Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT06380751
Brief 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
Detailed Description:
Approximately 2,620 participants will be screened to achieve approximately 500 participants randomised to study intervention.
Participants will be randomised in a 2:2:1 ratio to one of the following intervention groups:
* Arm 1: saruparib (AZD5305) plus camizestrant
* Arm 2: Physician's choice CDK4/6i plus physician's choice ET
* Arm 3: Physician's choice CDK4/6i plus camizestrant Treatment continues until BICR-confirmed disease progression, unacceptable toxicity occurs, or the participant withdraws consent.
Study:
NCT06380751
Study Brief:
Protocol Section:
NCT06380751