This clinical trial is focused on studying treatments for hormone receptor-positive breast cancer that cannot be surgically removed. The study will compare the effectiveness of a new treatment called MK-2870, used alone or in combination with another medication called pembrolizumab, against standard chemotherapy treatments chosen by doctors. The goal is to see how well these treatments work in slowing down the progression of the cancer.
Participants in the study will receive either MK-2870 alone, MK-2870 with pembrolizumab, or a chemotherapy treatment selected by their physician. The study will last for a period of up to 12 months, during which the effects of the treatments will be monitored. The study aims to determine which treatment option is more effective in managing the cancer and improving the quality of life for participants.
The trial will involve regular check-ups and assessments to track the progress of the disease and any side effects experienced by participants. The study will help researchers understand the potential benefits and risks of using MK-2870 and pembrolizumab in treating this type of breast cancer, providing valuable information for future treatment options.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including having hormone receptor positive breast cancer that cannot be surgically removed.
Participants must have experienced disease progression on previous endocrine therapy and be candidates for chemotherapy.
2randomization
Participants are randomly assigned to one of the treatment groups. This could involve receiving the investigational drug MK-2870 alone, MK-2870 combined with pembrolizumab, or a treatment chosen by the physician.
3treatment administration
The investigational drug MK-2870 is administered as a powder for solution for injection.
If assigned to the combination group, pembrolizumab is given as an intravenous infusion.
The frequency and dosage of these medications are determined by the study protocol and the physician’s discretion.
4monitoring and assessments
Regular monitoring is conducted to assess the progression of the disease and the participant’s response to treatment.
Assessments include imaging studies and evaluations of overall health and quality of life using specific questionnaires.
5follow-up
Participants continue to be monitored for any changes in their condition and for any side effects from the treatment.
The study aims to measure progression-free survival and overall survival among other outcomes.
Who Can Join the Study?
The patient must have hormone receptor positive breast cancer that is either locally advanced (spread in the nearby area) or metastatic (spread to other parts of the body) and cannot be removed by surgery.
The patient must have shown disease progression (worsening of the cancer) on one or more treatments with endocrine therapy (hormone therapy) for their advanced or metastatic breast cancer. One of these treatments must have been combined with a CDK4/6 inhibitor (a type of drug that helps stop cancer cells from growing).
The patient must be a candidate for chemotherapy (a type of cancer treatment using drugs to kill cancer cells).
The patient must have an ECOG performance status of 0 to 1, which means they are fully active or have some symptoms but can carry out light work. This status must be assessed within 7 days before joining the study.
The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.
If the patient is infected with HIV (human immunodeficiency virus), their infection must be well controlled with antiretroviral therapy (medication that helps manage HIV).
If the patient has Hepatitis B and is positive for the Hepatitis B surface antigen (HBsAg), they must have been on HBV antiviral therapy for at least 4 weeks and have an undetectable HBV viral load (amount of virus in the blood).
If the patient has a history of Hepatitis C infection, their HCV viral load must be undetectable.
Who Cannot Join the Study?
Patients who have a different type of cancer that is not hormone receptor positive breast cancer.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are part of a vulnerable population, which means they might need special protection or care.
MK-2870 is an investigational medication being studied for its effectiveness in treating certain types of breast cancer. It is being tested both as a single treatment and in combination with another medication to see how well it works in slowing down or stopping the growth of cancer cells.
Pembrolizumab is a medication that helps the immune system fight cancer. It is used in combination with MK-2870 in this study to determine if the combination is more effective than other treatments chosen by doctors for patients with specific types of breast cancer.
Hormone Receptor Positive Breast Cancer – This type of breast cancer is characterized by the presence of receptors for hormones like estrogen or progesterone on the surface of the cancer cells. These receptors allow the cancer cells to grow in response to these hormones. The disease typically progresses as the cancer cells continue to multiply and spread, potentially affecting nearby tissues and organs. It is often detected through changes in breast tissue, such as lumps or changes in shape. The progression can vary, with some cases remaining localized while others may spread to other parts of the body. Understanding the hormone receptor status is crucial for determining the course of the disease.
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