Breast Oncology Program

We believe outstanding clinical care for patients with breast cancer is directly linked to an active program of breast cancer clinical trials. Our physician-scientists take the questions that arise in their clinical practices, answer them through clinical trials, and take this new knowledge back to the clinic where it can immediately benefit patients.

Breast cancer investigators are tackling cancer on multiple fronts, including immunotherapy and targeted treatments for the three subtypes: hormone receptor positive, HER2-positive, and triple-negative. This work includes primary tumors and metastatic cancer.

We offer our breast cancer patients access to more than 40 clinical trials at a time — many of which are changing the standard of care worldwide and are not available elsewhere. Our clinical trials focus on the types and phases of your disease so therapy can be targeted to your type of breast cancer.

Featured Clinical Trials

Trial 20-371: TBCRC 056: Preoperative niraparib with dostarlimab for BRCA- or PALB2-mutated breast cancer
Principal investigator: Erica L. Mayer, MD, MPH

Trial 21-518: SERENA-6: Switching to oral SERD camizestrant + CDK4/6 inhibitor vs continuing aromatase inhibitor + CDK4/6 inhibitor in HR+/HER2- metastatic breast cancer patients who develop an ESR1 mutation
Principal investigator: Erica L. Mayer, MD, MPH

Trial 18-516: PI3 kinase inhibitor GDC-0084 and trastuzumab for HER2+ brain metastases
Principal investigator: Jose Pablo Leone, MD

Trial 21-707: Abemaciclib in combination with endocrine therapy in patients age 70+ with ER+ metastatic breast cancer who have previously received a CDK4/6 inhibitor
Principal investigator: Rachel A. Freedman, MD, MPH

Trial 21-159: A phase II trial of adjuvant trastuzumab emtansine (T-DM1) followed by subcutaneous trastuzumab versus paclitaxel in combination with subcutaneous trastuzumab for stage I HER2-positive breast cancer (ATEMPT 2.0)
Principal investigator: Sara M. Tolaney, MD, MPH

Trial 20-347: A phase II study of ADjuvant Endocrine therapy, Pertuzumab, and Trastuzumab (ADEPT) for patients with anatomic stage I hormone receptor-positive, HER2-positive breast cancer
Principal investigator: Adrienne G. Waks, MD

Trial 20-166: Saci-IO TNBC: Randomized phase II study of sacituzumab govitecan with or without pembrolizumab in PD-L1-negative metastatic triple negative breast cancer (TNBC)
Principal investigator: Ana C. Garrido-Castro, MD

Trial 20-153: SACI-IO HR+: Randomized phase II study of sacituzumab govitecan with or without pembrolizumab in hormone receptor-positive (HR+) / HER2- metastatic breast cancer (MBC)
Principal investigator: Ana C. Garrido-Castro, MD

Trial 20-068: MARGetuximab Or Trastuzumab (MARGOT): A phase II study comparing neoadjuvant paclitaxel/margetuximab/pertuzumab to paclitaxel/trastuzumab/pertuzumab in patients with Stage II-III HER2-positive breast cancer
Principal investigator: Adrienne G. Waks, MD

Trial 20-028: A phase II trial of atezolizumab with sacituzumab govitecan to prevent recurrence in triple negative breast cancer (ASPRIA)
Principal investigator: Elizabeth Ann Mittendorf, MD, PhD

Patient Advocates Review Clinical and Translational Research

At the Susan F. Smith Center for Women's Cancers, breast cancer patients are not only the beneficiaries of research advances; in a patient-centered approach, they help guide the research itself. The Breast Cancer Advocacy Group (BCAG), composed chiefly of breast cancer patients and survivors, provide a patient perspective to the Center's clinical investigators. The group reviews concepts and protocols for clinical trials from a patient’s perspective. For example, the advocates might recommend revisions to research questions so they more closely reflect the concerns of patients.

The advocates are also members of project teams for the Breast SPORE (Specialized Program of Research Excellence) from the National Cancer Institute, reviewing applications for institutional and SPORE-funded Career Development Awards, and working hand-in-hand with investigators to design research studies.

Learn more about breast cancer patient advocates, including how to become one.

For Physicians: Breast Cancer Treatment Guidelines

Our breast oncology experts actively review clinical research data and develop guidelines on how physicians can best utilize certain treatments recently approved by the Food and Drug Administration.