Clinical Trial

Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant versus Physician’s Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)(D9722C00001)

MOA: Saruparib (AZD5305) is a selective inhibitor of PARP1, with minimal effect on PARP2. Camizestrant (AZD9833) is a next generation SERD with activity in both ESR1 mutant and WT settings.

Key Eligibility:

• Histologically or cytologically documented HR-positive (ER > 1%), HER2-negative (IHC 0/1+ or IHC 2+/ ISH-) based on local testing
• Locally advanced/metastatic breast cancer with no prior systemic therapy in the advanced/metastatic setting
• Participants must have BRCA1/2 or PALB2 loss of function mutation prior to screening, either germline (local testing) or somatic (central testing)
• Pre/peri-menopausal women and males must be on an LHRH agonist
• Measurable disease by RECIST 1.1
• Disease progression ≤84 days following (neo)adj tx for EBC excluded
• Disease progression ≤1 year from last dose of PARPi, platinum-agent, CDK4/6i, or oral SERD for EBC excluded