Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Part of paid clinical trials in Anchorage, Alabama.

Sponsor
AstraZeneca
Study ID
NCT02032823
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Olaparib — DRUG
    Patients will be administred olaparib orally twice daily (b.i.d.) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 ml of water
  • Placebo — DRUG
    Patients will be administred matching placebo. Two (2) tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 ml of water

Study Details

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Key Dates

Start date
Apr 22, 2014
Status verified
Apr 2026
Primary completion
Mar 27, 2020
Completion
May 28, 2029

Study Design

Enrollment
1,837 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib
    Olaparib tablets 300mg b.i.d. p.o.
  • Placebo Comparator: Placebo
    Placebo tablets b.i.d. p.o.

Primary Outcome Measure

Invasive Disease Free Survival (IDFS) [ Time Frame: From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months) ]

Locations (368)

FacilityCityStateZIPSite coordinators
Research SiteAnchorageAlabama99508-
Research SiteAnchorageAlaska99508-
Research SiteGilbertArizona85234-
Research SiteFort SmithArkansas--
Research SiteBaldwin ParkCalifornia--
Research SiteBerkeleyCalifornia94704-
Research SiteDuarteCalifornia91010-
Research SiteFontanaCalifornia92335-
Research SiteFresnoCalifornia--
Research SiteGreenbraeCalifornia94904-
Research SiteLos AngelesCalifornia70360-
Research SiteLos AngelesCalifornia90027-
Research SiteLos AngelesCalifornia90033-
Research SiteLos AngelesCalifornia--
Research SiteMartinezCalifornia--
Research SiteNewport BeachCalifornia92663-
Research SiteOaklandCalifornia94611-
Research SitePalo AltoCalifornia--
Research SiteParadiseCalifornia--
Research SiteRosevilleCalifornia95661-
Research SiteRosevilleCalifornia--
Research SiteSacramentoCalifornia95816-5680-
Research SiteSan FranciscoCalifornia94115-
Research SiteSan JoseCalifornia--
Research SiteSan LeandroCalifornia94577-
Research SiteSan MarcosCalifornia92078-
Research SiteSanta CruzCalifornia--
Research SiteSanta RosaCalifornia95403-
Research SiteSouth San FranciscoCalifornia--
Research SiteStocktonCalifornia--
Research SiteSunnyvaleCalifornia94086-
Research SiteSunnyvaleCalifornia--
Research SiteVacavilleCalifornia95688-
Research SiteVallejoCalifornia94589-
Research SiteWoodland HillsCalifornia--
Research SiteAuroraColorado80045-
Research SiteColorado SpringsColorado80907-
Research SiteDenverColorado80205-
Research SiteEdwardsColorado--
Research SiteFort CollinsColorado--
Research SiteLafayetteColorado80026-
Research SiteLone TreeColorado80124-
Research SiteDerbyConnecticut--
Research SiteFairfieldConnecticut--
Research SiteGuilfordConnecticut--
Research SiteNew HavenConnecticut--
Research SiteNorth HavenConnecticut--
Research SiteOrangeConnecticut--
Research SiteTorringtonConnecticut--
Research SiteTrumbullConnecticut--
Research SiteWaterburyConnecticut--
Research SiteNewarkDelaware19713-
Research SiteNewarkDelaware--
Research SiteWashington D.C.District of Columbia--
Research SiteDaytona BeachFlorida32114-
Research SiteDeerfield BeachFlorida--
Research SiteGainesvilleFlorida--
Research SiteMiamiFlorida33136-
Research SiteOrlandoFlorida32806-
Research SitePlantationFlorida33324-
Research SiteAtlantaGeorgia30322-
Research SiteColumbusGeorgia31904-
Research SiteDecaturGeorgia--
Research SiteMaconGeorgia--
Research SiteSavannahGeorgia31405-
Research SiteValdostaGeorgia31602-
Research Site‘AieaHawaii--
Research SiteHonoluluHawaii--
Research SiteKuakiniHawaii--
