NCT06380751

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Approximately 2,620 participants will be screened to achieve approximately 500 participants randomised to study intervention. Participants will be randomised in a 2:2:1 ratio to one of the following intervention groups: * Arm 1: saruparib (AZD5305) plus camizestrant * Arm 2: Physician's choice CDK4/6i plus physician's choice ET * Arm 3: Physician's choice CDK4/6i plus camizestrant Treatment continues until BICR-confirmed disease progression, unacceptable toxicity occurs, or the participant withdraws consent.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
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 .
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

Timeline

• Start date: 2024-08-01
• Primary completion: 2029-03-30
• Completion: 2030-10-18
• First posted: 2024-04-24
• Last updated: 2026-04-14

Locations

298 sites across 29 countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Czechia, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Peru, Poland, Portugal, Puerto Rico, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study