IRB #

STUDY00022191

Title

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)

Principal Investigator

Evie Hobbs

Study Purpose

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.

Medical Condition(s)

high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer

Eligibility Criteria

Person 18 years of age or older

Has a localized invasive breast ductal adenocarcinoma, confirmed by the local pathologist. Note: Inflammatory breast cancer is allowed.

Has centrally confirmed ER+/HER2-, Grade 3 breast cancer of ductal histology, according to the most recent American Society of Clinical Oncology/College of American Pathologist guidelines.

Has not received prior treatment for breast cancer

Age Range

18 - 101

Healthy Volunteers Needed

No

Duration of Participation

Study participants will receive 8 cycles of neoadjuvant study treatment and then will undergo surgery for their breast cancer. After surgery, participants will receive 9 cycles of study treatment and up to 10 years of variable endocrine therapy. Each cycle is 21 days long.

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
trials@ohsu.edu
503 494-1080

Sponsor

Merck Sharp & Dohme Corp.

Recruitment End

12/30/2031

Compensation Provided

No


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