MK-3475 + Chemotherapy in HR+/HER2- Metastatic Breast Cancer
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)
IRAS ID
1003689
Contact name
Melissa A. Clemens
Contact email
Sponsor organisation
Merck Sharp & Dohme LLC (MSD)
Eudract number
2020-005407-38
Clinicaltrials.gov Identifier
Research summary
Breast cancer is the most frequently diagnosed cancer and the leading cause of cancer deaths in women worldwide. In the United States, the estimated number of new cases and deaths from breast cancer in 2020 was approximately 279,100 and 42,690, respectively. Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2–) breast cancer (type of breast cancer) represents approximately 73% of all breast cancer cases.
The current standard of treatment for HR+/HER2- breast cancer includes the combination of endocrine therapy with CDK4/6 inhibitor (a class of medicines used to treat certain types of metastatic breast cancer). Once the cancer has progressed on endocrine therapy-based combinations the disease may be deemed endocrine therapy resistant. For these patients, chemotherapy is their only treatment option.
Pembrolizumab (MK-3475), is a monoclonal antibody (mAb) that targets programmed cell death 1 (PD1) which is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells meet cancer cells, PD1 becomes activated by programmed cell death ligands 1 and 2 (PDL1 and PDL2) which are proteins on the surface of cancer cells. The study drug pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers. Pembrolizumab is approved for several other types of cancer. Therefore, it is thought that chemotherapy combined with pembrolizumab will be favourable.
This is a phase 3 study which will last for approximately 76 months and will recruit approximately 800 male and female HR+/HER2 metastatic breast cancer (MBC) participants aged 18 and over. The purpose of the study is to evaluate the combination of chemotherapy plus pembrolizumab versus chemotherapy plus placebo. Participants will be randomly assigned in a 1:1 ratio to the two treatment arms.
The study is funded by Merck Sharp & Dohme Limited and will take place 7 NHS sites.
REC name
West of Scotland REC 1
REC reference
21/WS/0044
Date of REC Opinion
8 Jun 2021
REC opinion
Further Information Favourable Opinion