Investigational Agents as Therapy for Early Triple-Neg. Breast Cancer

• Research type

  Research Study

• Full title

  A Phase 2, Umbrella Study to Evaluate the Safety, Tolerability, and Clinical Activity of Investigational Agents for Newly Diagnosed, High-Risk, Early-Stage Triple- Negative Breast Cancer

• IRAS ID

  1011460

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Researchers are looking for new ways to treat triple-negative breast cancer (TNBC).
  The standard treatment for TNBC is pembrolizumab and chemotherapy before surgery. After surgery, pembrolizumab is continued by itself.
  Researchers want to know if giving boserolimab (the trial treatment, also known as MK-5890) with standard treatment before surgery can help treat TNBC. The goals of this trial are to learn:
  • About the safety of boserolimab given with standard treatment before surgery and if participants tolerate it
  • How many participants have no signs of cancer in the tumours and lymph nodes removed during surgery

  About 100 participants with newly diagnosed, high-risk, early-stage TNBC will be in this trial. Participants will be 18 years and older and:
  • Can have surgery to remove breast cancer
  • Do not have certain heart problems

  Everyone in the trial will receive the standard treatment, which includes:
  • Pembrolizumab, given as an intravenous (IV) infusion every 3 weeks before surgery and
  every 3 or 6 weeks after surgery
  • 2 types of chemotherapy, as an IV infusion before surgery
  o One type every week for the first 3 months
  o A different type every 3 weeks for the next 3 months
  • Surgery
  Participants may also receive boserolimab as an IV infusion every 6 weeks before surgery. After surgery, the trial doctor may choose to give participants more treatment, if it is needed, such as:
  • Radiation therapy - uses beams of intense energy (similar to X-rays) to shrink or get rid of tumours
  • Capecitabine - a chemotherapy
  • Olaparib - a targeted therapy for tumours

  Both the participants and researchers will know which treatments they are getting. During the trial, participants will give urine, blood, and tumour samples and have imaging tests. Participants will also have physical examinations. Participants may be in this trial for up to 6 years.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  25/SC/0038

• Date of REC Opinion

  23 Apr 2025

• REC opinion

  Further Information Unfavourable Opinion