A Phase II Study of Olaparib and Pembrolizumab in People with Triple-Negative Breast Cancer or Hormone Receptor-Positive HER2-Negative Breast Cancer with Certain Genetic Mutations


Full Title

Phase II of Neoadjuvant Olaparib in Combination with Pembrolizumab in Patients with Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer And Germline Mutations in DNA Damage Repair Genes


The purpose of this study is to assess the safety and effectiveness of giving pembrolizumab immunotherapy and olaparib (a drug called a PARP inhibitor) before surgery in women who have breast cancer and certain inherited genetic mutations. The patients in this study will have breast cancer that contains no receptors for estrogen, progesterone, or the HER2 protein (“triple-negative breast cancer” or TNBC) OR contains hormone receptors but not HER2 (hormone receptor-positive HER2-negative breast cancer). 

Pembrolizumab works by boosting the ability of the immune system to detect and destroy cancer cells. Olaparib destroys cancer cells by preventing them from repairing damage to the genetic information that helps them survive and grow. Pembrolizumab is given intravenously (by vein) and olaparib is taken orally (by mouth).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have stage I-III TNBC or hormone receptor-positive HER2-negative breast cancer that has not yet been treated and will be surgically removed.
  • Patients must have inherited a mutation in the BRCA1, BRCA2, PALB2, RAD51C, or RAD51D gene.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.


For more information and to ask about eligibility for this study, please contact the office of Dr. Ayca Gucalp at 646-888-4536.




Phase II (phase 2)




ClinicalTrials.gov ID