A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (sac-TMT, MK-2870) as a Monotherapy and in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician’s Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less than 10 (TroFuse-011)
Recipient organisationNIHR University College London Hospitals Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodMar 2025 — Jul 2027
In plain English
AI plain-English summary
A new clinical trial is testing whether an antibody-drug conjugate, alone or with an immunotherapy, can help people with a hard-to-treat form of breast cancer live longer than standard chemotherapy. This matters because triple-negative breast cancer that lacks the PD-L1 protein—about half of all cases—has few effective treatment options. Standard chemotherapy often fails to shrink these tumours or keep them from spreading. The trial enrols roughly 1,000 patients whose cancer has returned after initial treatment or spread to other organs, and who have not received certain prior therapies. If successful, the combination of sacituzumab tirumotecan—which delivers a toxic drug directly to cancer cells—and pembrolizumab, which reactivates the immune system, could become a new standard of care for this patient group. That would mean more people living longer without their cancer growing, and potentially fewer side effects than with conventional chemotherapy. The trial runs for up to 5.5 years and compares three arms: the antibody-drug conjugate alone, the conjugate plus immunotherapy, and physician’s choice of chemotherapy.
View original technical description
Researchers are looking for new ways to treat PD-L1 negative triple negative breast cancer (TNBC). PD-L1 (a protein) found on cancer cells can help the cancer hide from the immune system. PD-L1 negative means the cancer has very little or no PD-L1 protein. TNBC (a breast cancer type) grows fast and is hard to treat. It is called triple negative because the cancer cells do not have receptors (proteins) for oestrogen, progesterone, or human epidermal growth factor 2 (HER2). Standard treatment for PD-L1 negative TNBC uses chemotherapy (medicine) to destroy cancer cells or stop them growing. However, the cancer may not respond (get smaller or go away).Sacituzumab tirumotecan (sac-TMT or MK-2870) and pembrolizumab are trial medicines. Sac-TMT is an antibody-drug conjugate (ADC) which attaches to a protein on cancer cells and delivers treatment to destroy those cells. Pembrolizumab (an immunotherapy) helps the immune system fight cancer.The main trial goal is to learn if people treated with sac-TMT alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to chemotherapy. About 1,000 participants at least 18 years old with PD-L1 negative TNBC will be in this trial. They will have cancer that has come back after treatment and cannot be removed by surgery, or cancer that has spread to other parts of the body and will have not received certain other treatments.Participants may receive pembrolizumab (up to 2 years), sac-TMT or chemotherapy into a vein as an intravenous (IV) infusion until their cancer grows or spreads, they or researcher decide to stop, they do not tolerate it, or trial ends.Participants will be randomly assigned to 1 of these treatment groups: • Group A: sac-TMT alone • Group B: sac-TMT with pembrolizumab • Group C: chemotherapy Participants may be in this trial for 5.5 years.
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