Breast Cancer Clinical Trials and Research

Clinical Trials Questions?

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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.

Clinical Trials

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.

Breast Cancer Clinical Trial Overview

Adrienne G. Waks, MD, associate director of Breast Oncology Clinical Research gives a patient-friendly overview of what clinical trials are and how they work.

Featured Clinical Trials

Trial 21-169: Assessing the impact of scalp cooling in patients with metastatic breast cancer
Principal investigator: Elahe Salehi, DNP, ANP-BC

Trial 20-166: Saci-IO TNBC: Randomized phase 2 study of sacituzumab govitecan with or without pembrolizumab in PD-L1-negative metastatic triple negative breast cancer (TNBC)
Principal investigator: Ana Garrido-Castro, MD

Trial 23-531: SATEEN: Single-arm phase 2 trial of sacituzumab govitecan and trastuzumab for her2+ metastatic breast cancer after trastuzumab deruxtecan
Principal investigator: Adrienne G. Waks, MD

Trial 24-005: ZAP-IT: Phase 1/2, single-arm trial of azenosertib (ZN-c3) combined with carboplatin and pembrolizumab in patients with metastatic triple-negative breast cancer
Principal investigator: Filipa Lynce, MD

Trial 24-251: TRADE-DXd: Phase 2 non-comparative trial of datopotamab deruxtecan (Dato-DXd) or trastuzumab deruxtecan (T-DXd) in patients with metastatic HER2-negative (HER2-low or HER2-0) breast cancer after progression on prior antibody drug conjugate therapy
Principal investigator: Ana Garrido-Castro, MD

Trial 20-028: ASPRIA: Single arm phase 2 trial of atezolizumab with sacituzumab govitecan to prevent recurrence in triple negative breast cancer
Principal investigator: Elizabeth Ann Mittendorf, MD, PhD

Trial 22-225: ETHAN: Phase 2 study comparing different endocrine therapies for male breast cancer
Principal investigator: Jose Pablo Leone, MD

Trial 22-490: Single arm phase 1/2 trial of abemaciclib + avutometinib (VS-6766) + fulvestrant in metastatic HR+/HER2- breast cancer
Principal investigator: Adrienne G. Waks, MD

Trial 24-631: Phase 2 trial to evaluate immune-related biomarkers for pathological response in stage I-III HER2-positive breast cancer receiving neoadjuvant chemotherapy with subsequent randomization to multi-epitope HER2 vaccine vs. placebo in patients with residual disease post-neoadjuvant chemotherapy
Principal investigator: Erica L. Mayer, MD, MPH

Trial 24-772: CDK4/6 inhibitor Dosing Knowledge (CDK): Comparing oral drug dosing strategies in older patients with metastatic breast cancer to maximize tolerance and reduce discontinuation
Principal investigator: Erica L. Mayer, MD, MPH

SEARCH ALL DANA-FARBER CLINICAL TRIALS

Breast Cancer Research Plain Language Summaries

Our breast oncology experts have developed short summaries using everyday language describing the design and results of select clinical trials and studies. These plain language summaries were created with trial participants, family members/loved ones, and members of the public in mind.

Advances in Metastatic Breast Cancer Research and Treatment

Sara Tolaney, MD, MPH, chief of Breast Oncology, gives an update on recent advances in metastatic breast cancer research and treatment as of Fall 2024, highlighting movements toward more personalized treatments.

Beyond Clinical Trial Research

In addition to clinical trial research, we have a wide range of basic (laboratory) and translational studies which help us better understand the biology of breast cancer and allow us to translate research findings into better treatments for patients. We have a robust infrastructure — including facilities to store blood and tissue samples, databases for clinical data, and dedicated research staff — that allows us to carry out large cohort registry and bio-banking studies to better understand how breast cancer develops and progresses. Our physician-scientists are also involved in research that aims to improve prevention and early detection efforts as well as quality of life for the whole patient.

Patient advocates are important members of our research teams, providing a patient perspective as we conduct research and design new studies.

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

Basic (Laboratory) Research

Basic cancer researchers try to understand the biology of cancer by studying cells, molecules, or genes in a laboratory, with the aim of developing new treatments. Using cutting-edge lab models, our basic scientists are studying how breast cancer spreads (metastasizes), why some tumors become resistant to treatment, and how defects in DNA repair can be targeted. They also explore ways to make cancer cells more vulnerable to the immune system. This type of research helps lay the groundwork for future clinical trials that test new targeted therapies, drug combinations, and immunotherapies in patients. These labs are conducting ongoing basic research in breast cancer at Dana-Farber:

Translational Research

Translational research bridges the gap between basic and clinical research by turning scientific discoveries into new diagnostic tools and treatments. At Dana-Farber, our researchers identify biomarkers, test new therapies, and find ways to overcome treatment resistance. Working closely with doctors caring for patients, they help design and inform clinical trials that bring the latest advances from the lab directly to our patients. The Breast Oncology Center Translational Hub is an innovative program that collects, processes, and stores biological samples (e.g. blood, tissue, stool) donated by people participating in research  studies and turns tissue slides into digital images so they can be more easily studied and shared.

Bioinformatics is the science of using computers to analyze the information from donated biological samples. The Breast Oncology Center Computational Biology Group specializes in this type of research, applying computational methods to better understand breast cancer biology.

Cohort Registry and Bio-Banking Studies

Cohort and registry studies involve tracking groups of patients over time to collect detailed clinical, demographic, and treatment data to understand how breast cancer develops and progresses, evaluate outcomes, and identify risk factors. Bio-banking studies involve the collection, processing, and storage of biological samples from patients for future research. These samples are then linked with clinical data, which allows researchers to study disease biology, discover biomarkers, and develop new diagnostic tools and therapies. Some of our cohort and bio-banking registries include:

  • Early stage breast cancer
  • Metastatic breast cancer
  • Triple-negative breast cancer
  • Inflammatory breast cancer
  • Young adults with breast cancer
  • Older adults with breast cancer
  • Male breast cancer

Patient Focused Research

In addition to treatment-focused studies, we conduct a wide range of research aimed at improving all aspects of patient care. This includes prevention and early detection, as well as lifestyle research examining the role of diet, exercise, and other factors in breast cancer outcomes. Our researchers are also investigating integrative medicine approaches — such as yoga and acupuncture — to help manage symptoms and enhance well-being. Our supportive care studies focus on symptom management, expanding access to care for all patients, and reducing barriers to clinical trial participation.

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, 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.

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.