Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT00667251
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • trastuzumab — BIOLOGICAL
    IV q weekly (loading dose 4mg/kg; subsequent doses 2mg/kg) or IV q 3 weekly (loading dose 8mg/kg, subsequent doses 6mg/kg).
  • docetaxel — DRUG
    75mg/m2 IV q 3 weekly, day 1 of a 3 week cycle for 8 cycles plus G-CSF (when given together with lapatinib).
  • lapatinib ditosylate — DRUG
    1250 mg once daily (while given with taxane). 1500mg once daily (when given alone after taxane completion).
  • paclitaxel — DRUG
    80mg/m2 IV q weekly days 1, 8 and 15 of a 4-week cycle for 6 cycles.

Study Details

This was a multi-center, multinational, randomized, open-label, Phase III study comparing combination taxane-based chemotherapy plus lapatinib to combination taxane-based chemotherapy plus trastuzumab in women with documented evidence of human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) (by local or central laboratory testing) who had received no prior chemotherapy or HER2 targeted therapy in the metastatic setting.

Key Dates

Start date
Oct 7, 2008
Status verified
Mar 2025
Primary completion
Aug 1, 2012
Completion
Jul 27, 2022

Study Design

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

Arms

  • Active Comparator: Lapatinib
    Plus taxane based chemotherapy
  • Active Comparator: Trastuzumab
    Plus taxane based chemotherapy.

Primary Outcome Measure

Progression Free Survival (PFS) at the Time of Primary Results [ Time Frame: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months ]

Locations (53)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteAnchorageAlaska99508-
Novartis Investigative SiteTucsonArizona85715-
Novartis Investigative SiteHot SpringsArkansas71913-
Novartis Investigative SiteBerkeleyCalifornia94704-
Novartis Investigative SiteHighlandCalifornia92346-
Novartis Investigative SiteMontebelloCalifornia90640-
Novartis Investigative SiteColorado SpringsColorado80907-
Novartis Investigative SiteDenverColorado80204-
Novartis Investigative SiteGreenwichConnecticut06830-
Novartis Investigative SiteSouthingtonConnecticut06489-
Novartis Investigative SiteStamfordConnecticut06902-3628-
Novartis Investigative SiteTrumbullConnecticut06611-
Novartis Investigative SiteWaterburyConnecticut06708-
Novartis Investigative SiteKissimmeeFlorida34741-
Novartis Investigative SiteLoxahatchee GrovesFlorida33470-
Novartis Investigative SiteNew Port RicheyFlorida34655-
Novartis Investigative SiteAugustaGeorgia30901-
Novartis Investigative SiteLawrencevilleGeorgia30046-
Novartis Investigative SiteSavannahGeorgia31405-
Novartis Investigative SitePost FallsIdaho83854-
Novartis Investigative SiteChicagoIllinois60657-
Novartis Investigative SiteOak LawnIllinois60453-
Novartis Investigative SiteEvansvilleIndiana47713-
Novartis Investigative SiteGoshenIndiana46526-
Novartis Investigative SiteIndianapolisIndiana46237-
Novartis Investigative SiteMunsterIndiana46321-
Novartis Investigative SiteNew AlbanyIndiana47150-
Novartis Investigative SiteTowsonMaryland21204-
Novartis Investigative SiteWheatonMaryland20902-
Novartis Investigative SiteBozemanMontana59715-
Novartis Investigative SiteGrand IslandNebraska68803-
Novartis Investigative SiteKearneyNebraska68845-
Novartis Investigative SiteKearneyNebraska68847-
Novartis Investigative SiteDenvilleNew Jersey07834-
Novartis Investigative SiteParsippanyNew Jersey07054-
Novartis Investigative SiteCooperstownNew York13326-
Novartis Investigative SiteGreensboroNorth Carolina27403-
Novartis Investigative SiteCantonOhio44718-
Novartis Investigative SiteWoosterOhio44691-
Novartis Investigative SitePortlandOregon97227-
Novartis Investigative SitePittsburghPennsylvania15212-4772-
Novartis Investigative SiteColumbiaSouth Carolina29210-
Novartis Investigative SiteMemphisTennessee38120-
Novartis Investigative SiteChesapeakeVirginia23320-
Novartis Investigative SiteSalemVirginia24153-
Novartis Investigative SiteBellevueWashington98004-
Novartis Investigative SiteKirklandWashington98034-
Novartis Investigative SiteMount VernonWashington98273-
Novartis Investigative SiteSeattleWashington98109-
Novartis Investigative SiteSequimWashington98382-
Novartis Investigative SiteTacomaWashington98405-
Novartis Investigative SiteWenatcheeWashington98801-
Novartis Investigative SiteMilwaukeeWisconsin53226-

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