Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
This research study is for people with triple-negative breast cancer. This is a specific type of breast cancer that doesn't have certain hormone receptors, making it harder to treat with some common therapies. The study focuses on patients who have already had chemotherapy before surgery (called neoadjuvant therapy) but still had some cancer remaining after their operation (didn't achieve a 'complete response'). The main goal is to compare a new drug combination – sacituzumab tirumotecan plus pembrolizumab – with the usual care chosen by their doctor. Researchers want to find out if this new combination is more effective at preventing the cancer from returning, a measure called 'invasive disease-free survival'. Pembrolizumab is already used in this setting, and sacituzumab tirumotecan is a newer type of targeted therapy. The study will also look at safety and side effects.
At a glance
What is this study about?
This clinical trial is designed for individuals in the UK who have been diagnosed with triple-negative breast cancer. This particular type of breast cancer is known for being aggressive and doesn't respond to hormone therapy or treatments targeting HER2 receptors. Many patients with triple-negative breast cancer receive initial chemotherapy (called neoadjuvant therapy) before surgery to shrink the tumour. However, sometimes, even after this treatment and surgery, some cancer cells might still be present.
This study aims to discover if a new treatment combination is better than current standard care for patients who had some cancer remaining after their initial neoadjuvant therapy and surgery. The new combination being tested is called sacituzumab tirumotecan (often referred to by its study code, MK-2870) alongside pembrolizumab. Pembrolizumab is an immunotherapy drug already used in some breast cancer treatments, and sacituzumab tirumotecan is a targeted drug that delivers chemotherapy directly to cancer cells. The 'standard care' option in this study could include pembrolizumab on its own or pembrolizumab combined with another chemotherapy drug called capecitabine.
The main question this study hopes to answer is whether the combination of sacituzumab tirumotecan and pembrolizumab can prevent the cancer from returning for a longer period compared to the doctor's choice of standard treatment. This is what we call 'invasive disease-free survival'. Researchers will also carefully monitor any side effects or unwanted reactions to the treatments to ensure they are safe for patients.
Key takeaways
- This study is for triple-negative breast cancer patients.
- It's for people who had some cancer remaining after pre-surgery treatment and surgery.
- It compares a new drug combination with standard care.
- The goal is to see if the new combination prevents cancer recurrence better.
- Participation involves receiving treatment and close monitoring.
- You can discuss any concerns with your healthcare team.
Who may be eligible?
To join this study, you would need to have triple-negative breast cancer that has been confirmed by special tests. You should also have had chemotherapy before your surgery (neoadjuvant treatment) and still had some cancer cells found after your operation. Importantly, there should be no signs that the cancer has spread to other parts of your body or come back where it was before.
Your surgery must have successfully removed all visible cancer in your breast and/or lymph nodes, and you should be recovering well from it. You must also be able to continue receiving pembrolizumab, which is part of the standard care after neoadjuvant treatment. There's a time limit for joining: you need to be enrolled within 16 weeks of your surgery. If you've had radiotherapy, you must have completed it and recovered before joining.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do I have triple-negative breast cancer that has been confirmed?
- Did I have chemotherapy before my breast cancer surgery?
- Was there still some cancer found after my surgery?
- Have I fully recovered from my surgery and any radiotherapy?
- Am I able to continue taking pembrolizumab (if applicable to my treatment plan)?
- Is it less than 16 weeks since my surgery?
What does participation involve?
If you decide to take part in this study, you will be assigned by chance (like flipping a coin) to receive either the new drug combination (sacituzumab tirumotecan plus pembrolizumab) or the doctor's choice of standard care, which could be pembrolizumab alone or with capecitabine. Neither you nor your doctor will get to choose which group you are in. You will have regular visits to the clinic for treatments, check-ups, blood tests, and scans to monitor how you are doing and to check for any side effects.
The treatments will be given over a period of time, and the doctors will explain the schedule for your specific treatment group. There will be ongoing follow-up appointments even after your main treatment period finishes, to keep a close eye on your health and check if the cancer returns. The total duration of your involvement, including follow-up, will be determined by the study design and your personal progress, and your study team will provide more specific details.
Potential risks and benefits
Locations (297)
- Infirmary Cancer Care ( Site 0001)Verified postcodeMobile, United States· Recruiting
- Ironwood Cancer & Research Centers-Research ( Site 0054)Verified postcodeChandler, United States· Recruiting
- MemorialCare Orange Coast Medical Center ( Site 9501)Verified postcodeFountain Valley, United States· Recruiting
- Scripps Cancer Center ( Site 0052)Verified postcodeLa Jolla, United States· Recruiting
- Cancer and Blood Specialty Clinic ( Site 0008)Verified postcodeLos Alamitos, United States· Completed
- Kaiser Permanente - Oakland ( Site 0079)Verified postcodeOakland, United States· Recruiting
- Profound Research LLC ( Site 0105)Verified postcodeOceanside, United States· Recruiting
- Kaiser Permanente - Roseville ( Site 0081)Verified postcodeRoseville, United States· Recruiting
- Kaiser Permanente - San Francisco ( Site 0080)Verified postcodeSan Francisco, United States· Recruiting
- Kaiser Permanente - Santa Clara ( Site 0082)Verified postcodeSanta Clara, United States· Recruiting
- Providence Medical Foundation ( Site 9543)Verified postcodeSanta Rosa, United States· Recruiting
- Kaiser Permanente Vallejo Medical Center ( Site 0060)Verified postcodeVallejo, United States· Recruiting
Common questions
What is 'triple-negative breast cancer'?
It's a type of breast cancer that doesn't have certain features (receptors for oestrogen, progesterone, or HER2 protein), making particular targeted treatments ineffective. This means doctors have to use other types of treatment.
What does 'neoadjuvant therapy' mean?
It means you had chemotherapy or other treatments before your surgery to help shrink the tumour.
What does 'non-pathologic complete response' mean?
It means that after your surgery, even though the main tumour was removed, some cancer cells were still found when doctors looked at the tissue under a microscope. This is what the study is designed for.
What are the drugs, pembrolizumab and sacituzumab tirumotecan?
Pembrolizumab is an immunotherapy that helps your own immune system fight cancer. Sacituzumab tirumotecan is a targeted chemotherapy drug that delivers a powerful medicine directly to cancer cells.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, which means both you and your doctors will know which treatment you are receiving.
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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