protocolSection identificationModule nctId: NCT06380751, orgStudyIdInfo id: D9722C00001, briefTitle: 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, acronym: EvoPAR-BR01, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2029-03-30, completionDateStruct date: 2030-07-18, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Advanced Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Open label, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Saruparib (AZD5305), interventions name: Camizestrant, interventions name: Abemaciclib, interventions name: Ribociclib, interventions name: Palbociclib, interventions name: Fulvestrant, interventions name: Letrozole, interventions name: Anastrozole, interventions name: Exemestane, outcomesModule primaryOutcomes measure: Progression-Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Progression Free Survival 2, secondaryOutcomes measure: Time to chemotherapy, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Participant-reported tolerability, secondaryOutcomes measure: Time to deterioration in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ), secondaryOutcomes measure: Change from baseline in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ), secondaryOutcomes measure: Plasma concentrations of saruparib (AZD5305), secondaryOutcomes measure: Plasma concentrations of camizestrant, secondaryOutcomes measure: Samples will be used to develop companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, city: Toronto, state: Ontario, zip: M5G 2M9, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Research Site, city: Montreal, state: Quebec, zip: H3T 1E2, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Research Site, city: Montréal, state: Quebec, zip: H2X 0A9, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Research Site, city: Saskatoon, state: Saskatchewan, zip: S7N 4H4, country: Canada, geoPoint lat: 52.13238, lon: -106.66892, locations facility: Research Site, city: Toronto, zip: M4N 3M5, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False