This clinical trial is focused on studying a type of breast cancer known as triple-negative breast cancer (TNBC). The study will explore the effectiveness and safety of a new treatment combination. The treatment involves a medication called MK-2870, which is a powder for solution for injection, used together with another medication called pembrolizumab, also known as Keytruda. Pembrolizumab is a concentrate for solution for infusion. The purpose of the study is to compare this combination treatment to other treatments chosen by doctors for patients who have undergone surgery for TNBC but did not achieve a complete response to their initial therapy.
Participants in the study will receive the treatment over a period of up to 24 months. The study will involve regular visits to the clinic for treatment administration and monitoring. The treatment will be given through an intravenous infusion, which means it will be delivered directly into the bloodstream through a vein. The study will also include the use of other medications such as capecitabine, dexamethasone, and paracetamol as needed, depending on the treatment plan chosen by the doctors. Some participants may receive a placebo instead of the active treatment to help compare the effects.
The main goal of the study is to assess how well the treatment works in preventing the return of cancer, known as invasive disease-free survival (iDFS). The study will also look at other important outcomes, such as overall survival and quality of life. Participants will be closely monitored for any side effects or adverse events during the study. The study aims to provide valuable information on the potential benefits of the new treatment combination for people with TNBC who have not fully responded to their initial therapy.
1joining the study
Upon joining the study, the participant is confirmed to have triple negative breast cancer (TNBC) and has undergone surgery without achieving a complete response.
The participant must have completed neoadjuvant therapy and surgery according to guidelines and be ready to start the trial within 12 weeks post-surgery.
2randomization
The participant is randomly assigned to receive either the combination of MK-2870 and pembrolizumab or the treatment of the physician’s choice, which may include pembrolizumab alone or with capecitabine.
3treatment administration
If assigned to the MK-2870 and pembrolizumab group, the participant receives MK-2870 as a powder for solution for injection and pembrolizumab as a solution for infusion.
If assigned to the treatment of physician’s choice, the participant may receive pembrolizumab as a solution for infusion, possibly combined with capecitabine taken orally.
4monitoring and assessments
Throughout the trial, the participant’s health and response to treatment are monitored regularly.
Assessments include checking for invasive disease-free survival and overall survival, as well as monitoring for any adverse events.
5completion of the trial
The trial is estimated to end by December 14, 2037, with the participant’s involvement concluding upon completion of the treatment and final assessments.
Who Can Join the Study?
Has been diagnosed with triple negative breast cancer (TNBC), confirmed by specific medical guidelines.
If capable of producing sperm, agrees to use effective birth control during the study and for a certain period after the last dose of the study medication. Also agrees not to donate sperm during this time.
For females, is not pregnant or breastfeeding. If of childbearing potential, uses effective birth control during the study and for a specified time after the last dose of the study medication. Agrees not to breastfeed during the study and for a certain period afterward.
Has recovered from any side effects of previous cancer treatments to a mild level or back to normal, except for hair loss.
If living with HIV, the condition is well controlled with medication.
Has a good general health status, as measured by a specific performance scale, within 7 days before starting the study treatment.
If positive for hepatitis B, has been on antiviral therapy for at least 4 weeks and has no detectable virus in the blood before starting the study.
Has no signs of cancer returning in the local area or spreading to other parts of the body, as checked by the doctor.
Has received a specific type of pre-surgery treatment for TNBC, followed by surgery, and completed at least 5 doses of a particular medication and chemotherapy.
Has had all visible cancer removed from the breast and/or lymph nodes through surgery and has recovered well from the surgery.
Did not have a complete response to treatment at the time of surgery.
Is able to continue receiving a specific medication after surgery.
Is randomized to the study within 12 weeks after surgery.
If needed, has completed radiation therapy after surgery and has recovered before starting the study.
Has provided a tissue sample from the surgery for specific laboratory testing.
Who Cannot Join the Study?
Patients who have a different type of breast cancer other than triple negative breast cancer cannot participate. Triple negative breast cancer is a type of breast cancer that does not have three common receptors known to fuel most breast cancer growth.
Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet other specific health criteria set by the study organizers cannot participate. These criteria are designed to ensure the safety and effectiveness of the study.
MK-2870 is an investigational medication being studied for its potential to help treat triple-negative breast cancer. It is being tested in combination with another medication to see if it can improve outcomes for patients who have not achieved a complete response to previous treatments.
Pembrolizumab is a medication used to help the immune system fight cancer cells. It is being used in this study to see if it can improve the effectiveness of treatment for patients with triple-negative breast cancer.
Capecitabine is a chemotherapy drug that is used to treat various types of cancer, including breast cancer. In this study, it is being combined with pembrolizumab to see if the combination can provide better results for patients who have not fully responded to earlier treatments.
Triple Negative Breast Cancer – This is a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. It is considered more aggressive and difficult to treat than other types of breast cancer. The cancer cells in triple negative breast cancer do not respond to hormonal therapy medicines or medicines that target HER2 protein receptors. It tends to grow and spread more quickly than other types of breast cancer. This type of cancer is more likely to affect younger women and those with a BRCA1 gene mutation. It is often diagnosed at a higher grade and stage, which can influence the approach to treatment.
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