This clinical trial is focused on studying treatments for Advanced Breast Cancer, specifically in patients with certain genetic mutations known as BRCA1, BRCA2, or PALB2. The trial will explore the effectiveness and safety of a combination of two medications: Saruparib (also known by its code name AZD5305) and Camizestrant. These medications will be compared to the current standard treatment options, which include a type of medication called CDK4/6 inhibitors combined with Endocrine Therapy or Camizestrant alone. The study aims to determine if the new combination of Saruparib and Camizestrant is more effective in delaying the progression of the disease.
Participants in the study will receive either the new combination treatment or one of the standard treatments, which will be chosen by their doctor. The study will monitor how long the cancer remains stable without getting worse, as well as the overall survival of the participants. The trial will also assess the time it takes for participants to start chemotherapy after the study treatment, the response of the cancer to the treatment, and the duration of any positive response. Additionally, the study will gather information on the side effects experienced by participants, focusing on symptoms like diarrhea and abdominal pain, and how these affect their quality of life.
The trial will also measure the levels of Saruparib and Camizestrant in the blood to better understand how these drugs work in the body. The study is expected to start recruiting participants in late 2024 and will continue until 2030. This research is important for developing new treatment options for people with Advanced Breast Cancer who have specific genetic mutations, and it aims to improve the outcomes and quality of life for these patients.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of advanced breast cancer with certain genetic mutations.
Participants must have adequate organ and marrow function and meet other health requirements.
2randomization
Participants are randomly assigned to receive either the combination of saruparib and camizestrant or a physician’s choice of CDK4/6 inhibitor plus endocrine therapy or camizestrant.
3treatment administration
The treatment involves taking medications orally or via intramuscular injection, depending on the assigned group.
Medications include saruparib, camizestrant, and other options such as exemestane, palbociclib, abemaciclib, fulvestrant, anastrozole, letrozole, and ribociclib.
4monitoring and assessments
Regular monitoring is conducted to assess the progression of the disease and the effectiveness of the treatment.
Assessments include measuring progression-free survival and overall survival, as well as monitoring for any side effects.
5completion of treatment
The treatment continues until disease progression or unacceptable side effects occur.
The study aims to determine the time to chemotherapy and the duration of response to the treatment.
6follow-up
After completing the treatment, follow-up visits are scheduled to monitor long-term outcomes and any late side effects.
The study is estimated to conclude by July 18, 2030.
Who Can Join the Study?
Participants must be adult females, either before, during, or after menopause, and adult males.
Participants must have a confirmed diagnosis of breast cancer that is positive for hormone receptors (HR-positive) and negative for a protein called HER2.
Participants must have advanced breast cancer, which means the cancer has spread locally and cannot be cured with treatment, or it has spread to other parts of the body (metastatic).
Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
Participants must provide a sample of their tissue that shows a specific type of genetic change called a loss of function mutation in the BRCA1, BRCA2, or PALB2 genes.
Participants must have organs and bone marrow that are working well enough to participate in the study.
Who Cannot Join the Study?
Patients who have a different type of cancer other than Advanced Breast Cancer cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are not female or male subjects as required by the study cannot participate.
Patients who are considered part of a vulnerable population, which means they might need special protection or care, cannot participate.
Saruparib (AZD5305) is an experimental medication being studied for its potential to treat advanced breast cancer. It is being tested in combination with other therapies to see if it can help slow down or stop the progression of cancer in patients with specific genetic mutations.
Camizestrant is a medication used in the treatment of hormone receptor-positive breast cancer. It works by blocking the effects of estrogen, a hormone that can promote the growth of breast cancer cells. In this trial, it is being used in combination with other treatments to evaluate its effectiveness in managing advanced breast cancer.
CDK4/6 Inhibitors are a class of drugs used in cancer treatment that work by interfering with the cancer cell cycle, effectively slowing down or stopping the growth of cancer cells. In this study, they are being used as part of the physician’s choice treatment to compare their effectiveness with other therapies in treating advanced breast cancer.
Advanced Breast Cancer – This is a stage of breast cancer where the disease has spread beyond the initial site to other parts of the body. It often involves the lymph nodes, bones, liver, lungs, or brain. The progression of advanced breast cancer can vary, with some individuals experiencing rapid spread while others may have a slower progression. Symptoms may include persistent pain, fatigue, and changes in breast appearance or size. The disease can lead to complications depending on the organs affected. Management focuses on controlling the spread and alleviating symptoms.
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