Evaluating sacituzumab tirumotecan alone or with pembrolizumab compared to standard treatment in untreated patients with metastatic triple-negative breast cancer with low PD-L1 expression
This study focuses on triple-negative breast cancer that has spread to other parts of the body or cannot be surgically removed. The study tests a new drug called sacituzumab tirumotecan (also known as MK-2870), both alone and in combination with another drug called pembrolizumab (KEYTRUDA). These treatments will be compared to standard treatment options which include paclitaxel, albumin-bound paclitaxel, or a combination of gemcitabine and carboplatin.
The purpose of this research is to determine how well sacituzumab tirumotecan works, both by itself and when combined with pembrolizumab, compared to standard treatments. The study will look at how these treatments affect cancer growth and patient survival. All medications will be given through intravenous infusion, which means they are delivered directly into the bloodstream through a vein.
During the study, patients will be randomly assigned to receive either sacituzumab tirumotecan alone, sacituzumab tirumotecan with pembrolizumab, or one of the standard treatment options. The study will monitor how the cancer responds to treatment and track any side effects that may occur. Patients will also complete questionnaires about their quality of life during treatment.
1Initial treatment assignment
You will be randomly assigned to one of three treatment groups:
– Group 1: sacituzumab tirumotecan alone
– Group 2: sacituzumab tirumotecan combined with pembrolizumab
– Group 3: physician’s choice treatment (either paclitaxel, albumin-bound paclitaxel, or gemcitabine with carboplatin)
2Treatment administration
All medications will be given through an intravenous infusion (directly into your vein)
Treatment will continue until either:
– Your disease shows signs of progression
– You experience unacceptable side effects
– Your doctor decides to stop the treatment
Regular visits to the clinic will be required for treatment administration
3Monitoring and assessments
Your health status will be regularly monitored through:
– Physical examinations
– Imaging tests to check how your disease responds to treatment
You will complete quality of life questionnaires about:
– Your overall health status
– Physical functioning
– Emotional well-being
– Fatigue levels
– Digestive symptoms
4Side effect monitoring
Any side effects will be carefully tracked and documented
Your doctor will monitor and manage any side effects that may occur
You may stop treatment if serious side effects develop
5Study duration
The study is planned to run from March 2025 to February 2030
Your individual participation length will depend on how your body responds to the treatment
Who Can Join the Study?
Must have triple-negative breast cancer (TNBC) that has spread locally and cannot be surgically removed, or has spread to other parts of the body, and cannot be cured
Must not have received any previous treatments for advanced or spreading TNBC
If previously treated for early-stage breast cancer, all treatments must have been completed at least 6 months before the cancer came back
Must be suitable to receive pembrolizumab (an immunotherapy drug) and one of these chemotherapy options:
paclitaxel
nab-paclitaxel
gemcitabine with carboplatin
Must have recovered from side effects of previous cancer treatments to mild level or baseline condition, except for hair loss or skin pigment changes
If living with HIV, the infection must be well-controlled with antiviral medications
If positive for hepatitis B, must have been receiving antiviral treatment for at least 4 weeks with undetectable virus levels
If having a history of hepatitis C, virus levels must be undetectable
Who Cannot Join the Study?
Patients who have PD-L1 expression (a protein marker) below CPS score of 10 in their tumor tissue
Patients under 18 years of age
Patients who have previously received treatment with pembrolizumab (an immunotherapy medication)
Patients with active brain metastases (cancer that has spread to the brain) that are not stable
Patients with active autoimmune disease requiring systemic treatment
Patients who have received live vaccines within 30 days before starting the study treatment
Patients with active infections requiring systemic therapy
Patients who are pregnant or breastfeeding
Patients with known history of severe allergic reactions to study medications
Patients who have received other investigational drugs within 4 weeks before starting this study
Patients with inadequate organ function (including liver, kidney, or bone marrow problems)
Patients with uncontrolled high blood pressure or heart disease
Sacituzumab Tirumotecan (sac-TMT) is a medication designed to target and treat breast cancer cells. It works by delivering an anti-cancer drug directly to cancer cells, helping to destroy them while limiting damage to healthy cells.
Pembrolizumab is an immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein called PD-L1, which can prevent your immune system from attacking cancer cells effectively.
Treatment of Physician’s Choice (TPC) refers to standard treatment options that your doctor may select based on your specific situation. This typically includes established cancer treatments that are currently available and approved for treating triple-negative breast cancer.
Triple-negative breast cancer (TNBC) – A type of breast cancer where cancer cells lack three common receptors: estrogen, progesterone, and HER2 protein. This cancer typically develops in breast tissue and can spread to nearby tissues and other parts of the body. TNBC tends to grow and spread more quickly than other types of breast cancer. The term “locally recurrent” means the cancer has returned to the same area after previous treatment, while “metastatic” indicates the cancer has spread to other parts of the body. This type of cancer is characterized by the presence of PD-L1 proteins on tumor cells, which can be measured using a scoring system called CPS (Combined Positive Score).
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