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NCT06380751 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study of Advanced Breast Cancer, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT06380751: Recruiting Phase 3 study of Advanced Breast Cancer, sponsored by AstraZeneca.
NCT06380751 is a Phase 3 study of Advanced Breast Cancer that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 500 participants, above the 447-participant average among 28 other Advanced Breast Cancer trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06380751, a Phase 3 study of Advanced Breast Cancer, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by BICR, or death due to any cause.
Conditions Studied
Interventions
- DRUG Saruparib (AZD5305)
- DRUG Camizestrant
- DRUG Palbociclib
- DRUG Abemaciclib
- DRUG Ribociclib
Study Locations (20)
Illinois
- Research Site - Chicago
- Research Site - Evanston
- Research Site - Park Ridge
- Research Site - Urbana
- Research Site - Winfield
California
- Research Site - Fountain Valley
- Research Site - Glendale
- Research Site - Los Angeles
- Research Site - Newport Beach
Florida
- Research Site - Hollywood
- Research Site - Jacksonville
- Research Site - Orlando
Maryland
- Research Site - Baltimore
- Research Site - Silver Spring
- Research Site - Silver Spring
Colorado
- Research Site - Aurora
- Research Site - Grand Junction
Arizona
- Research Site - Gilbert
Indiana
- Research Site - Indianapolis
Kentucky
- Research Site - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2030-10-18 |
| Phase | Phase 3 |
What NCT06380751 shows while recruiting
NCT06380751 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 447-participant average among 28 other Advanced Breast Cancer trials with a reported enrollment target (12% higher).
The record links to 1 condition, with Advanced Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Saruparib (AZD5305) is the first listed.
NCT06380751 names 20 study sites across 8 states, led by Illinois, California, Florida.
Frequently Asked Questions
What is clinical trial NCT06380751 about?
NCT06380751 is a clinical study titled "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". 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
What is the current status of trial NCT06380751?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2024-08-01. Estimated completion is 2030-10-18.
What conditions does trial NCT06380751 study?
This clinical trial studies the following conditions: Advanced Breast Cancer.
What interventions are being tested in trial NCT06380751?
The interventions under investigation include: Saruparib (AZD5305) (DRUG), Camizestrant (DRUG), Palbociclib (DRUG), Abemaciclib (DRUG), Ribociclib (DRUG).
Who is sponsoring clinical trial NCT06380751?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06380751 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06380751's enrollment target sits among peer trials
500 6th of 28 higher than 22 of 28 other Advanced Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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