EvoPAR-Breast01: Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative, BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
Condition: Breast Cancer
Sponsor: AstraZeneca
Full Title
Protocol D9722C00001: 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
Study Treatment
Study participant treatment will be randomized 2:2:1 between the following 3 treatment arms:
- Arm 1: PARP1 inhibitor saruparib in combination with next generation selective estrogen receptor degrader camizestrant
- Arm 2: Physician's choice CDK4/6 inhibitor in combination with standard endocrine therapy
- Arm 3: Physician's choice CDK4/6 inhibitor in combination with camizestrant
Eligibility/Info
Advanced or metastatic hormone receptor positive, HER2 negative breast cancer with a loss of function mutation in BRCA1, BRCA2, or PALB2. Participants must not have been treated with systemic anti-cancer therapy in the advanced/metastatic setting.
Contact
For more information you may contact the Research Department through the NYCBS HALO Messaging Center or call directly: 631-675-5075.