Research SiteBoiseIdaho--
Research SiteCoeur d'AleneIdaho83814-
Research SiteFruitlandIdaho--
Research SiteMeridianIdaho--
Research SiteNampaIdaho--
Research SitePost FallsIdaho83854-
Research SiteTwin FallsIdaho--
Research SiteCentraliaIllinois--
Research SiteChicagoIllinois60608-
Research SiteChicagoIllinois60611-
Research SiteChicagoIllinois60625-
Research SiteChicagoIllinois--
Research SiteDecaturIllinois--
Research SiteEffinghamIllinois--
Research SiteElmhurstIllinois60126-
Research SiteEvanstonIllinois--
Research SiteGlenviewIllinois--
Research SiteHighland ParkIllinois--
Research SiteJolietIllinois60435-
Research SiteMaywoodIllinois--
Research SiteMount VernonIllinois--
Research SitePeoriaIllinois--
Research SiteRockfordIllinois61114-
Research SiteWarrenvilleIllinois--
Research SiteElkhartIndiana--
Research SiteFort WayneIndiana46845-
Research SiteFort WayneIndiana--
Research SiteIndianapolisIndiana46202-
Research SiteIndianapolisIndiana--
Research SiteMishawakaIndiana--
Research SiteMuncieIndiana--
Research SiteMunsterIndiana46321-
Research SiteMunsterIndiana--
Research SitePlymouthIndiana--
Research SiteSouth BendIndiana--
Research SiteWestvilleIndiana--
Research SiteAmesIowa50010-
Research SiteAmesIowa--
Research SiteBettendorfIowa52722-
Research SiteCedar RapidsIowa52403-
Research SiteDavenportIowa52803-
Research SiteDavenportIowa52807-
Research SiteIowa CityIowa52242-
Research SiteIowa CityIowa--
Research SiteMason CityIowa50401-
Research SiteMason CityIowa--
Research SiteChanuteKansas--
Research SiteEl DoradoKansas--
Research SiteFairwayKansas66205-
Research SiteGarden CityKansas--
Research SiteHaysKansas--
Research SiteKansas CityKansas66112-
Research SiteKansas CityKansas--
Research SiteLawrenceKansas--
Research SiteNewtonKansas--
Research SiteOlatheKansas--
Research SiteSalinaKansas--
Research SiteTopekaKansas--
Research SiteWichitaKansas--
Research SiteWinfieldKansas--
Research SiteLexingtonKentucky40509-
Research SiteLouisvilleKentucky--
Research SiteBaton RougeLouisiana70809-
Research SiteBaton RougeLouisiana--
Research SiteCovingtonLouisiana--
Research SiteHoumaLouisiana--
Research SiteKennerLouisiana70065-
Research SiteMonroeLouisiana71202-
Research SiteNew OrleansLouisiana--
Research SiteShreveportLouisiana71103-
Research SiteShreveportLouisiana71105-
Research SiteSlidellLouisiana70458-
Research SiteAugustaMaine04330-
Research SiteBangorMaine--
Research SiteBelfastMaine4915-
Research SiteBiddefordMaine04005-
Research SitePortlandMaine--
Research SiteRockportMaine--
Research SiteSanfordMaine04073-
Research SiteScarboroughMaine04074-
Research SiteBaltimoreMaryland21202-
Research SiteBaltimoreMaryland21287-
Research SiteBaltimoreMaryland--
Research SiteBethesdaMaryland20814-
Research SiteEastonMaryland--
Research SiteFrederickMaryland21701-
Research SiteFrederickMaryland21702-
Research SiteFrederickMaryland--
Research SiteBostonMassachusetts--
Research SitePittsfieldMassachusetts--
Research SiteSpringfieldMassachusetts--
Research SiteAnn ArborMichigan--
Research SiteDetroitMichigan--
Research SiteFlintMichigan--
Research SiteGrand RapidsMichigan--
Research SiteJacksonMichigan--
Research SiteKalamazooMichigan--
Research SiteMuskegonMichigan--
Research SitePontiacMichigan48341-
Research SitePort HuronMichigan48060-
Research SiteRoyal OakMichigan48073-
Research SiteRoyal OakMichigan--
Research SiteSaint JosephMichigan--
Research SiteSouthfieldMichigan--
Research SiteTraverse CityMichigan--
Research SiteTroyMichigan--
Research SiteWarrenMichigan--
Research SiteBemidjiMinnesota56601-
