At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed invasive breast cancer with stage IV disease
- ✓Documented ErbB2 amplification by FISH in primary or metastatic tumor tissue
- ✓Measurable disease per RECIST
- ✓ECOG Performance Status 0 to 1
- ✕Only non-measurable metastatic sites per RECIST (e.g., bone metastases, pleural effusion, ascites)
- ✕Prior chemotherapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for metastatic disease
- ✕Prior ErbB1/ErbB2 inhibitor therapy (except trastuzumab in adjuvant setting with >12 months washout)
- ✕Peripheral neuropathy Grade 2 or greater
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Study of Lapatinib (GW572016) in Combination With Paclitaxel Versus Paclitaxel Plus Placebo in Subjects With ErbB2 Amplified Metastatic Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Lapatinib (GW572016) oral tablets, Paclitaxel infusion, and 1 other intervention for Neoplasms, Breast. Completed, enrolled 444 participants across 54 sites in 8 countries.
Detailed Summary
This was a randomized, double-blind, placebo-controlled, multicenter, Phase III study to evaluate and compare the efficacy and safety of Lapatinib + Paclitaxel versus Placebo + Paclitaxel in men and women with ErbB2 amplified metastatic (Stage IV) breast cancer who had not received prior therapy for metastatic disease.
Study Details
Timeline
Interventions
1500 mg oral daily continuously
Paclitaxel 80 mg/m2 every 3 weeks, 4th week rest for minimum 6 months
Paclitaxel Matching Placebo