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Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 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
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
Official 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2024-08-01
Completion Date
2030-10-18
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
Saruparib (AZD5305)
Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2.
Camizestrant
Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings .
Abemaciclib
CDK4/6 Inhibitor
Ribociclib
CDK4/6 Inhibitor
Palbociclib
CDK 4/6 Inhibitor
Fulvestrant
Endocrine Therapy
Letrozole
Endorcine Therapy
Anastrozole
Endocrine Therapy
Exemestane
Endocrine Therapy
Locations (296)
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Gilbert, Arizona, United States
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Fountain Valley, California, United States
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Glendale, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Aurora, Colorado, United States
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Grand Junction, Colorado, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Park Ridge, Illinois, United States
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Urbana, Illinois, United States
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Winfield, Illinois, United States
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Indianapolis, Indiana, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Silver Spring, Maryland, United States
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Boston, Massachusetts, United States
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Dearborn, Michigan, United States
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Royal Oak, Michigan, United States
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Royal Oak, Michigan, United States
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Rochester, Minnesota, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Camden, New Jersey, United States
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New Brunswick, New Jersey, United States
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Mineola, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Shirley, New York, United States
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Ciudad Autónoma Buenos Aires, Argentina
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Rosario, Argentina
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San Miguel de Tucumán, Argentina
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Graz, Austria
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Seoul, South Korea
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Seoul, South Korea
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Cáceres, Spain
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Granada, Spain
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L'Hospitalet de Llobregat, Spain
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Madrid, Spain
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Málaga, Spain
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Pamplona, Spain
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Seville, Spain
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Valencia, Spain
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Taichung, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
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Dusit, Thailand
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Muang, Thailand
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Ratchathewi, Thailand
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Ratchathewi, Thailand
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Adapazarı, Turkey (Türkiye)
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Altındağ-Ankara, Turkey (Türkiye)
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Çankaya, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Cambridge, United Kingdom
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Guildford, United Kingdom
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Truro, United Kingdom