Study identifier:D9722C00001
ClinicalTrials.gov identifier:NCT06380751
EudraCT identifier:N/A
CTIS identifier:2023-504180-16-00
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)
Advanced breast cancer
Phase 3
No
Saruparib (AZD5305), Camizestrant, Abemaciclib, Ribociclib, Palbociclib, Fulvestrant, Letrozole, Anastrozole, Exemestane
All
500
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1: saruparib (AZD5305) plus camizestrant participants will receive saruparib (AZD5305) orally and camizestrant orally | Drug: Saruparib (AZD5305) Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2. Drug: Camizestrant Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings . |
Active Comparator: Arm 2: Physician’s choice CDK4/6i plus physician’s choice ET agents are indicated below and should follow local guidelines: -Physician’s Choice CDK4/6i: o abemaciclib orally, or o ribociclib orally, or o palbociclib orally. -Physician's Choice ET: o fulvestrant intramuscularly, or o One of the following AIs: •letrozole orally, or •anastrozole orally, or •exemestane orally | Drug: Abemaciclib CDK4/6 Inhibitor Drug: Ribociclib CDK4/6 Inhibitor Drug: Palbociclib CDK 4/6 Inhibitor Drug: Fulvestrant Endocrine Therapy Drug: Letrozole Endorcine Therapy Drug: Anastrozole Endocrine Therapy Drug: Exemestane Endocrine Therapy |
Experimental: Arm 3: Physician’s choice CDK4/6i plus camizestrant participants will receive camizestrant orally. Agents for CDK4/6i treatment are indicated above and should follow local guidelines | Drug: Camizestrant Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings . Drug: Abemaciclib CDK4/6 Inhibitor Drug: Ribociclib CDK4/6 Inhibitor Drug: Palbociclib CDK 4/6 Inhibitor |