Study of sacituzumab tirumotecan, pembrolizumab and chemotherapy combination for early-stage triple-negative breast cancer or hormone receptor-low positive/HER2-negative breast cancer
This clinical trial studies the treatment of triple-negative breast cancer and hormone receptor-low positive/HER2-negative breast cancer in its early stages. The study evaluates a new treatment approach using sacituzumab tirumotecan (also known as MK-2870) followed by carboplatin and paclitaxel, compared to standard chemotherapy. Both treatment options will be combined with pembrolizumab (Keytruda), a medication that helps the immune system fight cancer cells.
The treatment plan involves giving medications before surgery (neoadjuvant therapy) to shrink the tumor. The study medications are given through an intravenous infusion directly into the bloodstream. Some participants will receive the new combination with sacituzumab tirumotecan, while others will receive standard chemotherapy which may include doxorubicin, epirubicin, or cyclophosphamide. All participants will also receive dexamethasone to help manage side effects, and some may receive capecitabine as part of their treatment.
The main purpose of this research is to determine whether the new treatment combination is more effective at eliminating cancer cells before surgery compared to standard chemotherapy. The study will also track how long participants remain free of cancer after treatment and monitor their overall survival. Researchers will carefully watch for any side effects and evaluate how the treatments affect participants’ quality of life.
1Initial treatment assignment
You will be randomly assigned to one of two treatment groups for breast cancer therapy
Both groups will receive pembrolizumab (given through intravenous infusion)
2aTreatment Group A
If assigned to Group A, you will receive:
First phase: sacituzumab tirumotecan (MK-2870) through intravenous infusion
Second phase: Combination of carboplatin and paclitaxel through intravenous infusion
2bTreatment Group B
If assigned to Group B, you will receive standard chemotherapy which may include:
Doxorubicin through intravenous infusion
Epirubicin through intravenous infusion
Cyclophosphamide through intravenous infusion
Capecitabine taken by mouth
Dexamethasone taken by mouth
3Surgery evaluation
After completing the treatment phase, you will undergo surgery
The medical team will evaluate how well the treatment worked by examining the breast tissue removed during surgery
4Follow-up assessments
Regular check-ups to monitor your health status
Completion of quality of life questionnaires about your physical functioning and treatment side effects
Monitoring for any side effects or adverse events
5Study duration
The study is planned to run from July 2025 to December 2034
Your individual participation duration will be determined by your treatment plan and follow-up schedule
Who Can Join the Study?
You must have early-stage breast cancer that has not spread to other parts of the body (non-metastatic) and has not been treated before. The cancer must be either:
A tumor size larger than 2 cm but less than 5 cm with or without lymph node involvement, or
A tumor smaller than 2 cm with lymph node involvement
Your breast cancer must be confirmed by central testing as either:
Triple-negative breast cancer (cancer that does not have receptors for estrogen, progesterone, and HER2), or
Hormone receptor-low positive/HER2 negative breast cancer (cancer with low levels of hormone receptors and no HER2)
You must have good physical function, rated as ECOG 0 or 1 (able to perform daily activities with minimal assistance) within 28 days before starting treatment
Your heart function test must show a left ventricle ejection fraction (measurement of heart pumping ability) of 50% or higher
If you have previous exposure to anthracycline medications (a type of chemotherapy), your total lifetime doses must not exceed:
Doxorubicin: less than 100 mg/m²
Epirubicin: less than 180 mg/m²
Mitoxantrone: less than 40 mg/m²
Idarubicin: less than 22.5 mg/m²
Who Cannot Join the Study?
Previous cancer treatment with pembrolizumab (a type of immunotherapy drug) or similar medications
Active, untreated brain metastases (cancer that has spread to the brain)
Severe autoimmune disease (when your immune system attacks your own body)
History of pneumonitis (lung inflammation) requiring steroid treatment
Active infection requiring systemic treatment (medication that affects your whole body)
Uncontrolled high blood pressure
Unstable heart disease
History of organ transplant
Known HIV infection
Active hepatitis B or C infection
Pregnant or breastfeeding women
Unable to take oral medications
Any condition that would make participation unsafe
Participation in another clinical trial within the last 30 days
Sacituzumab Tirumotecan is a medication that combines an antibody that targets breast cancer cells with a drug that helps kill these cells. It’s specifically designed to treat triple-negative breast cancer and certain types of hormone receptor-low breast cancers.
Carboplatin is a chemotherapy medication that works by interfering with cancer cell DNA, helping to stop cancer cells from growing and dividing.
Paclitaxel is a chemotherapy drug that works by stopping cancer cells from dividing and growing. It’s commonly used in the treatment of various types of cancer, including breast cancer.
Pembrolizumab is an immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein that prevents your immune system from attacking cancer cells, allowing your body’s natural defenses to work better against the cancer.
Triple-negative breast cancer (TNBC) – A type of breast cancer where the cancer cells lack receptors for estrogen, progesterone, and HER2 protein. This cancer develops in the breast tissue and can grow quickly. The disease begins when breast cells start to multiply uncontrollably, forming a tumor. TNBC accounts for about 10-15% of all breast cancers.
Hormone receptor-low positive breast cancer – A form of breast cancer characterized by cells that have a low expression of hormone receptors (estrogen or progesterone) and are HER2 negative. This cancer develops when breast cells with low levels of hormone receptors begin to multiply abnormally. The disease represents a distinct subtype of breast cancer with unique biological characteristics.
Ductal carcinoma in situ (DCIS) – A non-invasive breast cancer that starts in the milk ducts of the breast. In this condition, abnormal cells are contained within the ducts and haven’t spread to surrounding breast tissue. DCIS is considered an early form of breast cancer. The abnormal cells look similar to invasive cancer cells when viewed under a microscope.
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