Metastatic Breast Cancer Clinical Trials and Research

Nancy Lin, MD (left) and Erica Mayer, MD, MPH

  • Because we recognize that metastatic breast cancer is not just a single disease, we personalize clinical trials to each patient's type of cancer and diagnosis, matching patients with the trial that is the most compelling and relevant for their kind of breast cancer. We are conducting multiple clinical trials to study the effect of new targeted drugs, particularly in patients with metastatic disease. Much of the research work performed at Dana-Farber has resulted in treatment breakthroughs and new standards of care for patients with metastatic disease.

See our full list of clinical trials for metastatic breast cancer.

Should you participate in a clinical trial?

Participating in a clinical trial is a very personal decision, and a choice that is completely yours to make. If it feels right to you, there are several good reasons to participate:

  • Clinical trials are how we make progress against cancer.
  • Over the past decade, thanks to participating patients, a number of new drugs have been approved for treatment of metastatic breast cancer.
  • Taking part in a clinical trial can offer you new treatment options.
  • By participating in a clinical trial, you contribute to knowledge that can help future patients.

Learn more about clinical trials and whether participating in a clinical trial is right for you.

Clinical trials for metastatic breast cancer

  • Study of DS-8201a in HER2-Low, Unresectable and/or Metastatic Breast Cancer
    Watch the video
  • Study of Carboplatin plus Nivolumab in Metastatic Triple-Negative Breast Cancer
    Watch the video
  • Study of Ribociclib and PDR001 in HR+ Metastatic Breast Cancer
    Watch the video
  • Study of Targeted Therapy for HER2-Positive Metastatic Breast Cancer
    Watch the video
  • Study of GDC-0084 with Trastuzumab in HER2-Positive Breast Cancer with Brain Metastases
    Watch the video
  • Study of Abemaciclib (Verzenio™) for Patients with RB-Positive, Triple Negative Metastatic Breast Cancer
    Watch the video
  • Study of Immunotherapy Combinations for Patients with HER2-Positive Metastatic Breast Cancer
    Watch the video
  • Study of Palbociclib (Ibrance®) after CDK & Endocrine Therapy in ER+/HER- Metastatic Breast Cancer
    Watch the video

Presentation on several new therapies for HER2-positive metastatic breast cancer including kinase inhibitors, antibody drug conjugates, and immunotherapies, as well as patient-friendly resources for exploring clinical trials.
View the presentation or view on SlideShare.

Presentation on several new clinical trials for triple negative metastatic breast cancer including antibody drug conjugates, and immunotherapy combinations, as well as patient-friendly resources for exploring clinical trials.
View the presentation or view on SlideShare.


Ending Metastatic Breast Cancer for Everyone (EMBRACE) is a research study conducted at Dana-Farber Cancer Institute. This study began recruiting patients in 2009, with the aim of learning more about the biology of advanced breast cancer, as well as the treatment experiences of patients living with it.

Each patient's progress is tracked by a study coordinator, and the information collected is used to help doctors understand more about the long-term journey of the metastatic breast cancer patients in this group. Investigators hope the study will bring them closer to finding a cure for this disease.

The study also sponsors a metastatic breast cancer forum every year, as well as webcasts of topics relevant to patients with metastatic disease.

For more information on EMBRACE, please email

Research Advances in Metastatic Breast Cancer

Research is particularly vital when it comes to cancer that has spread beyond the breast (metastatic). One hallmark of the Susan F. Smith Center for Women's Cancers is the integration of research and patient care, and the equal investment in both. At a basic level, scientists seek to understand the basic biology of how and why breast cancer can spread, and at a clinical level, clinician/scientists test potential therapies in patients. More than 30 clinical trials are now underway for women with metastatic breast cancer.

  • Harold J. Burstein, MD, PhD, provides an overview of the latest research in metastatic breast cancer presented at the San Antonio Breast Cancer Symposium in December 2019.
  • Research conducted through the Specialized Program of Research Excellence (SPORE) led by Eric Winer, MD, encompasses several metastatic breast cancer projects. This prestigious five-year grant funded by the National Cancer Institute includes projects aimed at identifying drug "targets" on breast cancer cells.

Here are some examples of our current metastatic breast cancer research advances.

Clinical Trials

    • Sara Tolaney MD, MPH, Erica Mayer, MD, Ian Krop, MD, PhD, and Eric Winer, MD, and their colleagues have launched a series of clinical trials of drugs designed to stimulate the immune system to attack metastatic breast cancer. Trials of immunotherapy approaches are currently underway for all three major breast cancer subtypes (ER-positive, HER2-positive, and triple-negative).
    • ER-positive breast cancer is typically treated with a combination of hormonal therapy with a targeted treatment, such as a CDK4/6 inhibitor (e.g. Ibrance, Kisquali, or Verzenio). Now, Sara Tolaney, MD, MPH, and Erica Mayer, MD, MPH, are leading clinical trials to test new ways to overcome resistance to CDK4/6 inhibitors, including combinations with immunotherapy or other targeted medications.
    • A phase 2 clinical trial led by Rachel Freedman, MD, MPH, and Nancy Lin, MD, found that the combination of two oral medications – neratinib (Nerlynx) and capecitabine (Xeloda) can be effective in patients with HER2-positive breast cancer that has spread to the brain. This is the first systemic treatment to gain recognition by the National Comprehensive Cancer Network (NCCN) guidelines for treatment of patients with brain metastases.  Multiple trials are currently underway to test additional treatments approaches for cancer that has spread to the brain.

Basic Research

    • Hormonal therapy, which deprives ER-positive breast cancers of estrogen, is part of after-surgery therapy for early ER-positive breast cancer, and is often successful at preventing return of the disease. However, ER-positive breast cancer can recur many years later, often at a site far from the original tumor. Researchers led by Myles Brown, MD, have discovered that breast tumor cells can carry an abnormal "receptor" for estrogen, potentially allowing them to grow even when estrogen is absent. Researchers hope to use this finding to guide the development of new drug agents.
    • Brown and his colleague Rinath Jeselsohn, MD, are studying a particularly promising class of drugs for metastatic, ER-positive breast cancers. Known as selective estrogen receptor degraders (or SERDs), they clamp onto the estrogen receptor and cause it to crumble, so the tumor cells no longer respond to estrogen.
    • Other research is focusing on the molecular makeup of breast tumors — the presence of genetically distinct cells within a single tumor. Tumors with the most "heterogeneity" — the greatest diversity of cell types within them — are often more likely to resist treatment and to metastasize. Researchers led by Kornelia Polyak, MD, PhD, have discovered that the fastest-proliferating cells within a tumor aren't necessarily the main drivers of tumor growth, suggesting that efforts to develop new drugs should focus on targeting the actual driver cells.
    • Up to 50 percent of HER2-positive breast cancers spread to the brain, but scientists have known little about how the process occurs. Recently a team of researchers including Nikhil Wagle, MD, Eric Winer, MD, Ian Krop, MD, PhD, Jean Zhao, PhD, Nancy Lin, MD, and Shom Goel, MD, PhD, found that approximately 12 percent of such tumors contain mutations that may explain why they don't respond well to the target drug trastuzumab, also known as Herceptin. Researchers in Zhao's lab have implanted patients' metastatic tissue into animal research models, making it possible to test various drugs to see which may be most effective against the disease.

Posted in: In Treatment, Medical/Science, Research, Treatment