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)
Status: Recruiting
Location: See all (275) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult females, pre/peri-menopausal and/or post-menopausal, and adult males
• Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer
• Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease
• ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks
• FFPE tumour tissue from each participant
• Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2
• Adequate organ and marrow function
Locations
United States
Arizona
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Gilbert
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Glendale
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Los Angeles
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Newport Beach
Colorado
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Aurora
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Grand Junction
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Hollywood
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Jacksonville
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Orlando
Illinois
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Chicago
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Evanston
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Park Ridge
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Winfield
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Indianapolis
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Boston
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Silver Spring
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Silver Spring
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Detroit
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Camden
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Mineola
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New Hyde Park
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New York
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New York
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Shirley
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The Bronx
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Westbury
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Hershey
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Philadelphia
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Graz
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Linz
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Montreal
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Recoleta
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Guangzhou
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Guangzhou
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Hangzhou
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Hangzhou
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Harbin
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Jining
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Liuzhou
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Luoyang
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Yokohama
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Lima
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Poznan
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Portugal
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Lisbon
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Puerto Rico
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Seoul
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Taoyuan District
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Ratchathewi
Turkey
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Istanbul
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United Kingdom
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Oxford
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Swansea
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Taunton
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Truro
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2030-10-18
Participants
Target number of participants: 500
Treatments
Experimental: Arm 1: saruparib (AZD5305) plus camizestrant
participants will receive saruparib (AZD5305) orally and camizestrant orally
Active_comparator: Arm 2: Physician's choice CDK4/6i plus physician's choice ET
agents are indicated below and should follow local guidelines:~* Physician's Choice CDK4/6i:~ * abemaciclib orally, or~ * ribociclib orally, or~ * palbociclib orally.~* Physician's Choice ET:~ * fulvestrant intramuscularly, or~ * One of the following AIs:~ * letrozole orally, or~ * anastrozole orally, or~ * exemestane orally
Experimental: Arm 3: Physician's choice CDK4/6i plus camizestrant
participants will receive camizestrant orally. Agents for CDK4/6i treatment are indicated above and should follow local guidelines
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca