacogenetic analyses. Pharmacogenomics. 2020 08; 21(13):899-902. View in: Pubmed

      • Identifying oncogenic drivers associated with increased risk of late distant recurrence in postmenopausal, estrogen receptor-positive, HER2-negative early breast cancer: results from the BIG 1-98 study. Ann Oncol. 2020 10; 31(10):1359-1365. View in: Pubmed

      • Event-Free Survival, a Prostate-Specific Antigen-Based Composite End Point, Is Not a Surrogate for Overall Survival in Men With Localized Prostate Cancer Treated With Radiation. J Clin Oncol. 2020 09 10; 38(26):3032-3041. View in: Pubmed

      • Estimation of historical control rate for a single arm de-escalation study - Application to the POSITIVE trial. Breast. 2020 Oct; 53:1-7. View in: Pubmed

      • 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. View in: Pubmed

      • 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. View in: Pubmed

      • DNA methylation markers predict recurrence-free interval in triple-negative breast cancer. NPJ Breast Cancer. 2020 Jan 31; 6(1):3. View in: Pubmed

      • DNA methylation markers predict recurrence-free interval in triple-negative breast cancer. NPJ Breast Cancer. 2020; 6:3. View in: Pubmed

      • Clinical and economic outcomes of treatment sequences for intermediate- to poor-risk advanced renal cell carcinoma. Immunotherapy. 2020 01; 12(1):37-51. View in: Pubmed

      • Estrogen and Progesterone Receptor Testing in Breast Cancer: ASCO/CAP Guideline Update. J Clin Oncol. 2020 04 20; 38(12):1346-1366. View in: Pubmed

      • Estrogen and Progesterone Receptor Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Guideline Update. Arch Pathol Lab Med. 2020 05; 144(5):545-563. View in: Pubmed

      • Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019. Ann Oncol. 2019 Oct; 30(10):1541-1557. View in: Pubmed

      • Prognosis of medullary breast cancer: analysis of 13 International Breast Cancer Study Group (IBCSG) trials. Ann Oncol. 2012 Nov; 23(11):2843-2851. View in: Pubmed

      • 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. View in: Pubmed

      • Corrections to "De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017". Ann Oncol. 2019 Jul; 30(7):1181. View in: Pubmed

      • Risk stratification according to stage and pathology. Breast. 2019 Nov; 48 Suppl 1:S23-S25. View in: Pubmed

      • 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. View in: Pubmed

      • Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019. Ann Oncol. 2019 10 01; 30(10):1541-1557. View in: Pubmed

      • Treatment-Free Survival: A Novel Outcome Measure of the Effects of Immune Checkpoint Inhibition-A Pooled Analysis of Patients With Advanced Melanoma. J Clin Oncol. 2019 12 10; 37(35):3350-3358. View in: Pubmed

      • Patterns of breast reconstruction in patients diagnosed with inflammatory breast cancer: The Dana-Farber Cancer Institute's Inflammatory Breast Cancer Program experience. Breast J. 2020 03; 26(3):384-390. View in: Pubmed

      • Independent Validation of EarlyR Gene Signature in BIG 1-98: A Randomized, Double-Blind, Phase III Trial Comparing Letrozole and Tamoxifen as Adjuvant Endocrine Therapy for Postmenopausal Women With Hormone Receptor-Positive, Early Breast Cancer. JNCI Cancer Spectr. 2019 Dec; 3(4):pkz051. View in: Pubmed

      • Toronto Workshop on Late Recurrence in Estrogen Receptor-Positive Breast Cancer: Part 1: Late Recurrence: Current Understanding, Clinical Considerations. JNCI Cancer Spectr. 2019 Dec; 3(4):pkz050. View in: Pubmed

      • Toronto Workshop on Late Recurrence in Estrogen Receptor-Positive Breast Cancer: Part 2: Approaches to Predict and Identify Late Recurrence, Research Directions. JNCI Cancer Spectr. 2019 Dec; 3(4):pkz049. View in: Pubmed

      • De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol. 2019 07 01; 30(7):1181. View in: Pubmed

      • Clinical and analytical validation of Ki-67 in 9069 patients from IBCSG VIII?+?IX, BIG1-98 and GeparTrio trial: systematic modulation of interobserver variance in a comprehensive in silico ring trial. Breast Cancer Res Treat. 2019 Aug; 176(3):557-568. View in: Pubmed

      • Reply to K.-D. Yu et al. J Clin Oncol. 2019 06 10; 37(17):1516-1517. View in: Pubmed

