Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
GlaxoSmithKline
Study ID
NCT00320385
Phase
PHASE3
Status
Completed

Conditions

  • Neoplasms, Breast

Eligibility Criteria

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

Interventions

  • Lapatinib — DRUG
    oral lapatinib once daily
  • Trastuzumab — BIOLOGICAL
    IV trastuzumab 2mg/kg weekly after 4mg/kg loading dose

Study Details

This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer.

Key Dates

Start date
Nov 30, 2005
Status verified
Apr 2015
Primary completion
Jun 30, 2007
Completion
Oct 31, 2010

Study Design

Enrollment
296 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Lapatinib plus Trastuzumab
    Lapatinib 1000mg once daily in combination with trastuzumab 4mg/kg loading dose followed by 2mg/kg weekly
  • Experimental: Arm 2: Lapatinib
    Lapatinib 1500mg once daily

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Baseline to disease progression or death due to any cause or 30 days after last dose (up to 216 weeks) ]

Locations (87)

FacilityCityStateZIPSite coordinators
GSK Investigational SitePhoenixArizona85012-
GSK Investigational SiteSedonaArizona86336-
GSK Investigational SiteHighlandCalifornia92346-
GSK Investigational SiteSacramentoCalifornia95819-
GSK Investigational SiteSan DiegoCalifornia92120-
GSK Investigational SiteSan FranciscoCalifornia94115-1710-
GSK Investigational SiteSanta RosaCalifornia95403-1757-
GSK Investigational SiteVallejoCalifornia94589-
GSK Investigational SiteNewarkDelaware19713-
GSK Investigational SiteBoca RatonFlorida33428-
GSK Investigational SiteFort MyersFlorida33916-
GSK Investigational SiteGainesvilleFlorida32605-
GSK Investigational SiteHollywoodFlorida33021-
GSK Investigational SiteJacksonvilleFlorida32256-
GSK Investigational SiteMiamiFlorida33136-
GSK Investigational SiteOcalaFlorida34474-
GSK Investigational SiteOcoeeFlorida34761-
GSK Investigational SiteOrlandoFlorida32804-
GSK Investigational SiteWest Palm BeachFlorida33401-
GSK Investigational SiteLawrencevilleGeorgia30046-7650-
GSK Investigational SiteNilesIllinois60714-
GSK Investigational SiteIndianapolisIndiana46202-
GSK Investigational SiteIndianapolisIndiana46227-
GSK Investigational SiteTerre HauteIndiana47802-
GSK Investigational SiteCedar RapidsIowa52403-
GSK Investigational SiteKansas CityKansas66103-
GSK Investigational SiteOverland ParkKansas66210-
GSK Investigational SiteBostonMassachusetts02115-
GSK Investigational SiteMinneapolisMinnesota55404-
GSK Investigational SiteRobbinsdaleMinnesota55422-
GSK Investigational SiteColumbiaMissouri65201-
GSK Investigational SiteSaint JosephMissouri64507-
GSK Investigational SiteLas VegasNevada89109-
GSK Investigational SiteLas VegasNevada89135-
GSK Investigational SiteMontclairNew Jersey07042-
GSK Investigational SiteMorristownNew Jersey07962-
GSK Investigational SiteNew BrunswickNew Jersey08901-
GSK Investigational SiteSummitNew Jersey07901-
GSK Investigational SiteVoorhees TownshipNew Jersey08043-
GSK Investigational SiteAlbanyNew York12208-
GSK Investigational SiteNew YorkNew York10016-
GSK Investigational SiteCaryNorth Carolina27511-
GSK Investigational SiteCharlotteNorth Carolina28203-
GSK Investigational SiteDurhamNorth Carolina27710-
GSK Investigational SiteHickoryNorth Carolina28602-
GSK Investigational SiteCantonOhio44710-
GSK Investigational SiteKetteringOhio45409-
GSK Investigational SiteOklahoma CityOklahoma73112-
GSK Investigational SiteTulsaOklahoma74136-1902-
GSK Investigational SiteBryn MawrPennsylvania19010-
GSK Investigational SiteHersheyPennsylvania17033-
GSK Investigational SiteKingstonPennsylvania18704-
GSK Investigational SitePhiladelphiaPennsylvania19104-
GSK Investigational SitePittsburghPennsylvania15213-
GSK Investigational SiteWest ReadingPennsylvania19611-
GSK Investigational SiteGreenvilleSouth Carolina29605-
GSK Investigational SiteNashvilleTennessee37203-
GSK Investigational SiteArlingtonTexas76014-
GSK Investigational SiteAustinTexas78731-
GSK Investigational SiteBeaumontTexas77702-1449-
GSK Investigational SiteBedfordTexas76022-
GSK Investigational SiteDallasTexas75230-
GSK Investigational SiteDallasTexas75231-
GSK Investigational SiteDallasTexas75237-
GSK Investigational SiteDallasTexas75246-
GSK Investigational SiteDentonTexas76210-
GSK Investigational SiteEl PasoTexas79915-
GSK Investigational SiteFort WorthTexas76104-
GSK Investigational SiteFredericksburgTexas78624-
GSK Investigational SiteLewisvilleTexas75067-
GSK Investigational SiteLongviewTexas75601-
GSK Investigational SiteMcAllenTexas78503-1298-
GSK Investigational SiteMesquiteTexas75150-
GSK Investigational SiteMidlandTexas79701-
GSK Investigational SiteOdessaTexas79761-
GSK Investigational SiteParisTexas75460-
GSK Investigational SiteTylerTexas75702-
GSK Investigational SiteWacoTexas76712-
GSK Investigational SiteNorfolkVirginia23502-
GSK Investigational SiteRichmondVirginia23230-
GSK Investigational SiteSalemVirginia24153-
GSK Investigational SiteEdmondsWashington98026-
GSK Investigational SiteSeattleWashington98133-
GSK Investigational SiteSpokaneWashington99202-
GSK Investigational SiteVancouverWashington98684-
GSK Investigational SiteYakimaWashington98902-
GSK Investigational SiteGreen BayWisconsin54301-

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