Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-23-125
Prinicipal Investigator
Vasekar, Monali
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
D9722C00001
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)
Objective
Primary Objective:
To demonstrate the superiority of saruparib (AZD5305) + camizestrant relative to physician s choice CDK4/6i + ET, by assessment of PFS.
Secondary Objectives:
To demonstrate the superiority of saruparib (AZD5305) + camizestrant relative to physician s choice CDK4/6i + ET by assessment of OS.
Applicable Disease Sites
Breast
Status
Open
Participating Institutions
Hershey Medical Center