Saruparib (AZD5305) Plus Camizestrant 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

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

Trial Details

NCT ID
NCT06380751
Phase
PHASE3
Sponsor
AstraZeneca
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Saruparib (AZD5305)
  • Camizestrant
  • Abemaciclib
  • Ribociclib
  • Palbociclib
  • Fulvestrant
Locations (sample)
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Fountain Valley, California, United States|33.70918,-117.95367
  • Glendale, California, United States|34.14251,-118.25508
  • Los Angeles, California, United States|34.05223,-118.24368
  • Newport Beach, California, United States|33.61891,-117.92895

Key Eligibility 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
  • ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks

For full eligibility, visit ClinicalTrials.gov.

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