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Research and Clinical Trials

  • The team at DF/BWCC offers more clinical trials for breast cancer patients with brain metastases than any other center in the world. Our physicians and researchers are on the forefront of developing more effective treatments options for patients living with brain metastases.

    Should you participate in a clinical trial?
    In recent years, clinical trials – some of which have been led at DF/BWCC – have led to many advances in the care and treatment of people with breast brain metastases. Today we have access to a range of options beyond radiation and surgery, including targeted immunotherapy and systemic treatments.

    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.
    • 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.

    Speak to your doctor about your clinical trial options. Learn more about clinical trials and whether participating in a clinical trial is right for you.

  • Research advances in Breast Cancer with Brain Metastases
    In addition to providing expert care for patients with breast cancer, DF/BWCC physician scientists have been on the forefront of developing more effective treatments options for patients living with brain metastases for many years.

    DF/BWCC investigators led the first clinical trials of HER2-targeted therapy for the treatment of breast cancer brain metastases. A combination of Lapatinib (Tykerb) with capecitabine (Xeloda) was the first targeted, systemic treatment to demonstrate effectiveness in the brain in clinical trials. DF/BWCC investigators led the very first trials of this regimen, which is now included in national and international guidelines for treatment of HER2-positive breast cancer that has spread to the brain.

    The combination of Neratinib (Nerlynx) and capecitabine (Xeloda) can also be effective in the treatment of HER2-positive breast cancer brain metastases.  Dana-Farber investigators led the trial leading to the inclusion of this treatment regimen in national treatment guidelines.

    DF/BWCC physicians have led national and international efforts to improve the design of clinical trials for patients with breast cancer that has spread to the brain. Close collaborations between laboratory scientists and clinical investigators has led to a series of exciting new clinical trials currently recruiting patients.

    Current Clinical Trials

    • Neratinib for Patients with HER2-Positive Breast Cancer with Brain Metastases
      This study evaluates the response of the central nervous system to neratinib (Nerlynx®)-based treatments in patients with HER2-positive breast cancer with brain metastases.
      Video: Study of Neratinib for Patients with HER2-Positive Breast Cancer with Brain Metastases
    • GDC-0084 with Trastuzumab in HER2-Positive Breast Cancer with Brain Metastases
      This study evaluates the efficacy, safety, and tolerability of PI3K inhibitor GDC-0084 in combination with trastuzumab for the treatment of central nervous system metastases in patients with HER2-positive metastatic breast cancer.
      Video: Study of GDC-0084 with Trastuzumab in HER2-Positive Breast Cancer with Brain Metastases
    • Atezolizumab with Pertuzumab and Trastuzumab in HER2-Positive Metastatic Breast Cancer
      This study evaluates the efficacy, safety, and tolerability of atezolizumab in combination with pertuzumab and high-dose trastuzumab for the treatment of central nervous system metastases in patients with HER2-positive metastatic breast cancer.
    • Tesetaxel with Capecitabine vs Capecitabine Alone in HER2-Negative, HR-Positive, Locally Advanced or Metastatic Breast Cancer (CONTESSA)
      This study compares the efficacy, safety, and tolerability of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone in patients with HER2-negative, HR-positive, locally advanced or metastatic breast cancer previously treated with a taxane.
    • Atezolizumab with Stereotactic Radiation in Triple-Negative Breast Cancer with Brain Metastasis
      This study evaluates the efficacy, safety, and tolerability of atezolizumab in combination with stereotactic radiation in patients with triple-negative breast cancer with brain metastases.
    • Whole-Brain Radiation vs. Stereotactic Radiation for Patients with 5-20 Brain Metastases
      For most patients with greater than four brain metastases, whole brain radiation, in which the entirety of the brain is treated with radiation, has historically been the standard treatment. Stereotactic radiation, in which a high dose of radiation is focused on the specific lesion(s) to be treated, with minimal dose to the surrounding brain, is an approach frequently used in patients with one to four brain metastases. This study compares the efficacy of hippocampal-sparing whole brain radiation to stereotactic radiation in patients with 5-20 brain metastases and examines the quality of life of these patients following treatment.
    • Screening MRI of the Brain in Metastatic Breast Cancer or Inflammatory Breast Cancer
      This study aims to assess the impact of screening brain MRI on neurologic quality of life in patients with:
      • HR+/HER2-negative and HER2-positive breast cancer who initiate first-line or second-line chemotherapy for extracranial metastatic disease or unresectable local recurrence
      • Triple-negative breast cancer who initiate first-line or second-line chemotherapy for extracranial metastatic disease or unresectable local recurrence
      • Inflammatory breast cancer who are treated with curative intent.
    • NKTR-102 in Breast Cancer with Brain Metastases
      This study compares the effects of topoisomerase I inhibitor polymer conjugate NKTR-102 with existing single-agent therapies. Physicians may select from the following list of seven intravenous (IV) therapies: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.

    Ask your provider if any of these clinical trials may be right for you.

    Search DF/BWCC clinical trials.

    Research team

    Hugo Aerts, PhD
    Ayal Aaron Aizer, MD, MHS
    Omar Arnaout, MD
    David Barbie, MD
    Linda Bi, MD, PhD
    Daniel Cagney, MD
    Ugonma Chukwueke, MD
    Rachel Freedman, MD, MPH
    Alexandra Golby, MD
    Daphne A. Haas-Kogan, MD
    Raymond Y. Huang, MD, PhD
    Sheheryar Kabraji, MB, ChB
    Ian E. Krop, MD, PhD
    Benjamin Izar, PhD, MD
    Jose Pablo Leone, MD
    Eudocia Quant Lee, MD
    Keith Ligon, MD, PhD
    Nancy U. Lin, MD
    J. Ricardo McFaline-Figueroa, MD, PhD
    Heather Parsons, MD, MPH
    Pier Paolo Peruzzi, MD, PhD
    Rifaquat Musaffa Rahman, MD
    Sandro Santagata, MD, PhD
    Timothy Smith, MD, PhD
    Shyam Tanguturi, MD
    Sara Tolaney, MD, MPH
    Eric P. Winer, MD
    Jean Zhao, PhD