Eric,
Here is the link and full text of Wyeth's Phase III study that is now enrolling patients all over the country. Make sure to click on the link further down the webpage that says "Show 111 Study Locations", to find the site nearest to you.
http://clinicaltrials.gov/show/NCT00777101
Study Evaluating Neratinib vs Lapatinib Plus Capecitabine for ErbB2 Positive Advanced Breast Cancer
This study is currently recruiting participants.
Verified by Wyeth, June 2009
First Received: October 21, 2008 Last Updated: June 16, 2009
History of Changes
Sponsored by:
Wyeth
Information provided by: WyethClinicalTrials.gov Identifier: NCT00777101
Purpose 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.
Study Type:InterventionalStudy Design:Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy StudyOfficial Title:A 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
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer Cancer
Drug Information available for:
Capecitabine Lapatinib Lapatinib Ditosylate HKI-272
U.S. FDA Resources
Further study details as provided by Wyeth:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: 16 Week ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Common Terminology Criteria for Adverse Events [CTCAE] V3 [ Time Frame: Subject's duration on active portion of the study. ] [ Designated as safety issue: Yes ]
Estimated Enrollment:1000Study Start Date:November 2008Estimated Study Completion Date:November 2013Estimated Primary Completion Date:November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions A: Experimental Neratinib
Drug: Neratinib B: Active Comparator Lapatinib plus Capecitabine
Drug: Lapatinib plus Capecitabine
Eligibility
Ages Eligible for Study: 18 Years and olderGenders Eligible for Study: FemaleAccepts Healthy Volunteers: NoCriteria
Potential subjects should have/be:
- Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
- Prior use of Herceptin (trastuzumab), an anthracycline, and a taxane
- Adequate cardiac and renal function
Potential subjects should not have:
- More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]
- Bone or skin as the only site of disease
- Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
- Sigificant gastrointestinal disorder with diarrhea as major symptom