Conditions
Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms, Triple Negative Breast Neoplasms
Trial Purpose
Researchers are looking for new ways to treat types of breast cancer that are both:
* High-risk, which means that the cancer may have a higher chance of getting worse or coming back after treatment
* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast. The two types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have a zero or low amount of a protein called HER2 and other proteins that attach to the hormones oestrogen or progesterone.
Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.
The main goals of this study are to learn whether people who receive sac-TMT, pembrolizumab and chemotherapy:
* Have fewer cancer cells found in the tumours and lymph nodes that are removed during surgery compared to those who receive only pembrolizumab and chemotherapy
* Live longer without the cancer growing, spreading or coming back, compared to people who receive only pembrolizumab with chemotherapy
NATIONAL TRIAL REFERENCE NUMBER
NCT06966700
EU CT
2024-520190-12-00
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Resources
Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Age Range
18+
Sex
All
About The Trial
Trial Phase
Trial Phase 3
Tests the medicine or vaccine in large groups of trial participants (from several hundred to several thousand). For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics or doctors’ offices.
Trial start and end dates
- Actual study start date 30 June 2025
- Estimated primary completion date 23 March 2033
- Estimated study completion date 29 December 2034
Trial locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risks and possible benefits are for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about