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Research & Clinical Trials > Study Search Tool > Pembrolizumab in Advanced BRCA-mutated Breast Cancer

Pembrolizumab in Advanced BRCA-mutated Breast Cancer

This study is open to:

Patients with metastatic breast cancer who:

  • are positive for a BRCA mutation.
  • had their breast cancer progress on, or after prior therapy for metastatic disease or locally advanced disease.
This study is not open to:

Patients are excluded if they: 

  • are currently participating or have participated using an investigational agent in the last 30 days 
  • have had treatment within 3 weeks prior to starting study.
  • are receiving systemic steroid therapy or any other form of immunosuppression within three days of starting study.
  • have received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • have had prior cancer diagnosis except if there is no evidence of disease recurrence for 5 years since treatment.
  • have active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate if they are stable for at least four weeks.
  • have active autoimmune disease that has required systemic treatment in the past 2 years.
Pembrolizumab in Advanced BRCA-mutated Breast Cancer

Immunotherapy for Advanced BRCA Breast Cancer

Clinicaltrials.gov identifier:
NCT03025035

Treatment:
Breast

Study Contact Information

The study is being conducted by researchers at Cedars-Sinai Medical Center. Contact Bethany Wendel, RN, Research Coordinator by phone at 310-967-4339 or by email.       

About the Study

This trial will evaluate the use of the immunotherapy agent, Pembrolizumab, (Keytruda) in people with advanced breast cancer associated with a BRCA mutation. The main objective is to examine overall response rate of pembrolizumab single agent therapy in advanced BRCA-mutated breast cancer.

Visit clinicaltrials.gov for more information.  

Type of Study

This is an open-label, single-arm study.

  • The study has one arm. This means that all patients in the study will receive the same treatment, pembrolizumab.

What the Study Entails

  • All participants will receive pembrolizumab administered intravenously every 21 days. 

Study Lead Investigator

Principal Investigator: Monica Mita, MD, Cedars-Sinai Medical Center

 

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