Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT00073528
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Lapatinib — DRUG
    1500 mg orally once a day
  • Letrozole — DRUG
    2.5 mg orally once a day
  • Placebo — DRUG
    Placebo (which matched with lapatinib tablet)

Study Details

This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or metastatic breast cancer, who had not received prior therapy for advanced or metastatic disease.

Key Dates

Start date
Dec 9, 2003
Status verified
Feb 2021
Primary completion
Jun 3, 2008
Completion
Mar 22, 2018

Study Design

Enrollment
1,286 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo + Letrozole 2.5 mg
    Letrozole (2.5 mg once daily orally) with Placebo (which matched with Lapatinib tablet)
  • Experimental: Lapatinib 1500 mg + Letrozole 2.5 mg
    Lapatinib (1500 mg once daily orally) with Letrozole (2.5 mg once daily orally)

Primary Outcome Measure

Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator [ Time Frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months ]

Locations (84)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteTucsonArizona85715-
Novartis Investigative SiteHot SpringsArkansas71913-
Novartis Investigative SiteJonesboroArkansas72401-
Novartis Investigative SiteAlhambraCalifornia91801-
Novartis Investigative SiteBakersfieldCalifornia93309-
Novartis Investigative SiteDuarteCalifornia91010-
Novartis Investigative SiteFountain ValleyCalifornia92708-
Novartis Investigative SiteFresnoCalifornia93710-
Novartis Investigative SiteFullertonCalifornia92835-
Novartis Investigative SiteLa JollaCalifornia92093-0987-
Novartis Investigative SiteLong BeachCalifornia90813-
Novartis Investigative SiteLos AngelesCalifornia90095-
Novartis Investigative SiteMontebelloCalifornia90640-
Novartis Investigative SiteNorthridgeCalifornia91325-
Novartis Investigative SiteOxnardCalifornia93030-
Novartis Investigative SitePleasant HillCalifornia94523-
Novartis Investigative SitePortervilleCalifornia93257-
Novartis Investigative SiteRedondo BeachCalifornia90277-
Novartis Investigative SiteSan DiegoCalifornia92120-
Novartis Investigative SiteSanta BarbaraCalifornia93105-
Novartis Investigative SiteSanta MariaCalifornia93454-
Novartis Investigative SiteVallejoCalifornia94589-
Novartis Investigative SiteVistaCalifornia92081-
Novartis Investigative SiteAuroraColorado80045-
Novartis Investigative SiteDenverColorado80220-
Novartis Investigative SiteLongmontColorado80501-
Novartis Investigative SiteWheat RidgeColorado80033-
Novartis Investigative SiteNew HavenConnecticut06520-
Novartis Investigative SiteBoca RatonFlorida33428-
Novartis Investigative SiteBoca RatonFlorida33486-
Novartis Investigative SiteGainesvilleFlorida32605-
Novartis Investigative SiteGainesvilleFlorida32610-
Novartis Investigative SiteHollywoodFlorida33021-
Novartis Investigative SiteLakelandFlorida33805-
Novartis Investigative SiteMiamiFlorida33136-
Novartis Investigative SiteOrlandoFlorida32804-
Novartis Investigative SitePort Saint LucieFlorida34952-
Novartis Investigative SiteWest Palm BeachFlorida33401-
Novartis Investigative SiteAtlantaGeorgia30341-
Novartis Investigative SiteMariettaGeorgia30060-
Novartis Investigative SiteSavannahGeorgia31406-
Novartis Investigative SitePeoriaIllinois61615-
Novartis Investigative SiteSkokieIllinois60076-
Novartis Investigative SiteIndianapolisIndiana46202-
Novartis Investigative SiteBettendorfIowa52722-
Novartis Investigative SiteLouisvilleKentucky40202-
Novartis Investigative SiteMetairieLouisiana70006-
Novartis Investigative SiteNew OrleansLouisiana70121-
Novartis Investigative SiteWorcesterMassachusetts01608-
Novartis Investigative SiteDuluthMinnesota55805-
Novartis Investigative SiteMinneapolisMinnesota55407-3799-
Novartis Investigative SiteRobbinsdaleMinnesota55422-
Novartis Investigative SiteSaint Louis ParkMinnesota55426-
Novartis Investigative SiteSaint CharlesMissouri63304-
Novartis Investigative SiteSt LouisMissouri63141-
Novartis Investigative SiteOmahaNebraska68114-
Novartis Investigative SiteLas VegasNevada89169-
Novartis Investigative SiteVoorhees TownshipNew Jersey08043-
Novartis Investigative SiteSanta FeNew Mexico87505-
Novartis Investigative SiteManhassetNew York11030-
Novartis Investigative SiteRochesterNew York14623-
Novartis Investigative SiteChapel HillNorth Carolina27599-7305-
Novartis Investigative SiteGreenvilleNorth Carolina27834-
Novartis Investigative SiteFargoNorth Dakota58103-
Novartis Investigative SiteCantonOhio44718-
Novartis Investigative SiteHersheyPennsylvania17033-
Novartis Investigative SitePhiladelphiaPennsylvania19111-
Novartis Investigative SitePittsburghPennsylvania15212-
Novartis Investigative SiteWest ColumbiaSouth Carolina29210-
Novartis Investigative SiteGermantownTennessee38138-
Novartis Investigative SiteKnoxvilleTennessee37916-
Novartis Investigative SiteAmarilloTexas79106-
Novartis Investigative SiteDallasTexas75246-
Novartis Investigative SiteDallasTexas75390-9113-
Novartis Investigative SiteHoustonTexas77025-
Novartis Investigative SiteIrvingTexas75061-
Novartis Investigative SiteOgdenUtah84403-
Novartis Investigative SiteSalt Lake CityUtah84106-
Novartis Investigative SiteBurlingtonVermont05401-
Novartis Investigative SiteDanvilleVirginia24541-
Novartis Investigative SiteRichmondVirginia23230-
Novartis Investigative SiteSeattleWashington98104-
Novartis Investigative SiteTacomaWashington98405-
Novartis Investigative SiteCharlestonWest Virginia25304-

Find similar trials in Tucson, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Novartis Investigative Site· Tucson, AZNovartis Investigative Site· Hot Springs, ARNovartis Investigative Site· Jonesboro, ARNovartis Investigative Site· Alhambra, CANovartis Investigative Site· Bakersfield, CANovartis Investigative Site· Duarte, CA

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