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Center for BRCA and Related Genes Clinical Trials

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    An important priority of our Center is to provide novel therapies for patients with BRCA-mutated and BRCA-related cancers through clinical trial participation. The Center offers novel resources and therapies in the form of clinical trials — spanning early and late phases of therapy, risk reduction (prevention), and early detection, as well as quality of life and survivorship — to patients and families with BRCA-mutated cancers.

    For patients and families with Lynch syndrome and Li Fraumeni-related cancers, more information on trials and therapies is available from the Lynch Syndrome Center and the Li-Fraumeni Syndrome and TP53 Center at Dana-Farber.

    Patients can enter trials that are conducted:

    Therapeutic Trials for Patients with BRCA-mutated and BRCA-related Cancers

    For treatment, Dana-Farber boasts one of the largest portfolios of clinical trials nationally addressing novel therapeutics for patients with inherited and acquired mutations in BRCA1/2 and related DNA-repair genes in ovarian, breast, pancreatic, prostate, and other cancers.

    A Special Focus on Resistance

    Dana-Farber has played a critical role in the development and eventual FDA approval of PARP inhibitors for ovarian, breast, pancreatic, and prostate cancers; we are also evaluating strategies for patients with tumors that are intrinsically resistant or that have developed resistance to PARP inhibitors. Our center has a special focus on patients who are heavily pretreated and whose cancers have developed resistance to chemotherapy, targeted agents, and DNA repair inhibitors such as PARP inhibitors.

    We are examining agents such as ATR inhibitors, WEE1 inhibitors, and other cell cycle checkpoint inhibitors, as well as targeted agents including PI3K inhibitors, CDK inhibitors, MAPK pathway inhibitors, and HSP90 inhibitors, alone or in combination with immunotherapy such as PD-1/PD-L1 inhibitors. We are also using PARP inhibitors to further augment the activity of antibody-drug conjugates and immunotherapy. Many of our studies are investigator-initiated, based on preclinical data developed at Dana-Farber using various disease models such as patient-derived xenograft models, organoid models, and genetically-engineered mouse model platforms.

    Eligible participants for these clinical trials include not only patients with BRCA-mutated cancers, but also patients with inherited and acquired somatic (tumor-only) mutations in other BRCA-related genes such as PALB2, RAD51C, and others.

    Risk Reduction (Prevention) Trials

    For cancer risk reduction (prevention), the Center for Cancer Genetics and Prevention is home to several clinical trials to evaluate the potential of different strategies to delay or prevent the development of breast or ovarian cancers in BRCA-mutation carriers. Various novel approaches are being explored including vaccines, selective estrogen receptor degraders, and various targeted agents such as the RANKL inhibitor denosumab.

    Early Detection

    The early detection MiDe Study (MicroRNA for early Detection) of ovarian cancer has been launched to evaluate the potential of circulating serum microRNAs (miRNAs) as a screening test for ovarian cancer in healthy BRCA-mutation carriers. Not all BRCA carriers may develop cancer, and more importantly we don't know when the malignant tumor will develop. Dipanjan Chowdhury, PhD, and Kevin Elias, MD, have developed a non-invasive diagnostic test to monitor BRCA carriers and assess their risk of developing ovarian cancer. In collaboration with Judy Garber, MD, MPH, this study has been initiated to formally develop a screening test for early detection of ovarian cancer in families with mutations in BRCA and BRCA-related genes. Analogous efforts for the early detection of cancer are ongoing through the Li-Fraumeni Syndrome and TP53 Center at Dana-Farber.

    What to Expect

    At Dana-Farber, your treatment team is based in one of our specialized disease centers for different cancer types. You may be referred to the BRCA Center to discuss the possibility of participating in a clinical trial, but you will remain under the care of your original team.

    When you come to the BRCA Center for a clinical trial, we will provide you with specific information about what your participation will entail. We will make sure you, your family, and your treatment team understand all aspects of your involvement in the trial.

    The BRCA Center's staff is devoted to pursuing excellence in the safe conduct of clinical trials for cancer, with compassion and respect for everyone involved.