EvoPAR - Breast 01
Research type
Research Study
Full 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).
IRAS ID
1009751
Contact name
Adesola Obunge
Contact email
Sponsor organisation
AstraZeneca UK Ltd
Eudract number
2023-504180-16
Clinicaltrials.gov Identifier
Research summary
The primary objective of this study is to demonstrate the superiority of saruparib + camizestrant relative to physician’s choice CDK4/6i + ET, by assessment of PFS.
The purpose of this study is to learn more about whether saruparib combined with another study drug called camizestrant, works better for participants with advanced breast cancer when compared to current standard of care treatment: a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor combined with hormone therapy.
Saruparib is a type of drug known as a PARP1 inhibitor (polyadenosine di-phosphate ribose polymerase inhibitor). Approximately 500 participants will take part in this study at multiple different locations around the world.
Participants will receive treatment with saruparib plus camizestrant or physician’s choice CDK4/6i plus ET or physician’s choice CDK4/6i plus camizestrant, until BICR-confirmed disease progression by RECIST v1.1 or unacceptable toxicity occurs, or the participant withdraws consent.
Participants will be allocated to one of three different treatment regimens in this study:
• Arm 1: Saruparib with camizestrant
• Arm 2: Physician's choice CDK4/6 inhibitor with hormone therapy
• Arm 3: Physician's choice CDK4/6 inhibitor with camizestrant.Patients will take the study drug once a day during each cycle (28 days long) and they will be required to go to the study site every 2 weeks for the first 12 weeks after they start study treatment, and then every 4 weeks until they stop taking both study drugs.
Participants will have the following visits:
Bio-marker testing
Screening Visit
Cycle 1, Day 1
Cycle 1, Day 15
Cycle 2, Day 1
Cycle 2, Day 15
Cycle 3, Day 1
Cycle 3, Day 15
Cycles 4+, Day 1 of every cycle
Treatment Discontinuation
Disease Progression
Safety FU & Survival FU
Tumour imaging/ measurement (RECIST v1.1) from randomisation until RECIST v1.1-defined radiographic progression (by BICR).REC name
East Midlands - Derby Research Ethics Committee
REC reference
24/EM/0211
Date of REC Opinion
30 Aug 2024
REC opinion
Further Information Favourable Opinion