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NCT06380751 · ClinicalTrials.gov record · last posted 2026-07-30

Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, 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

Study acronym: EvoPAR-BR01
StatusRecruiting
PhasePhase 3
Started2024-08-01
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from the ClinicalTrials.gov record
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

Protocol amendment history 6 changes detected by DataLookout

2026-07-31
Primary endpoint(s) modified
WasProgression-Free Survival
NowProgression-Free Survival (Arm 1 vs arm 2)
2026-07-31
Enrollment increased: 500 → 788 participants
2026-07-31
Trial arms changed: 3 → 4
2026-07-31
Primary completion pushed: 2029-03-30 → 2029-12-18
2026-07-31
Completion pushed: 2030-10-18 → 2031-12-30
2026-06-30
Trial sites expanded: 298 → 301 locations
Trial Details
NCT Number NCT06380751
Lead Sponsor AstraZeneca
Conditions Advanced Breast Cancer
Enrollment 788 participants
Start Date 2024-08-01
Primary Completion 2029-12-18 (estimated)
Study Completion 2031-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-30