MK-2870 with or without pembro in HR+/HER2- metastatic breast cancer

• Research type

  Research Study

• Full title

  An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician’s Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer

• IRAS ID

  1009135

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06312176

• Research summary

  Researchers are looking for new ways to treat people with metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor-2 negative (HER2-) breast cancer. Metastatic means the cancer has spread to other parts of the body.

  Researchers want to learn if MK-2870 (the trial medicine), given alone or with pembrolizumab, works to treat HR+/HER2- breast cancer that has already been treated with hormone therapy. MK-2870 is a targeted therapy, which is a treatment that works on specific types of cancer cells to stop them from growing. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer.

  About 1200 people, aged 18 and older, with breast cancer will be in this trial and:
  • Have metastatic HR+/HER2- breast cancer that cannot be removed with surgery
  • Had the cancer grow or spread during treatment with hormone therapy
  • Have not received chemotherapy for the metastatic cancer

  People will be assigned to 1 of 3 treatment groups (3:3:2 ratio):
  • Group A - MK-2870 alone
  • Group B - MK-2870 and pembrolizumab
  • Group C - chemotherapy

  Both the people in the trial and the researcher will know which trial treatment a person is getting (open-label trial).

  People will receive MK-2870 through a needle into a vein as an intravenous (IV) infusion every 2 weeks. They will receive pembrolizumab by IV infusion every 6 weeks for about 2 years. They will receive chemotherapy by IV infusion or by mouth, based on the type. Timing of chemotherapy treatments will also depend on type. People will receive treatment until they cannot tolerate it, the cancer grows or spreads, or they stop the trial.

  People may give urine samples, have blood, tumour, and imaging tests, have physical examinations, and answer questions during the trial. A person may be in this trial for up to 7 years.

• REC name

  Wales REC 2

• REC reference

  24/WA/0030

• Date of REC Opinion

  25 Mar 2024

• REC opinion

  Further Information Favourable Opinion