A Randomized, Double-Blind, Phase III Study of Pembrolizumab versus Placebo

A Randomized, Double-Blind, Phase III Study of Pembrolizumab versus Placebo in Combination with Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2–) Breast Cancer (KEYNOTE-756)

Study Type/Phase: Phase III
Status: Not Recruiting

The purpose of this trial is to evaluate the safety and effectiveness of Keytruda® (pembrolizumab) for patients with early stage breast cancer who need systemic treatment before and after surgery. Keytruda is an immunotherapy drug that has been approved by the FDA for other types of cancer. This trial will see how well Keytruda works when combined with chemotherapy and endocrine therapy, compared to these treatments alone, for this type of breast cancer. In this trial, Keytruda or a placebo will be added in a randomized fashion to the patient’s regular treatment regimen for breast cancer. This patient population is at higher risk for repeated occurrences of breast cancer and this trial gives them another treatment option.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • Localized, invasive breast ductal adenocarcinoma
  • ER+ and Her2- grade 3 breast cancer of ductal histology
  • Has enough tissue leftover from a previous biopsy, or willing to undergo additional core needle biopsy
  • ≥18 years of age
  • Adequate organ function, as determined by standard of care laboratory testing
  • Agrees to follow contraceptive guidance per study protocol
  • Has pneumonitis, or history of non-infectious pneumonitis that required treatment with steroids
  • Undergone excisional biopsy of the primary tumor and/or axillary lymph nodes, or sentinel lymph node biopsy
  • Has received prior treatment for breast cancer, or prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
  • Had additional invasive cancer requiring treatment in the last 5 years
  • Has a diagnosis of immunodeficiency; active autoimmune disease; history of active tuberculosis; or active infection requiring systemic therapy
  • Has significant cardiac disease; history of HIV infection or hepatitis B; or active hepatitis C

Principal Investigator

Jiali Li, MD, PhD

Sponsor

Merck Sharp & Dohme Corp.,
a subsidiary of Merck & Co., Inc.

NCT Number

NCT03725059

Contact

Kathy Miller, Clinical Research Coordinator
Taft Center for Clinical Research
650-962-4562
kathryn_miller@elcaminohealth.org

 

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