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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
AstraZeneca
Study ID
NCT06380751
Phase
PHASE3
Status
Recruiting
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Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Saruparib (AZD5305) — DRUG
    Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2.
  • Camizestrant — DRUG
    Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings .
  • Abemaciclib — DRUG
    CDK4/6 Inhibitor
  • Ribociclib — DRUG
    CDK4/6 Inhibitor
  • Palbociclib — DRUG
    CDK 4/6 Inhibitor
  • Fulvestrant — DRUG
    Endocrine Therapy
  • Letrozole — DRUG
    Endorcine Therapy
  • Anastrozole — DRUG
    Endocrine Therapy
  • Exemestane — DRUG
    Endocrine Therapy

Study Details

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

Key Dates

Start date
Aug 1, 2024
Status verified
May 2026
Primary completion
Mar 30, 2029
Completion
Oct 18, 2030

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Progression-Free Survival [ Time Frame: Up to approximately 59 months ]

Central Contacts

Locations (54)

FacilityCityStateZIPSite coordinators
Research SiteGilbertArizona85234-
Research SiteFountain ValleyCalifornia92708-
Research SiteGlendaleCalifornia91206-
Research SiteLos AngelesCalifornia90089-
Research SiteNewport BeachCalifornia92663-
Research SiteAuroraColorado80045-
Research SiteGrand JunctionColorado81501-
Research SiteHollywoodFlorida33021-
Research SiteJacksonvilleFlorida32224-
Research SiteOrlandoFlorida32806-
Research SiteChicagoIllinois60611-
Research SiteEvanstonIllinois60201-
Research SitePark RidgeIllinois60068-
Research SiteUrbanaIllinois61801-
Research SiteWinfieldIllinois60190-
Research SiteIndianapolisIndiana46227-
Research SiteLouisvilleKentucky40207-
Research SiteBaltimoreMaryland21201-
Research SiteSilver SpringMaryland20902-
Research SiteSilver SpringMaryland20904-
Research SiteBostonMassachusetts02215-
Research SiteDearbornMichigan48126-
Research SiteDetroitMichigan48202-
Research SiteRoyal OakMichigan48073-
Research SiteRoyal OakMichigan48073-
Research SiteRochesterMinnesota55905-
Research SiteSpringfieldMissouri65804-
Research SiteSt LouisMissouri63110-
Research SiteCamdenNew Jersey08103-
Research SiteNew BrunswickNew Jersey08901-
Research SiteBrooklynNew York11220-
Research SiteMineolaNew York11501-
Research SiteNew Hyde ParkNew York11042-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10028-
Research SiteNew YorkNew York10065-
Research SiteShirleyNew York11967-
Research SiteStony BrookNew York11790-
Research SiteThe BronxNew York10469-
Research SiteWestburyNew York11590-
Research SiteHersheyPennsylvania17033-
Research SitePhiladelphiaPennsylvania19104-
Research SitePittsburghPennsylvania15215-
Research SiteWest ColumbiaSouth Carolina29169-
Research SiteChattanoogaTennessee37404-
Research SiteNashvilleTennessee37203-
Research SiteHoustonTexas77030-
Research SiteHoustonTexas77030-
Research SiteHoustonTexas77054-
Research SiteSan AntonioTexas78240-
Research SiteNorfolkVirginia23502-
Research SiteTacomaWashington98405-
Research SiteMorgantownWest Virginia26506-
Research SiteMilwaukeeWisconsin53215-

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