Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380751
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-03-25
Brief Title:
Saruparib AZD5305 Plus Camizestrant Compared With CDK46 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
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Randomised Open-Label Phase III Study of Saruparib AZD5305 Plus Camizestrant Compared With Physicians Choice CDK46 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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EvoPAR-BR01
Brief Summary:
The primary objective of the study is to measure efficacy of saruparib AZD5305 plus camizestrant compared with physicians choice CDK46i 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 2620 participants will be screened to achieve approximately 500 participants randomised to study intervention
Participants will be randomised in a 221 ratio to one of the following intervention groups
Arm 1 saruparib AZD5305 plus camizestrant
Arm 2 Physicians choice CDK46i plus physicians choice ET
Arm 3 Physicians choice CDK46i plus camizestrant Treatment continues until BICR-confirmed disease progression unacceptable toxicity occurs or the participant withdraws consent
Participants will be randomised in a 221 ratio to one of the following intervention groups
Arm 1 saruparib AZD5305 plus camizestrant
Arm 2 Physicians choice CDK46i plus physicians choice ET
Arm 3 Physicians choice CDK46i plus camizestrant Treatment continues until BICR-confirmed disease progression unacceptable toxicity occurs or the participant withdraws consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None