      • 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. View in: Pubmed

      • Prevalence of germline variants in inflammatory breast cancer. Cancer. 2019 07 01; 125(13):2194-2202. View in: Pubmed

      • Adjuvant Systemic Treatment of Premenopausal Women With Hormone Receptor-Positive Early Breast Cancer: Lights and Shadows. J Clin Oncol. 2019 04 10; 37(11):862-866. View in: Pubmed

      • Prognostic and predictive value of androgen receptor expression in postmenopausal women with estrogen receptor-positive breast cancer: results from the Breast International Group Trial 1-98. Breast Cancer Res. 2019 02 22; 21(1):30. View in: Pubmed

      • Expanded Prostate Cancer Index Composite-26 (EPIC-26) Online: Validation of an Internet-Based Instrument for Assessment of Health-Related Quality of Life After Treatment for Localized Prostate Cancer. Urology. 2019 05; 127:53-60. View in: Pubmed

      • Pembrolizumab plus trastuzumab in trastuzumab-resistant, advanced, HER2-positive breast cancer (PANACEA): a single-arm, multicentre, phase 1b-2 trial. Lancet Oncol. 2019 03; 20(3):371-382. View in: Pubmed

      • A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation Using Meta-analyses. JNCI Cancer Spectr. 2019 Mar; 3(1):pkz002. View in: Pubmed

      • 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. View in: Pubmed

      • Clinical and economic outcomes associated with treatment sequences in patients with BRAF-mutant advanced melanoma. Immunotherapy. 2019 03; 11(4):283-295. View in: Pubmed

      • 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. View in: Pubmed

      • Association of Somatic Driver Alterations With Prognosis in Postmenopausal, Hormone Receptor-Positive, HER2-Negative Early Breast Cancer: A Secondary Analysis of the BIG 1-98 Randomized Clinical Trial. JAMA Oncol. 2018 10 01; 4(10):1335-1343. View in: Pubmed

      • De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol. 2018 Oct 01; 29(10):2153. View in: Pubmed

      • National Cancer Institute Breast Cancer Steering Committee Working Group Report on Meaningful and Appropriate End Points for Clinical Trials in Metastatic Breast Cancer. J Clin Oncol. 2018 Nov 10; 36(32):3259-3268. View in: Pubmed

      • Quality-adjusted survival of nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone among treatment-naive patients with advanced melanoma: a quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis. Qual Life Res. 2019 Jan; 28(1):109-119. View in: Pubmed

      • 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. View in: Pubmed

      • Sequential treatment approaches in  the management of BRAF wild-type advanced melanoma: a cost-effectiveness analysis. Immunotherapy. 2018 10; 10(14):1241-1252. View in: Pubmed

      • Prognostic Value of the Progesterone Receptor by Subtype in Patients with Estrogen Receptor-Positive, HER-2 Negative Breast Cancer. Oncologist. 2019 02; 24(2):165-171. View in: Pubmed

      • Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. N Engl J Med. 2018 Jul 12; 379(2):122-137. View in: Pubmed

      • Apatorsen plus docetaxel versus docetaxel alone in platinum-resistant metastatic urothelial carcinoma (Borealis-2). Br J Cancer. 2018 05; 118(11):1434-1441. View in: Pubmed

      • Integration of Clinical Variables for the Prediction of Late Distant Recurrence in Patients With Estrogen Receptor-Positive Breast Cancer Treated With 5 Years of Endocrine Therapy: CTS5. J Clin Oncol. 2018 07 01; 36(19):1941-1948. View in: Pubmed

      • Predicting erectile function following external beam radiation therapy or brachytherapy for prostate cancer using EPIC-CP. Pract Radiat Oncol. 2018 Nov - Dec; 8(6):445-451. View in: Pubmed

      • 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. View in: Pubmed

      • A randomized phase II study evaluating different maintenance schedules of nab-paclitaxel in the first-line treatment of metastatic breast cancer: final results of the IBCSG 42-12/BIG 2-12 SNAP trial. Ann Oncol. 2018 03 01; 29(3):661-668. View in: Pubmed

      • 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. View in: Pubmed

      • Reply to 'The St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2017: the point of view of an International Panel of Experts in Radiation Oncology' by Kirova et al. Ann Oncol. 2018 01 01; 29(1):281-282. View in: Pubmed

      • Reply to Y. Zhu et al. J Clin Oncol. 2018 02 10; 36(5):515-516. View in: Pubmed

