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) - Phase III study of pembrolizumab for high-risk early-stage ER+/HER2– breast cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2–) Breast Cancer
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 1140
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

October 19, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Type of Participant and Disease Characteristics
•1\. Participant has a localized invasive breast ductal adenocarcinoma, confirmed by the local pathologist, that includes either T1c\-T2 (tumor size \=2 cm), clinical node stage (cN)1\-cN2, or T3\-T4, cN0\-cN2\.
•2\. 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.
•3\. Provides a new or recently obtained core needle biopsy, consisting of multiple cores, taken from the primary breast tumor(s) for central determination of HR status (ER and progesterone receptor), HER2, and PD\-L1 status.
•Demographics
•4\. Is a male or female \=18 years of age on the day of signing informed consent.
•5\. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to initiation of study treatment
•Male participants:
•6\. A male participant must agree to use a contraception as detailed in Appendix 3 of the protocol during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment and refrain from donating sperm during this period.
•Female participants:

•Medical Conditions
•1\. Has a history of non\-infectious pneumonitis that required treatment with steroids or has current pneumonitis.
•2\. Has breast cancer with lobular histology.
•3\. Has bilateral invasive breast cancer.
•4\. Has metastatic (Stage IV) breast cancer.
•5\. Has multi\-centric breast cancer (presence of more than 1 tumor in different quadrants of the breast).
•6\. Has any of the following clinical lymph node staging per current AJCC staging criteria for breast cancer staging based on radiological and/or clinical assessment: cN3, cN3a, cN3b, or cN3c.
•7\. Has ER–, progesterone receptor positive breast cancer.
•8\. Participants who have undergone excisional biopsy of the primary tumor and/or axillary lymph nodes or have undergone sentinel lymph node biopsy prior to study treatment.
•9\. Has a known additional, invasive, malignancy that is progressing or required active treatment in the last 5 years.