CRC 09139: A Randomized, Phase III Study of Lapatinib plus Trastuzumab vs Trastuzumab as Continued HER2 Suppression Therapy after Completion of 1st- or 2nd-line Trastuzumab plus Chemotherapy in Subjects with HER2-positive Metastatic Breast Cancer
- Type of Study
- Cancer (Oncology) - Breast
- Location
- Swedish Cancer Institute
- Short Description
Purpose: This is a randomized, open-label, multi-center Phase III study evaluating the efficacy and safety of lapatinib in combination with trastuzumab versus trastuzumab alone as continued HER2 suppression therapy in women with HER2-positive metastatic breast cancer (MBC).
- Status
- Open to Enrollment
- Principal Investigator
- Erin Ellis, M.D.
- Eligibility Notes
- Histologically verified breast cancer with distant metastases (metastatic breast cancer)
- Documentation of HER2 overexpression or gene amplification in the invasive component of either the primary tumor or metastatic disease site
- Completed 12 to 24 weeks of first- or second-line treatment with trastuzumab in combination with chemotherapy
- Either complete disappearance of all lesions, or persistence of metastatic disease (stable disease) without unequivocal progression or the occurrence of new lesions
- Documentation of lesion response during the course of therapy received prior to randomization (i.e., improvement or no worsening of tumor burden; the absence of new lesions)
- No Eastern Cooperative Oncology Group (ECOG) Performance Status >2
- No prior treatment with anti-HER2 therapy, except trastuzumab or lapatinib
- More Info Link
- Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
- Phone
- (206) 215-3086
- CancerResearch@swedish.org
