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Randomized Open-Label Phase 3 Study of Single Agent Pembrolizumab versus Single Agent Chemotherapy per Physician’s Choice for Metastatic Triple Negative Breast Cancer (mTNBC) – (KEYNOTE-119)

Clinical Trial Details

This clinical trial is for women with metastatic triple-negative breast cancer (mTNBC). This means that the three most common types of receptors (estrogen, progesterone, and human epidermal growth factor [HER2]) known to fuel most breast cancer growth are not present in their cancer.

The purpose of this study is to test the safety, tolerability and anti-tumor activity of the research study drug, Pembrolizumab (MK-3475) compared to other chemotherapy drugs of physician’s choice (which includes Capecitabine, Eribulin, Gemcitabine, or Vinorelbine) in subjects with Metastatic Triple-Negative Breast Cancer (mTNBC).

Possible treatment regimens:

  • Pembrolizumab or ONE drug from the following:  Capecitabine, Eribulin, Gemcitabine, Vinorelbine
  • Each pembrolizumab dose (200mg via IV inusion) is given every 3 weeks
  • Patients will receive treatment for approximately 35 weeks

Key Eligibility: 
  • Open to women at least 18 years of age or older
  • Must have a diagnosis of metastatic triple-negative breast cancer (mTNBC)
  • You cannot be in the study if: You had chemotherapy or radiation therapy within the previous 2 weeks
  • Detailed eligibility reviewed when you contact the study team

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Contact

Silvana Kim
sik7006@med.cornell.edu

Primary Investigator

Linda Vahdat, M.D.

Protocol ID(s)

Weill Cornell Medicine IRB #:

1511016755

Sponsor:

E7389-M001-218

ClinicalTrials.gov:

NCT02555657

Status:

Open to Enrollment

Age Group

Adult

Sponsor

Disease

Drug/Device

Drug

Study Type

Phase