An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

Part of paid clinical trials in Dothan, Alabama.

Sponsor
AstraZeneca
Study ID
NCT05952557
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 orally
  • Anastrozole — DRUG
    Anastrozole. Comparator. Administered orally
  • Letrozole — DRUG
    Letrozole. Comparator. Administered orally
  • Exemestane — DRUG
    Exemestane. Comparator. Administered orally
  • Abemaciclib — DRUG
    Abemaciclib adjuvant treatment Administered orally

Study Details

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.

Key Dates

Start date
Oct 5, 2023
Status verified
May 2026
Primary completion
Mar 4, 2030
Completion
May 6, 2037

Study Design

Enrollment
5,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Invasive breast cancer-free survival (IBCFS) [ Time Frame: Up to 14 years ]

Central Contacts

Locations (148)

FacilityCityStateZIPSite coordinators
Research SiteDothanAlabama36303-
Research SitePhoenixArizona85054-
Research SiteTucsonArizona85745-
Research SiteFayettevilleArkansas72703-
Research SiteDuarteCalifornia91010-
Research SiteFountain ValleyCalifornia92708-
Research SiteGreenbraeCalifornia94904-
Research SiteIrvineCalifornia92618-
Research SiteLa JollaCalifornia92093-
Research SiteLos AngelesCalifornia90017-
Research SiteMontereyCalifornia93940-
Research SiteWalnut CreekCalifornia94598-
Research SiteWest HollywoodCalifornia90048-
Research SiteAuroraColorado80045-
Research SiteLittletonColorado80120-
Research SiteLittletonColorado80129-
Research SiteNew HavenConnecticut06510-
Research SiteNewarkDelaware19713-
Research SiteWashington D.C.District of Columbia20016-
Research SiteClearwaterFlorida33756-
Research SiteFort MyersFlorida33901-
Research SiteGainesvilleFlorida32610-
Research SiteJacksonvilleFlorida32224-
Research SiteOrlandoFlorida32806-
Research SitePembroke PinesFlorida33028-
Research SitePlantationFlorida33322-
Research SitePlantationFlorida33324-
Research SiteSt. PetersburgFlorida33705-
Research SiteSt. PetersburgFlorida33709-
Research SiteTallahasseeFlorida32308-
Research SiteWest Palm BeachFlorida33401-
Research SiteAtlantaGeorgia30318-
Research SiteAtlantaGeorgia30322-
Research SiteColumbusGeorgia31904-
Research SiteMariettaGeorgia30060-
Research SiteSavannahGeorgia31404-
Research SiteThomasvilleGeorgia31792-
Research SiteChicagoIllinois60637-
Research SiteElmhurstIllinois60126-
Research SiteNapervilleIllinois60540-
Research SitePark RidgeIllinois60068-
Research SitePlainfieldIllinois60585-
Research SiteUrbanaIllinois61801-
Research SiteFort WayneIndiana46804-
Research SiteDes MoinesIowa50309-
Research SiteFairwayKansas66205-
Research SiteLouisvilleKentucky40202-
Research SiteNew OrleansLouisiana70121-
Research SiteScarboroughMaine04074-
Research SiteAnnapolisMaryland21401-
Research SiteBaltimoreMaryland21201-
Research SiteBaltimoreMaryland21287-
Research SiteBethesdaMaryland20817-
Research SiteLuthervilleMaryland21093-
Research SiteTowsonMaryland21204-
Research SiteBostonMassachusetts02111-
Research SiteBostonMassachusetts02115-
Research SiteHyannisMassachusetts02601-
Research SiteWorcesterMassachusetts01655-
Research SiteDetroitMichigan48202-
Research SiteFlintMichigan48503-
Research SiteYpsilantiMichigan48197-
Research SiteMinneapolisMinnesota55416-
Research SiteRochesterMinnesota55905-
Research SiteKansas CityMissouri64111-
Research SiteSt LouisMissouri63110-
Research SiteSt LouisMissouri63131-
Research SiteLincolnNebraska68506-
Research SiteOmahaNebraska68124-
Research SiteOmahaNebraska68198-
Research SiteHooksettNew Hampshire03106-
Research SiteLebanonNew Hampshire03756-
Research SiteManchesterNew Hampshire03103-
Research SiteNew BrunswickNew Jersey08901-
Research SiteAlbuquerqueNew Mexico87109-
Research SiteFarmingtonNew Mexico87401-
Research SiteBay ShoreNew York11706-
Research SiteEast SyracuseNew York13057-
Research SiteGreenlawnNew York11740-
Research SiteNew Hyde ParkNew York11042-
Research SiteNew YorkNew York10029-
Research SiteNew YorkNew York10065-
Research SiteNew YorkNew York10065-
Research SiteStony BrookNew York11794-
Research SiteWhite PlainsNew York10601-
Research SiteCharlotteNorth Carolina28204-
Research SiteDurhamNorth Carolina27710-
Research SiteGreensboroNorth Carolina27403-
Research SiteGreenvilleNorth Carolina27834-
Research SitePinehurstNorth Carolina28374-
Research SiteRaleighNorth Carolina27607-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteBlue AshOhio45242-
Research SiteCincinnatiOhio45255-
Research SiteClevelandOhio44106-
Research SiteColumbusOhio43212-
Research SiteToledoOhio43623-
Research SiteYoungstownOhio44504-
Research SiteOklahoma CityOklahoma73104-
Research SitePortlandOregon97210-
Research SitePortlandOregon97213-
Research SitePortlandOregon97225-
Research SiteGettysburgPennsylvania17325-
Research SiteHersheyPennsylvania17033-
Research SitePhiladelphiaPennsylvania19104-
Research SitePittsburghPennsylvania15213-
Research SiteSayrePennsylvania18840-
Research SiteYorkPennsylvania17403-
Research SiteCharlestonSouth Carolina29425-
Research SiteGreenvilleSouth Carolina29605-
Research SiteRock HillSouth Carolina29732-
Research SiteSpartanburgSouth Carolina29303-
Research SiteAberdeenSouth Dakota57401-
Research SiteSioux FallsSouth Dakota57105-
Research SiteChattanoogaTennessee37404-
Research SiteKnoxvilleTennessee37909-
Research SiteKnoxvilleTennessee37920-
Research SiteMemphisTennessee38120-
Research SiteNashvilleTennessee37203-
Research SiteNashvilleTennessee37232-
Research SiteAustinTexas78731-
Research SiteBedfordTexas76022-
Research SiteDallasTexas75230-
Research SiteDallasTexas75231-
Research SiteDallasTexas75246-
Research SiteEl PasoTexas79902-
Research SiteFlower MoundTexas75028-
Research SiteHoustonTexas77024-
Research SiteHoustonTexas77030-
Research SitePlanoTexas75075-
Research SiteSan AntonioTexas78217-
Research SiteTylerTexas75702-
Research SiteSalt Lake CityUtah84112-
Research SiteCharlottesvilleVirginia22908-
Research SiteFairfaxVirginia22031-
Research SiteMidlothianVirginia23114-
Research SiteNorfolkVirginia23502-
Research SiteRichmondVirginia23219-
Research SiteRoanokeVirginia24014-
Research SiteWinchesterVirginia22601-
Research SitePuyallupWashington98373-
Research SiteSpokaneWashington99202-
Research SiteVancouverWashington98684-
Research SiteCharlestonWest Virginia25304-
Research SiteMorgantownWest Virginia26505-
Research SiteAppletonWisconsin54911-
Research SiteMadisonWisconsin53792-
Research SiteMilwaukeeWisconsin53215-

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