Study Evaluating Neratinib vs Lapatinib Plus Capecitabine for ErbB2 Positive Advanced Breast Cancer


Tracking Information

Start Date  ICMJENovember 2008
Estimated Primary Completion DateNovember 2013   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2008)		Progression Free Survival [ Time Frame: 16 Week ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00777101 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: February 19, 2009)		Common Terminology Criteria for Adverse Events [CTCAE] V3 [ Time Frame: Subject's duration on active portion of the study. ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJE 
 (submitted: October 21, 2008)		Common Terminology Criteria for Adverse Events [CTCAE] V3 [ Time Frame: Duration of subject's participation on active portion of the study ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title  ICMJEStudy Evaluating Neratinib vs Lapatinib Plus Capecitabine for ErbB2 Positive Advanced Breast Cancer
Official Title  ICMJEA Phase 3 Randomized Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine for the Treatment of ErbB-2 Positive Locally Advanced or Metastatic Breast Cancer
Brief Summary

This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Advanced Breast Cancer
  • Breast Cancer
Intervention  ICMJE
  • Drug: Neratinib
  • Drug: Lapatinib plus Capecitabine
Study Arms / Comparison Groups
  • A: Experimental
    Neratinib
    Intervention: Drug: Neratinib
  • B: Active Comparator
    Lapatinib plus Capecitabine
    Intervention: Drug: Lapatinib plus Capecitabine

Recruitment Information

Estimated Enrollment  ICMJE1000
Estimated Completion DateNovember 2013
Estimated Primary Completion DateNovember 2013   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Potential subjects should have/be:

  1. Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
  2. Prior use of Herceptin (trastuzumab), and a taxane
  3. Adequate cardiac and renal function

Potential subjects should not have:

  1. More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]
  2. Bone as the only site of disease
  3. Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
  4. Sigificant gastrointestinal disorder with diarrhea as major symptom
GenderFemale
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Trial Managerclintrialparticipation@wyeth.com
Location Countries  ICMJEUnited States,   Australia,   Belgium,   Bulgaria,   Canada,   Croatia,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Italy,   Japan,   Jordan,   Korea, Republic of,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovenia,   South Africa,   Spain,   Switzerland,   Taiwan,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00777101
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study ID Numbers  ICMJE3144A2-3003
Study Sponsor  ICMJEWyeth
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Medical MonitorWyeth
Information Provided ByWyeth