Research SiteBurnsvilleMinnesota--
Research SiteDuluthMinnesota--
Research SiteEdinaMinnesota--
Research SiteFridleyMinnesota--
Research SiteMankatoMinnesota56001-
Research SiteMaple GroveMinnesota55369-
Research SiteMaplewoodMinnesota--
Research SiteMinneapolisMinnesota--
Research SiteRochesterMinnesota--
Research SiteSaint CloudMinnesota56303-
Research SiteSaint Louis ParkMinnesota--
Research SiteSaint PaulMinnesota--
Research SiteShakopeeMinnesota55379-
Research SiteWaconiaMinnesota--
Research SiteWoodburyMinnesota--
Research SiteJacksonMississippi--
Research SiteCape GirardeauMissouri--
Research SiteJoplinMissouri--
Research SiteKansas CityMissouri--
Research SiteLee's SummitMissouri--
Research SiteSpringfieldMissouri65807-
Research SiteSpringfieldMissouri--
Research SiteSt LouisMissouri63109-
Research SiteSt LouisMissouri63141-
Research SiteSt LouisMissouri--
Research SiteBozemanMontana59715-
Research SiteKalispellMontana59901-
Research SiteGrand IslandNebraska68803-
Research SiteLincolnNebraska68506-
Research SiteLincolnNebraska68510-
Research SiteNorfolkNebraska68701-
Research SiteOmahaNebraska68114-
Research SiteOmahaNebraska68124-
Research SiteOmahaNebraska--
Research SiteLebanonNew Hampshire03756-
Research SiteManchesterNew Hampshire03102-
Research SiteNashuaNew Hampshire03063-
Research SiteFlemingtonNew Jersey08822-
Research SiteHamiltonNew Jersey--
Research SiteMorristownNew Jersey07960-
Research SiteMount HollyNew Jersey--
Research SiteNew BrunswickNew Jersey--
Research SiteVoorhees TownshipNew Jersey--
Research SiteAlbuquerqueNew Mexico87102-
Research SiteAlbuquerqueNew Mexico--
Research SiteBrooklynNew York11215-
Research SiteCharlotteNew York--
Research SiteEast SyracuseNew York--
Research SiteNew Hyde ParkNew York11042-
Research SiteNew YorkNew York--
Research SiteRochesterNew York14642-
Research SiteThe BronxNew York--
Research SiteWhite PlainsNew York10601-
Research SiteAlbemarleNorth Carolina28002-
Research SiteAshevilleNorth Carolina--
Research SiteCharlotteNorth Carolina--
Research SiteClintonNorth Carolina--
Research SiteConcordNorth Carolina--
Research SiteDurhamNorth Carolina--
Research SiteGastoniaNorth Carolina--
Research SiteGoldsboroNorth Carolina--
Research SiteGreensboroNorth Carolina--
Research SiteHendersonvilleNorth Carolina28791-
Research SiteHendersonvilleNorth Carolina--
Research SiteJacksonvilleNorth Carolina--
Research SiteKinstonNorth Carolina--
Research SitePinehurstNorth Carolina--
Research SiteWilsonNorth Carolina--
Research SiteWinston-SalemNorth Carolina--
Research SiteFargoNorth Dakota58102-
Research SiteGrand ForksNorth Dakota58201-
Research SiteMinotNorth Dakota--
Research SiteAkronOhio--
Research SiteBeachwoodOhio44122-
Research SiteCantonOhio44710-
Research SiteClevelandOhio44106-
Research SiteClevelandOhio44130-
Research SiteClevelandOhio44195-
Research SiteColumbusOhio43215-
Research SiteColumbusOhio--
Research SiteDaytonOhio45429-
Research SiteDaytonOhio--
Research SiteElyriaOhio44035-
Research SiteEnglewoodOhio45415-
Research SiteFindlayOhio45840-
Research SiteMaumeeOhio--
Research SiteOregonOhio--
Research SiteParmaOhio44129-
Research SitePerrysburgOhio43551-
Research SiteSpringfieldOhio45504-
Research SiteSylvaniaOhio--
Research SiteToledoOhio--
Research SiteZanesvilleOhio43701-
Research SiteOklahoma CityOklahoma--
Research SiteTulsaOklahoma--
Research SitePortlandOregon--
Research SiteAbingtonPennsylvania--
Research SiteBroomallPennsylvania19008-
Research SiteBryn MawrPennsylvania--
Research SiteClairtonPennsylvania15025-
Research SiteDanvillePennsylvania--
