Sac-TMT + Pembro before chemotherapy in early TNBC or HR-low+/HER2-BC
Research type
Research Study
Full title
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer
IRAS ID
1011993
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer.
The standard treatment for both includes chemotherapy, immunotherapy, and then surgery.
Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy.
The main goals of this study are to learn if participants who receive sac-TMT, pembrolizumab (an immunotherapy), and chemotherapy:
• Have fewer cancer cells found in the tumours and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy
• Live longer without the cancer growing, spreading, or coming back compared to participants who receive only pembrolizumab with chemotherapy
About 2,400 participants will be in this study. Participants will be at least 18 years old and:
• Have high-risk, early-stage TNBC or HR low positive/HER2 negative breast cancer that has not been treated before
• Do not have cancer that has spread to other parts of the body
Everyone will receive 2 or 3 of these treatments and have surgery to remove the breast cancer:
• Sac-TMT, the study medicine, once every 2 weeks
• Pembrolizumab, once every 3 weeks before surgery and once every 3 or 6 weeks after surgery
• Chemotherapy:
o Paclitaxel and carboplatin, every week
o Doxorubicin or epirubicin and cyclophosphamide once every 3 weeks before surgery and every 2 or 3 weeks after surgery
Researchers will choose the treatment after surgery, based on how the cancer responds to treatment given before the surgery.
Both the participants and researchers will know which study treatment they are getting. During the study, participants will give urine, blood, and tumour samples, have imaging tests and check their heart. Participants will also have physical examinations.
Participants may be in this study for up to 10 years.REC name
London - Chelsea Research Ethics Committee
REC reference
25/LO/0475
Date of REC Opinion
22 Jul 2025
REC opinion
Further Information Favourable Opinion