      • 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. View in: Pubmed

      • High Expression of FGD3, a Putative Regulator of Cell Morphology and Motility, Is Prognostic of Favorable Outcome in Multiple Cancers. JCO Precis Oncol. 2017; 1. View in: Pubmed

      • 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. View in: Pubmed

      • 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. View in: Pubmed

      • Metastasis-Free Survival Is a Strong Surrogate of Overall Survival in Localized Prostate Cancer. J Clin Oncol. 2017 09 20; 35(27):3097-3104. View in: Pubmed

      • De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol. 2017 08 01; 28(8):1700-1712. View in: Pubmed

      • Association Between Combined TMPRSS2:ERG and PCA3 RNA Urinary Testing and Detection of Aggressive Prostate Cancer. JAMA Oncol. 2017 Aug 01; 3(8):1085-1093. View in: Pubmed

      • Trial designs and results supporting treatment de-escalation and escalation. Breast. 2017 Aug; 34 Suppl 1:S10-S12. View in: Pubmed

      • 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. View in: Pubmed

      • The Impact of Residual Disease After Preoperative Systemic Therapy on Clinical Outcomes in Patients with Inflammatory Breast Cancer. Ann Surg Oncol. 2017 Sep; 24(9):2563-2569. View in: Pubmed

      • HER2 status predicts for upfront AI benefit: A TRANS-AIOG meta-analysis of 12,129 patients from ATAC, BIG 1-98 and TEAM with centrally determined HER2. Eur J Cancer. 2017 07; 79:129-138. View in: Pubmed

      • External Beam Radiation Therapy or Brachytherapy With or Without Short-course Neoadjuvant Androgen Deprivation Therapy: Results of a Multicenter, Prospective Study of Quality of Life. Int J Radiat Oncol Biol Phys. 2017 06 01; 98(2):304-317. View in: Pubmed

      • 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. View in: Pubmed

      • Reply to L. Moscetti. J Clin Oncol. 2017 05 10; 35(14):1628. View in: Pubmed

      • Clinical Trial Design and Endpoints for Stage IV Melanoma in the Modern Era. Cancer J. 2017 Jan/Feb; 23(1):63-67. View in: Pubmed

      • Cytochrome P-450 2D6 (CYP2D6) Genotype and Breast Cancer Recurrence in Tamoxifen-Treated Patients: Evaluating the Importance of Loss of Heterozygosity. Am J Epidemiol. 2017 01 15; 185(2):75-85. View in: Pubmed

      • 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. View in: Pubmed

      • Reply to F. Tomao et al. J Clin Oncol. 2016 12; 34(34):4189-4190. View in: Pubmed

      • Poor Prognosis After Second Locoregional Recurrences in the CALOR Trial. Ann Surg Oncol. 2017 Feb; 24(2):398-406. View in: Pubmed

      • Relief of Urinary Symptom Burden after Primary Prostate Cancer Treatment. J Urol. 2017 02; 197(2):376-384. View in: Pubmed

      • Multinational Prospective Study of Patient-Reported Outcomes After Prostate Radiation Therapy: Detailed Assessment of Rectal Bleeding. Int J Radiat Oncol Biol Phys. 2016 11 15; 96(4):770-777. View in: Pubmed

      • 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. View in: Pubmed

      • 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. View in: Pubmed

      • Are SOFT and TEXT results practice changing and how? Breast. 2016 Jun; 27:122-5. View in: Pubmed

      • Adjuvant ovarian function suppression and cognitive function in women with breast cancer. Br J Cancer. 2016 04 26; 114(9):956-64. View in: Pubmed

      • 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. View in: Pubmed

      • 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. View in: Pubmed

      • The Genomic Grade Assay Compared With Ki67 to Determine Risk of Distant Breast Cancer Recurrence. JAMA Oncol. 2016 Feb; 2(2):217-24. View in: Pubmed

      • Twelve-Month Estrogen Levels in Premenopausal Women With Hormone Receptor-Positive Breast Cancer Receiving Adjuvant Triptorelin Plus Exemestane or Tamoxifen in the Suppression of Ovarian Function Trial (SOFT): The SOFT-EST Substudy. J Clin Oncol. 2016 05 10; 34(14):1584-93. View in: Pubmed

      • Duration of Androgen Deprivation Therapy for High-Risk Prostate Cancer: Application of Randomized Trial Data in a Tertiary Referral Cancer Center. Clin Genitourin Cancer. 2016 08; 14(4):e299-305. View in: Pubmed

