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 - EvoPAR-BR01

Study identifier:D9722C00001

ClinicalTrials.gov identifier:NCT06380751

EudraCT identifier:N/A

CTIS identifier:2023-504180-16-00

Recruiting

Official Title

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)

Medical condition

Advanced breast cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Saruparib (AZD5305), Camizestrant, Abemaciclib, Ribociclib, Palbociclib, Fulvestrant, Letrozole, Anastrozole, Exemestane

Sex

All

Estimated Enrollment

500

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 01 Aug 2024
Estimated Primary Completion Date: 30 Mar 2029
Estimated Study Completion Date: 18 Jul 2030

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria