A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
This research study is investigating new treatments for people with hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer that has spread or cannot be removed by surgery. The study aims to compare an investigational drug called sacituzumab tirumotecan, given by itself or in combination with another drug called pembrolizumab, against standard chemotherapy options chosen by the doctor. The main goal is to find out if these new treatments can stop or slow down the cancer's growth for longer than current standard care. This is a Phase 3 study, meaning it's in the later stages of testing new treatments, involving a larger number of patients.
At a glance
What is this study about?
This study is looking at new ways to treat a specific type of breast cancer: hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer that is advanced, meaning it has spread to other parts of the body (metastatic), or can't be removed by surgery (unresectable locally advanced). For people with this type of cancer, standard treatments might not always work as well or for as long as hoped.
The researchers want to compare a new drug called sacituzumab tirumotecan – either on its own or together with another drug called pembrolizumab – against the standard chemotherapy treatments that doctors usually offer. The main hope is that these new treatments might be better at stopping the cancer from growing or spreading further, which is known as progression-free survival.
This kind of research is very important because it helps us find new and potentially more effective options for people living with advanced breast cancer. By participating in this study, you could help doctors learn more about these new treatments and improve care for future patients. All treatments in this study are carefully monitored by a team of medical professionals.
Key takeaways
- Investigates new treatments for advanced HR+/HER2- breast cancer.
- Compares investigational drugs against standard chemotherapy.
- Aims to find treatments that better control cancer growth.
- Participation involves regular clinic visits, tests, and follow-up.
- You have the right to withdraw from the study at any time.
Who may be eligible?
To join this study, you need to have a specific type of breast cancer that's hormone receptor-positive (HR+) and HER2-negative (HER2-), and it should be advanced or spread, not able to be removed by surgery.
You would also need to show that your cancer has started to grow again after trying at least one hormone treatment, including one that was combined with a particular type of drug called a CDK4/6 inhibitor. You should be in good enough health to be considered for chemotherapy, with good general physical ability and organ function.
There are also some reasons why you might not be able to join. For example, if your cancer could still be cured with existing treatments, or if you had a very quick return of cancer after earlier chemotherapy (within 6 months). Also, if you have very severe symptoms from cancer spreading to your organs, or if you've already had chemotherapy for your advanced breast cancer, you might not be eligible. Certain active infections, autoimmune diseases, or lung conditions might also exclude you.
- Do you have HR+/HER2- breast cancer that has spread or can't be surgically removed?
- Has your cancer progressed after hormone treatment, including one combined with a CDK4/6 inhibitor?
- Are you generally well enough to be considered for chemotherapy?
- Have you NOT received chemotherapy specifically for your advanced breast cancer?
- Do you have good overall organ function?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you'll be assigned by chance (like flipping a coin) to one of three treatment groups: receiving sacituzumab tirumotecan alone, sacituzumab tirumotecan with pembrolizumab, or one of the standard chemotherapy treatments chosen by your doctor (paclitaxel, nab-paclitaxel, capecitabine, or liposomal doxorubicin).
Your treatment will involve regular visits to the clinic for drug administration, typically given as an infusion. During these visits, you'll have various tests like blood samples, physical exams, and scans (like CT or MRI) to check how well the treatment is working and to monitor for any side effects. The exact schedule of visits and tests will be explained in detail by the study team.
The treatment will continue for as long as it is benefiting you and you are tolerating it well. Even after you stop the study treatment, there will be follow-up appointments, usually less frequent, to monitor your health in the long term. The total duration of your participation, including follow-up, will be clearly explained by the research team.
Potential risks and benefits
Locations (258)
- Ironwood Cancer & Research Centers ( Site 0066)Chandler, United States· Recruiting
- Banner MD Anderson Cancer Center-Oncology ( Site 0004)Gilbert, United States· Recruiting
- Providence Medical Foundation-Oncology ( Site 0020)Fullerton, United States· Recruiting
- Moores Cancer Center ( Site 0059)La Jolla, United States· Active not recruiting
- Cancer and Blood Specialty Clinic ( Site 0001)Los Alamitos, United States· Recruiting
- University of Colorado Anschutz Medical Campus ( Site 0061)Aurora, United States· Recruiting
- UCHealth Cherry Creek Medical Center ( Site 0094)Denver, United States· Recruiting
- University of Colorado Health - Highlands Ranch Hospital ( Site 0095)Highlands Ranch, United States· Recruiting
- Yale Cancer Center ( Site 0060)New Haven, United States· Recruiting
- Stamford Hospital ( Site 0049)Stamford, United States· Recruiting
- AdventHealth Altamonte Springs ( Site 0021)Altamonte Springs, United States· Recruiting
- University of Florida College of Medicine ( Site 0063)Gainesville, United States· Recruiting
+246 more sites — see the official record for the full list.
Common questions
What kind of breast cancer is this study for?
This study is for advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-), and has either spread or cannot be removed by surgery.
What are the new drugs being tested?
The new drugs being tested are sacituzumab tirumotecan, which is being studied alone and in combination with pembrolizumab.
How will I know if I'm getting the new drug or standard treatment?
You will be randomly assigned to one of the treatment groups, but your doctor will not choose which one; it's like drawing lots. You will be told which treatment group you are in.
What is 'progression-free survival'?
Progression-free survival means the length of time during and after treatment that you live without the cancer getting worse or spreading.
Who can I talk to if I have more questions?
The study team (doctors, nurses, and research staff) will be available to answer all your questions and provide detailed information.
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?
Discussion
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