drugset / Trial / 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

NCT06380751

Phase 3 Recruiting 500 enrolled AstraZeneca
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2024-08-01
Primary completion
2029-03-30
Completion
2030-10-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Abemaciclib Small molecule Oral
Comparator Anastrozole Other / unclassified Oral
Subject Camizestrant Other / unclassified Oral
Comparator Exemestane Small molecule Oral
Comparator Fulvestrant Small molecule Intramuscular
Comparator Letrozole Other / unclassified Oral
Subject Palbociclib Small molecule Oral
Subject Ribociclib Small molecule Oral
Subject Saruparib Small molecule Oral