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Our group in the Breast Oncology Center (BOC), which includes over 25 physicians and investigators, is dedicated to improving the care of women with breast cancer through the conduct of clinical trials. More than 25 trials - spanning the spectrum of the disease - are currently open to women with breast cancer. Some focus on local treatment and adjuvant systemic therapy, while others explore questions in the preoperative setting. Our group published the first report of a preoperative trial using trastuzumab in women with stage II/III breast cancer. This trial, in turn, led to a series of studies in women with early-stage, HER2-positive disease. We also test new treatments in women with advanced disease, with the hope that, if effective, they can be used to treat women with early-stage disease to prevent recurrence. Our group is investigating a variety of novel agents that target specific pathways within cancer cells and the surrounding tissue. We incorporate translational research endpoints in the vast majority of our trials to gain a better understanding of molecular factors that may elucidate mechanisms of action and predictors of treatment effect. As a result of our work, we have built a sizeable bank of tumor and serum specimens, which are linked to detailed clinical data for each patient who has received longitudinal care in the program. We plan to expand this effort in the metastatic setting and collect serial biopsies over time to understand the molecular differences between primary and metastatic tumors and the resistance mechanisms that develop over the course of the disease. Our group is also committed to research that will improve psychosocial functioning of women with early-stage and advanced breast cancer. One recent study seeks to better understand the experience of women newly diagnosed with ductal carcinoma in situ; another examines issues facing breast cancer survivors. A new cohort study in eastern Massachusetts will focus on young women with breast cancer. We believe that the research output of the BOC, which has increased dramatically over the past 8 years, will continue to expand and have a tangible impact on the disease over the next 5 to 10 years.

Punglia RS, Kuntz KM, Winer E, Weeks JC, Burstein HJ. Optimizing adjuvant endocrine therapy in postmenopausal women with early stage breast cancer: a decision analysis. J Clin Oncol 2005;23:5178-87.

Muss HB, Woolf S, Berry D, Cirrincione C, Weiss RB, Budman D, Wood WC, Henderson IC, Hudis C, Winer E, Cohen H, Wheeler J, Norton L. Adjuvant chemotherapy is equally effective for older women and younger women with lymph node-positive breast cancer: The Cancer and Leukemia Group B experience. JAMA 2005;293:1073-81.

Burstein HJ, Harris LN, Gelman R, Lester SC, Nunes RA, Kaelin CM, Parker LM, Ellisen LW, Kuter I, Gadd MA, Christian RL, Kennedy PR, Borges VF, Bunnell CA, Younger J, Smith BL, Winer EP. Preoperative therapy with trastuzumab and paclitaxel followed by sequential adjuvant doxorubicin/cyclophosphamide for HER2 overexpressing stage II or III breast cancer. J Clin Oncol 2003;21:46-53.

Partridge AH, Gelber S, Knudsen K, Laufer M, Rosenberg R, Przypyszny M, Rein A, Winer EP. Web-based survey of fertility issues in young women with breast cancer. J Clin Oncol 2004;22:4174-83.

Keating NL, Landrum MB, Ayanian JZ, Winer EP, Guadagnoli E. The association of ambulatory care with breast cancer stage at diagnosis among Medicare beneficiaries. J Gen Intern Med 2005;20:38-44.

Partridge AH, Wang PS, Winer EP, Avorn JL. Non-adherence with adjuvant tamoxifen therapy in women with early stage-breast cancer. J Clin Oncol 2003;21:602-4.

Partridge AH, Burstein HJ, Gelman RS, Marcom PK, Winer EP. Do patients participating in clinical trials want to know study results? J Natl Cancer Inst 2003;95:491-2.

Partridge AH, Wong JS, Knudsen K, Gelman R, Sampson E, Gadd M, Bishop K, Harris JR, Winer EP. Offering participants results of a clinical trial: sharing results of a "negative study." Lancet 2005;365:963-4.

Harris LN, Kaelin C, Bellon JR, Winer EP. Preoperative therapy for operable breast cancer. In: Harris JR, Lippman ME, Morrow M, Osborne CK, editors. Diseases of the Breast. 3rd Edition. New York: Lippincott Williams & Wilkins; 2004. p.929-43.

Partridge AH, Hackett N, Blood E, Gelman R, Joffe S, Bauer-Wu S, Knudsen K, Emmons K, Collyar D, Schilsky RL, Winer EP. Oncology physician and nurse practices and attitudes regarding offering clinical trial results to study participants. J Natl Cancer Inst 2004;96:629-32.