A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer

Tracking Information

Start Date  ICMJEFebruary 2005
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: January 18, 2008)
Tumor response rate and progression [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: May 17, 2007)
Efficacy: Tumor response rate and progression
Change HistoryComplete list of historical versions of study NCT00475670 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: January 18, 2008)
  • Duration of response, PFS, time to treatment failure, clinical benefit rate, survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, hematologic and biochemical parameters, LVEF. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: May 17, 2007)
Efficacy: Duration of response, progression-free survival, time to treatment failure, clinical benefit rate, survival. Safety: Adverse events, hematologic and biochemical parameters, LVEF.

Descriptive Information

Brief Title  ICMJEA Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer
Official Title  ICMJEAn Open-label Study of the Effect of First-line Herceptin Alone or in Combination With a Taxane on Tumor Response and Disease Progression in Patients With Metastatic Breast Cancer Who Relapsed After Receiving Adjuvant Herceptin for HER2-positive Early Breast Cancer
Brief Summary

This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without a taxane for the first line treatment of metastatic breast cancer in women who have relapsed at least 12 months after a minimum of 10 months of (neo)adjuvant treatment with Herceptin for HER2-positive early breast cancer.Patients will receive either Herceptin monotherapy (loading dose of 4mg/kg iv, followed by weekly doses of 2mg/kg iv, or 8mg/kg loading dose followed by 3-weekly doses of 6mg/kg)or Herceptin + a taxane (docetaxel 100mg/m2 iv every 3 weeks, or paclitaxel 175mg/m2 iv every 3 weeks or 75mg/m2 every week). The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEBreast Cancer
Intervention  ICMJE
  • Drug: trastuzumab [Herceptin]
    4mg/kg iv loading dose followed by 2mg/kg iv weekly, or 8mg/kg iv loading dose followed by 6mg/kg iv 3-weekly
  • Drug: Taxane (docetaxel or paclitaxel)
    As prescribed
Study Arms / Comparison Groups
  • 1: Experimental
    • Drug: trastuzumab [Herceptin]
    • Drug: Taxane (docetaxel or paclitaxel)
  • 2: Active Comparator
    Intervention: Drug: trastuzumab [Herceptin]

Recruitment Information

Estimated Enrollment  ICMJE40
Estimated Completion DateMay 2011
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • at least 10 months of Herceptin treatment for HER2-positive early breast cancer;
  • metastatic breast cancer >=12 months after discontinuation of Herceptin;
  • measurable disease.

Exclusion Criteria:

  • previous chemotherapy for metastatic breast cancer;
  • brain metastases;
  • invasive malignancy other than metastatic breast cancer.
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: WO17299888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEAustralia,   Austria,   Belgium,   Brazil,   Canada,   China,   Germany,   Hungary,   Italy,   Mexico,   Panama,   Poland,   Russian Federation,   Spain,   Taiwan

Administrative Information

Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEWO17299
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche