A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
This study is for people with certain types of early-stage, high-risk breast cancer, including triple-negative breast cancer and HR-low positive/HER2-negative breast cancer. Researchers want to improve how these cancers are treated. The study will test a new medicine called sacituzumab tirumotecan (Sac-TMT), which is a "targeted therapy." This type of treatment is designed to specifically attack cancer cells. Sac-TMT will be given alongside other common cancer medicines like pembrolizumab and chemotherapy. The main goals are to see if adding Sac-TMT reduces the amount of cancer found in tumours and lymph nodes after surgery, and if it helps people live longer without their cancer growing or coming back, compared to those who just receive pembrolizumab and chemotherapy.
At a glance
What is this study about?
This study is looking for new and better ways to treat certain types of breast cancer that are caught early but are considered "high-risk." High-risk means there's a higher chance the cancer might grow or return after treatment. The types of breast cancer included here are called triple-negative breast cancer (TNBC) and a specific kind of HR-low positive/HER2-negative breast cancer. These names simply describe what's happening (or not happening) with certain proteins on the cancer cells, which helps doctors understand how the cancer might behave and what treatments might work best.
The new medicine being tested is called sacituzumab tirumotecan, or Sac-TMT for short. This is an advanced type of drug that doctors call a "targeted therapy." Unlike traditional chemotherapy, which can affect many cells in the body, a targeted therapy is designed to attack cancer cells more specifically, often by finding and attaching to certain features unique to those cells. The researchers want to know if adding Sac-TMT to other standard treatments, like pembrolizumab and chemotherapy, can make a bigger difference.
The main things the study hopes to find out are two-fold. Firstly, they want to see if people who get Sac-TMT, along with pembrolizumab and chemotherapy, have less cancer in their tumours and surrounding lymph nodes when they are removed during surgery. Secondly, and very importantly, they want to know if this combination of treatments helps people live longer without their cancer growing, spreading, or coming back, compared to those who receive only pembrolizumab and chemotherapy. This could potentially offer a new, more effective way to treat these breast cancers.
Key takeaways
- Tests a new medicine (Sac-TMT) for high-risk early breast cancer.
- Aims to reduce cancer and improve survival without new growth.
- Involves regular check-ups, medication, and surgery.
- For specific types of breast cancer: triple-negative or HR-low+/HER2-negative.
- Participation is voluntary; you can withdraw anytime.
Who may be eligible?
This study is for adults, aged 18 or older, who have early-stage, high-risk breast cancer that hasn't spread to other parts of their body (not metastatic). Your cancer must be either triple-negative or the specific type called HR-low positive/HER2-negative. This will be confirmed by doctors testing a small sample of your tumour.
To be considered, you can't have received any previous treatment for your current breast cancer, such as radiation, surgery to remove the primary tumour, or chemotherapy. You also can't have had certain other experimental cancer medicines in the past four weeks or specific types of targeted therapies before.
Doctors will also check your general health, including blood tests to ensure your body’s organs are working well and that you have a good 'performance status,' meaning you're generally able to carry out daily activities without too much difficulty.
- Are you 18 years old or older?
- Have you been diagnosed with high-risk, early-stage breast cancer that hasn't spread?
- Has your breast cancer been identified as triple-negative, or HR-low positive/HER2-negative?
- Have you NOT received any previous treatment (like surgery, radiation, or chemotherapy) for this breast cancer diagnosis?
- Are you generally well and able to manage daily activities?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
Taking part in this study means you would receive a combination of medicines: the study medicine (sacituzumab tirumotecan), pembrolizumab, and standard chemotherapy drugs like carboplatin, paclitaxel, doxorubicin, epirubicin, cyclophosphamide, or capecitabine. The exact combination will depend on which group you are assigned to. These medicines are typically given through an IV (a drip into your vein) in a clinic or hospital setting.
Throughout the study, you would have regular visits for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. Before starting treatment, a small tissue sample (biopsy) of your tumour will be taken. After a period of treatment with the study drugs, you would likely have surgery to remove the tumour and any affected lymph nodes. Doctors would then examine these removed tissues to see the effects of the treatment.
After surgery, you might continue with some treatments or enter a follow-up period where your health is monitored for a longer time, even after active treatment has finished. The total duration of active treatment and follow-up will vary for each person but could last for several months or even years to fully understand the long-term effects.
Potential risks and benefits
Locations (292)
- Banner MD Anderson Cancer Center ( Site 0066)Gilbert, United States· Recruiting
- Mayo Clinic Cancer Center ( Site 0034)Phoenix, United States· Recruiting
- University of Arizona Cancer Center ( Site 0035)Tucson, United States· Recruiting
- Roy and Patricia Disney Family Cancer Center ( Site 0055)Burbank, United States· Recruiting
- Providence Medical Foundation ( Site 0080)Fullerton, United States· Recruiting
- Hoag Memorial Hospital Presbyterian ( Site 0010)Newport Beach, United States· Recruiting
- Helios Clinical Research ( Site 0061)Whittier, United States· Recruiting
- Intermountain Health Cancer Center Saint Joseph ( Site 0062)Denver, United States· Recruiting
- Rocky Mountain Cancer Centers (RMCC) ( Site 8006)Denver, United States· Recruiting
- Intermountain Health St. Mary's Regional Hospital ( Site 0054)Grand Junction, United States· Recruiting
- AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0044)Altamonte Springs, United States· Recruiting
- Florida Cancer Specialists - South ( Site 7004)Fort Myers, United States· Recruiting
+280 more sites — see the official record for the full list.
Common questions
What is 'high-risk' early-stage breast cancer?
It means the cancer is found early (not spread far) but has a higher chance of coming back or getting worse, based on its characteristics.
What is sacituzumab tirumotecan?
It's a new type of "targeted therapy" medicine designed to specifically attack breast cancer cells while trying to spare healthy cells.
Will I definitely get the new medicine?
You might get the new medicine with other standard treatments, or you might get only the standard treatments. This is decided by chance to compare the effects.
How long does the study last?
The active treatment phase and follow-up can last for several months to years, involving regular clinic visits, tests, and monitoring.
Can I stop participating if I want to?
Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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