Research SiteDrexel HillPennsylvania--
Research SiteEphrataPennsylvania17522-
Research SiteGettysburgPennsylvania17325-
Research SiteHarrisburgPennsylvania--
Research SiteHazletonPennsylvania--
Research SiteHersheyPennsylvania--
Research SiteLebanonPennsylvania17042-
Research SiteLewisburgPennsylvania17837-
Research SiteMediaPennsylvania--
Research SitePaoliPennsylvania19301-
Research SitePaoliPennsylvania--
Research SitePhiladelphiaPennsylvania--
Research SitePhoenixvillePennsylvania--
Research SitePittsburghPennsylvania--
Research SiteReadingPennsylvania19605-
Research SiteState CollegePennsylvania--
Research SiteWest ReadingPennsylvania19611-
Research SiteWest ReadingPennsylvania--
Research SiteWilkes-BarrePennsylvania--
Research SiteWilliamsportPennsylvania17701-
Research SiteWilliamsportPennsylvania--
Research SiteWynnewoodPennsylvania19096-
Research SiteYorkPennsylvania--
Research SiteAndersonSouth Carolina--
Research SiteCharlestonSouth Carolina--
Research SiteGreenvilleSouth Carolina--
Research SiteGreenwoodSouth Carolina--
Research SiteGreerSouth Carolina--
Research SiteSenecaSouth Carolina--
Research SiteSpartanburgSouth Carolina--
Research SiteSioux FallsSouth Dakota57105-
Research SiteHoustonTexas77030-
Research SiteLubbockTexas79415-
Research SiteLubbockTexas79430-
Research SiteLubbockTexas--
Research SiteRound RockTexas78665-
Research SiteTempleTexas--
Research SiteAmerican ForkUtah--
Research SiteMurrayUtah--
Research SiteOgdenUtah84403-
Research SiteProvoUtah--
Research SiteSt. GeorgeUtah--
Research SiteBerlin CornersVermont--
Research SiteBurlingtonVermont--
Research SiteAnnandaleVirginia22003-
Research SiteFairfaxVirginia--
Research SiteFredericksburgVirginia--
Research SiteLynchburgVirginia--
Research SiteMechanicsvilleVirginia23116-
Research SiteMidlothianVirginia--
Research SiteRichmondVirginia--
Research SiteSouth HillVirginia--
Research SiteCentraliaWashington98531-
Research SiteKennewickWashington99336-
Research SiteKirklandWashington98034-
Research SitePoulsboWashington98370-
Research SiteSeattleWashington98109-
Research SiteSeattleWashington--
Research SiteCharlestonWest Virginia--
Research SiteHuntingtonWest Virginia25701-
Research SiteMorgantownWest Virginia26506-
Research SiteParkersburgWest Virginia26101-
Research SiteBurlingtonWisconsin--
Research SiteChippewa FallsWisconsin54729-
Research SiteEau ClaireWisconsin54701-
Research SiteElkhornWisconsin--
Research SiteFond du LacWisconsin54937-
Research SiteGraftonWisconsin--
Research SiteGreen BayWisconsin54303-
Research SiteGreen BayWisconsin54311-6519-
Research SiteGreen BayWisconsin--
Research SiteKenoshaWisconsin--
Research SiteLa CrosseWisconsin54601-
Research SiteLadysmithWisconsin54848-
Research SiteMarinetteWisconsin54143-
Research SiteMarshfieldWisconsin54449-
Research SiteMenomonee FallsWisconsin--
Research SiteMilwaukeeWisconsin--
Research SiteMinocquaWisconsin54548-
Research SiteMukwonagoWisconsin--
Research SiteOconomowocWisconsin--
Research SiteRice LakeWisconsin54868-
Research SiteStevens PointWisconsin54482-
Research SiteSummitWisconsin--
Research SiteWaukeshaWisconsin--
Research SiteWausauWisconsin54401-
Research SiteWauwatosaWisconsin--
Research SiteWest AllisWisconsin--
Research SiteWestonWisconsin54476-
Research SiteWisconsin RapidsWisconsin54494-

Find similar trials in Anchorage, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Research Site· Anchorage, ALResearch Site· Anchorage, AKResearch Site· Gilbert, AZResearch Site· Fort Smith, ARResearch Site· Baldwin Park, CAResearch Site· Berkeley, CA

Related Studies