A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant compared with Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients with BRCA1, BRCA2 or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+/ISH non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)
The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer
Why this Research Matters
Approximately 2,620 participants will be screened to achieve approximately 500 participants randomised to study intervention. Participants will be randomised in a 2:2:1 ratio to one of the following intervention groups: Arm 1: saruparib (AZD5305) plus camizestrant Arm 2: Physician's choice CDK4/6i plus physician's choice ET Arm 3: Physician's choice CDK4/6i plus camizestrant Treatment continues until BICR-confirmed disease progression, unacceptable toxicity occurs, or the participant withdraws consent.
Who can Participate
Inclusion Criteria: Adult females, pre/peri-menopausal and/or post-menopausal, and adult males Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2 Detailed eligibility criteria is available on ClinicalTrials.gov. These requirements will be discussed with your doctor and/or study representative. ClinicalTrials.gov to learn more about this study.
Study ID
Protocol Number: 24-1711
More information available at ClinicalTrials.gov: NCT06380751
Meet the Team
Principal Investigator