Comparing Saruparib Plus Camizestrant or Endocrine Therapy with CDK46 Inhibitor Plus Endocrine Therapy in Advanced Breast Cancer Patients with BRCA1, BRCA2, or PALB2 Mutations

What this Trial Is About

Researchers are studying advanced breast cancer patients who have mutations in BRCA1, BRCA2, or PALB2 genes and whose cancer is hormone receptor-positive and HER2-negative. The study aims to compare the effectiveness of saruparib AZD5305 combined with camizestrant against standard treatments involving CDK46 inhibitors plus endocrine therapy. This is a phase III clinical trial conducted to evaluate treatment options for this specific breast cancer group. Participants will be randomly assigned to one of four treatment groups saruparib plus camizestrant physicians choice of CDK46 inhibitor plus endocrine therapy physicians choice of CDK46 inhibitor plus camizestrant or saruparib plus physicians choice endocrine therapy. Treatments are given orally or by injection according to the group, and continue until the disease progresses, unacceptable side effects occur, or the participant chooses to stop. During the study, participants will undergo assessments to monitor disease progression and treatment effects, including scans and laboratory tests. Researchers will measure progression-free survival and other outcomes such as overall survival, response rates, and quality of life over several years. Safety and tolerability will also be closely observed throughout the study period, which may last up to about 88 months.

Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer