Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, 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
Start Date
8/1/2024
Completion Date
12/30/2031
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 4680 participants will be screened to achieve approximately 788 participants randomised to study intervention. Participants will be randomised in a 2:2:1:2 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 * Arm 4: Saruparib (AZD5305) plus physician's choice ET Treatment continues until BICR-confirmed disease progression, unacceptable toxicity occurs, or the participant withdraws consent.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Saruparib (AZD5305)
Camizestrant
Abemaciclib
Ribociclib
Palbociclib
Fulvestrant
Letrozole
Anastrozole
Exemestane
Conditions
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Gilbert, Arizona 85234
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Fountain Valley, California 92708
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Glendale, California 91206
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Los Angeles, California 90089
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Newport Beach, California 92663
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Aurora, Colorado 80045
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Grand Junction, Colorado 81501
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Hollywood, Florida 33021
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Jacksonville, Florida 32224
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Orlando, Florida 32806
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Arlington Heights, Illinois 60005
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Chicago, Illinois 60611
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Evanston, Illinois 60201
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Park Ridge, Illinois 60068
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Urbana, Illinois 61801
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Winfield, Illinois 60190
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Indianapolis, Indiana 46227
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Louisville, Kentucky 40207
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Baltimore, Maryland 21201
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Silver Spring, Maryland 20902
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Silver Spring, Maryland 20904
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Boston, Massachusetts 02215
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Dearborn, Michigan 48126
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Detroit, Michigan 48202
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Royal Oak, Michigan 48073
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Royal Oak, Michigan 48073
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Rochester, Minnesota 55905
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Saint Joseph, Missouri 64507
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Springfield, Missouri 65804
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St Louis, Missouri 63110
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Camden, New Jersey 08103
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New Brunswick, New Jersey 08901
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Brooklyn, New York 11220
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Mineola, New York 11501
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New Hyde Park, New York 11042
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New York, New York 10016
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New York, New York 10028
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New York, New York 10065
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Shirley, New York 11967
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Stony Brook, New York 11790
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The Bronx, New York 10469
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Westbury, New York 11590
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Hershey, Pennsylvania 17033
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Philadelphia, Pennsylvania 19104
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Pittsburgh, Pennsylvania 15212
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Pittsburgh, Pennsylvania 15215
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West Columbia, South Carolina 29169
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Chattanooga, Tennessee 37404
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Nashville, Tennessee 37203
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Houston, Texas 77030
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Houston, Texas 77030
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Houston, Texas 77054
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Norfolk, Virginia 23502
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Tacoma, Washington 98405
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Milwaukee, Wisconsin 53215
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Ciudad Autónoma Buenos Aires, 1125
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Ciudad de Buenos Aires, 1015
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Ciudad de Buenos Aires, C1280AEB
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Córdoba, 5008
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Rosario, S2000KZE
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Salta, A4400EMI
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San Miguel de Tucumán, 4000
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Darlinghurst, 2010
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Darlinghurst, 2139
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Malvern, 3144
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Melbourne, VIC 3000
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Graz, 8036
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Innsbruck, 6020
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Linz, 4010
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Cachoeira de Itapemirim, 29308-055
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Curitiba, 80060-900
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Fortaleza, 60336-045
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Goiânia, 74000-000
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Jaú, 17210-120
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Porto Alegre, 91350-200
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Ribeirão Preto, 14049-901
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Salvador, 41253-190
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São Paulo, 01509-900
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São Paulo, 03102-002
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Plovdiv, 4002
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Sofia, 1527
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Stara Zagora, 6003
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Vratsa, 3000
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Toronto, Ontario M5G 2M9
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Greenfield Park, Quebec J4V 2G9
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Montreal, Quebec H2X 0A9
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Montreal, Quebec H3T 1E2
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Saskatoon, Saskatchewan S7N 4H4
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Toronto, M4N 3M5
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Providencia, 7500994
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Recoleta, 8420391
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Santiago, 8330034
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Talca, 3461341
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Viña del Mar, 2520000
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Beijing, 100044
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Bengbu, 233004
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Changchun, 130012
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Changchun, 130021
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Changsha, 410008
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Changsha, 410013
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Chongqing, 400042
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Foshan, 528000
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Fuzhou, 350014
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Hangzhou, 310016
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