      • 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. View in: Pubmed

      • 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. View in: Pubmed

      • Mental health research: developing priorities and promoting its utilization to inform policies and services. East Mediterr Health J. 2015 Sep 28; 21(7):517-21. View in: Pubmed

      • The Development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP). J Natl Cancer Inst. 2015 Dec; 107(12):djv261. View in: Pubmed

      • Predicting benefit of endocrine therapy for early breast cancer. Breast. 2015 Nov; 24 Suppl 2:S129-31. View in: Pubmed

      • Genotyping concordance in DNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor and whole blood for pharmacogenetic analyses. Mol Oncol. 2015 Nov; 9(9):1868-76. View in: Pubmed

      • 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. View in: Pubmed

      • 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. View in: Pubmed

      • Improved adjuvant endocrine therapy for premenopausal women with endocrine responsive disease. Ecancermedicalscience. 2015; 9:544. View in: Pubmed

      • Cell kinetic studies fail to identify sequentially proliferating progenitors as the major source of epithelial renewal in the adult murine prostate. PLoS One. 2015; 10(5):e0128489. View in: Pubmed

      • CYP19A1 polymorphisms and clinical outcomes in postmenopausal women with hormone receptor-positive breast cancer in the BIG 1-98 trial. Breast Cancer Res Treat. 2015 Jun; 151(2):373-84. View in: Pubmed

      • Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med. 2015 04 23; 372(17):1673. View in: Pubmed

      • Inflammatory breast cancer and development of brain metastases: risk factors and outcomes. Breast Cancer Res Treat. 2015 May; 151(1):225-32. View in: Pubmed

      • Re: Loss of heterozygosity at the CYP2D6 locus in breast cancer: implications for germline pharmacogenetic studies. J Natl Cancer Inst. 2015 May; 107(5). View in: Pubmed

      • Inflammatory Breast Cancer: Patterns of Failure and the Case for Aggressive Locoregional Management. Ann Surg Oncol. 2015 Aug; 22(8):2483-91. View in: Pubmed

      • Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med. 2015 Jan 29; 372(5):436-46. View in: Pubmed

      • The high-dose aldesleukin "select" trial: a trial to prospectively validate predictive models of response to treatment in patients with metastatic renal cell carcinoma. Clin Cancer Res. 2015 Feb 01; 21(3):561-8. View in: Pubmed

      • Exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014 10 02; 371(14):1358-9. View in: Pubmed

      • 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. View in: Pubmed

      • Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014 Jul 10; 371(2):107-18. View in: Pubmed

      • Cardiovascular risk factors in women with primary Sjögren's syndrome: United Kingdom primary Sjögren's syndrome registry results. Arthritis Care Res (Hoboken). 2014 May; 66(5):757-64. View in: Pubmed

      • Response. J Natl Cancer Inst. 2014 Apr 03; 106(5). View in: Pubmed

      • Comparative effectiveness study of patient-reported outcomes after proton therapy or intensity-modulated radiotherapy for prostate cancer. Cancer. 2014 Apr 01; 120(7):1076-82. View in: Pubmed

      • A phase II study of bevacizumab and high-dose interleukin-2 in patients with metastatic renal cell carcinoma: a Cytokine Working Group (CWG) study. J Immunother. 2013 Nov-Dec; 36(9):490-5. View in: Pubmed

      • 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. View in: Pubmed

      • TOP2A protein by quantitative immunofluorescence as a predictor of response to epirubicin in the neoadjuvant treatment of breast cancer. Future Oncol. 2013 Oct; 9(10):1477-87. View in: Pubmed

      • Measuring and predicting prostate cancer related quality of life changes using EPIC for clinical practice. J Urol. 2014 Mar; 191(3):638-45. View in: Pubmed

      • Concordance between CYP2D6 genotypes obtained from tumor-derived and germline DNA. J Natl Cancer Inst. 2013 Sep 04; 105(17):1332-4. View in: Pubmed

      • Challenges of guarantee-time bias. J Clin Oncol. 2013 Aug 10; 31(23):2963-9. View in: Pubmed

      • Dramatic and prolonged PSA response after retreatment with a PSA vaccine. Clin Genitourin Cancer. 2013 Sep; 11(3):362-4. View in: Pubmed

      • CYP2D6 genotype should not be used for deciding about tamoxifen therapy in postmenopausal breast cancer. J Clin Oncol. 2013 Jul 20; 31(21):2753-5. View in: Pubmed

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      Dana-Farber Cancer Institute

      450 Brookline Avenue CLSB 11046 Boston, MA 02215
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      42.3374, -71.1082