Clinical Trial

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)

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:

• HR-positive (ER ≥ 1%), HER2-negative (IHC 0/1+ or IHC 2+/ ISH-) based
  on local testing
• LA/MBC with no prior systemic therapy in the advanced/metastatic
  setting
  • ET is allowed up to 28 days before C1D1
• Participants must have BRCA1/2 or PALB2 loss of function mutation prior
  to screening, either germline/tumor tissue (local testing)
  • FFPE tumor tissue must be provided for prospective central confirmation
• Pre/peri-menopausal women and males must be on an LHRH agonist
• At least 1 measurable and/or non-measurable lesion that can be accurately
  assessed at baseline and is suitable for repeated assessment as per
  RECIST v1.1
• 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