A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT05774951
Phase
PHASE3
Status
Recruiting
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Conditions

  • Breast Cancer, Early Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Camizestrant — DRUG
    Camizestrant. Experimental. Administered orally
  • Tamoxifen — DRUG
    Tamoxifen. Comparator. Administered per local approved label
  • Anastrozole — DRUG
    Anastrozole. Comparator. Administered per local approved label
  • Letrozole — DRUG
    Letrozole. Comparator. Administered per local approved label
  • Exemestane — DRUG
    Exemestane. Comparator. Administered per local approved label

Study Details

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

Key Dates

Start date
Mar 31, 2023
Status verified
May 2026
Primary completion
Apr 20, 2027
Completion
May 29, 2036

Study Design

Enrollment
4,300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: standard endocrine therapy of investigator´s choice
    Continue standard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen)
  • Experimental: Arm B: camizestrant
    Camizestrant

Primary Outcome Measure

Invasive breast cancer-free survival (IBCFS) [ Time Frame: Up to 10 years ]

Central Contacts

Locations (129)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35205-
Research SiteDothanAlabama36303-
Research SiteAnchorageAlaska99508-
Research SiteChandlerArizona85224-
Research SiteHot SpringsArkansas71913-
Research SiteAnaheimCalifornia92801-
Research SiteBeverly HillsCalifornia90211-
Research SiteConcordCalifornia94520-
Research SiteCoronaCalifornia92882-
Research SiteFountain ValleyCalifornia92708-
Research SiteGreenbraeCalifornia94904-
Research SiteLos AlamitosCalifornia90720-
Research SitePalo AltoCalifornia94304-
Research SiteSan DiegoCalifornia92121-
Research SiteSan DiegoCalifornia92123-
Research SiteWhittierCalifornia90603-
Research SiteAuroraColorado80045-
Research SiteHartfordConnecticut06102-
Research SiteFort MyersFlorida33901-
Research SiteGainesvilleFlorida32603-
Research SiteMiami BeachFlorida33140-
Research SiteOrlandoFlorida32806-
Research SitePlantationFlorida33324-
Research SitePort Saint LucieFlorida34952-
Research SiteSaint AugustineFlorida32086-
Research SiteSt. PetersburgFlorida33705-
Research SiteSt. PetersburgFlorida33709-
Research SiteTallahasseeFlorida32308-
Research SiteWest Palm BeachFlorida33401-
Research SiteWinter HavenFlorida33880-
Research SiteAtlantaGeorgia30310-
Research SiteAtlantaGeorgia30318-
Research SiteColumbusGeorgia31904-
Research SiteHonoluluHawaii96813-
Research SiteChicagoIllinois60608-
Research SiteChicagoIllinois60637-
Research SiteDecaturIllinois62526-
Research SiteElmhurstIllinois60126-
Research SiteHinsdaleIllinois60521-
Research SitePark RidgeIllinois60068-
Research SitePark RidgeIllinois60068-
Research SiteFort WayneIndiana46804-
Research SiteIowa CityIowa52242-
Research SiteIowa CityIowa52242-
Research SiteFort MitchellKentucky41017-
Research SiteLexingtonKentucky40536-
Research SiteLouisvilleKentucky40202-
Research SiteBaton RougeLouisiana70809-
Research SiteBrewerMaine04412-
Research SiteScarboroughMaine04074-
Research SiteFrederickMaryland21702-
Research SiteGlenn DaleMaryland20769-
Research SiteSilver SpringMaryland20910-
Research SiteTowsonMaryland21204-
Research SiteBostonMassachusetts02111-
Research SiteHyannisMassachusetts02601-
Research SiteAnn ArborMichigan48109-
Research SiteDetroitMichigan48202-
Research SiteEast LansingMichigan48824-
Research SiteLansingMichigan48910-
Research SiteRoyal OakMichigan48073-
Research SiteIndependenceMissouri64057-
Research SiteLincolnNebraska68506-
Research SiteLas VegasNevada89148-
Research SiteLaconiaNew Hampshire03246-
Research SiteBellevilleNew Jersey07109-
Research SiteFarmingtonNew Mexico87401-
Research SiteSanta FeNew Mexico87505-
Research SiteEast SyracuseNew York13057-
Research SiteNew Hyde ParkNew York11042-
Research SiteNew YorkNew York10011-
Research SiteNew YorkNew York10019-
Research SiteNew YorkNew York10029-
Research SiteStony BrookNew York11794-
Research SiteThe BronxNew York10461-
Research SiteWhite PlainsNew York10601-
Research SiteCharlotteNorth Carolina28204-
Research SiteDurhamNorth Carolina27710-0001-
Research SiteGreensboroNorth Carolina27403-
Research SiteRaleighNorth Carolina27607-
Research SiteRocky MountNorth Carolina27804-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteWinston-SalemNorth Carolina27104-
Research SiteCincinnatiOhio45219-
Research SiteCincinnatiOhio45255-
Research SiteClevelandOhio44106-
Research SiteClevelandOhio44195-
Research SiteYoungstownOhio44504-
Research SiteClairtonPennsylvania15025-
Research SitePhiladelphiaPennsylvania19106-
Research SitePhiladelphiaPennsylvania19111-
Research SitePittsburghPennsylvania15213-
Research SitePittsburghPennsylvania15213-
Research SiteReadingPennsylvania19611-
Research SiteState CollegePennsylvania16803-
Research SiteProvidenceRhode Island02903-
Research SiteLancasterSouth Carolina29720-
Research SiteSpartanburgSouth Carolina29303-
Research SiteAberdeenSouth Dakota57401-
Research SiteMitchellSouth Dakota57301-
Research SitePierreSouth Dakota57501-
Research SiteSioux FallsSouth Dakota57105-
Research SiteYanktonSouth Dakota57078-
Research SiteChattanoogaTennessee37404-
Research SiteKnoxvilleTennessee37920-
Research SiteNashvilleTennessee37203-
Research SiteNashvilleTennessee37204-
Research SiteAustinTexas78731-
Research SiteDallasTexas75230-
Research SiteDentonTexas76201-
Research SiteHoustonTexas77024-
Research SiteHoustonTexas77030-
Research SiteIrvingTexas75063-
Research SiteOgdenUtah84405-
Research SiteSalt Lake CityUtah84106-
Research SiteFairfaxVirginia22031-
Research SiteLynchburgVirginia24501-
Research SiteMidlothianVirginia23114-
Research SiteRestonVirginia20190-
Research SiteRichmondVirginia23235-
Research SiteSeattleWashington98101-
Research SiteSeattleWashington98104-
Research SiteSpokaneWashington99202-
Research SiteTacomaWashington98405-
Research SiteCharlestonWest Virginia25304-
Research SiteMorgantownWest Virginia26505-
Research SiteAppletonWisconsin54911-
Research SiteMadisonWisconsin53792-
Research SiteMilwaukeeWisconsin53226-

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