drugset / Trial / NCT00281658
Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2006-01-02
- Primary completion
- 2010-06-18
- Completion
- 2021-11-23
Outcome
Met primary endpoint
paper The addition of lapatinib to paclitaxel significantly improved OS versus paclitaxel (treatment hazard ratio [HR], 0.74; 95% CI, 0.58 to 0.94; P = .0124); PMID 23509322 ↗
registry p = 0.0062; Hazard Ratio (HR) 0.74 (95% CI 0.58 to 0.94); Log Rank; note: Stratified Log-Rank (one-sided) NCT00281658 ↗
Publications
- Xu B, Guan Z, Shen Z, Tong Z, Jiang Z, Yang J, DeSilvio M, Russo M, Leigh M, Ellis C. Association of phosphatase and tensin homolog low and phosphatidylinositol 3-kinase catalytic subunit alpha gene mutations on outcome in human epidermal growth factor receptor 2-positive metastatic breast cancer patients treated with first-line lapatinib plus paclitaxel or paclitaxel alone. Breast Cancer Res. 2014 Jul 24;16(4):405. doi: 10.1186/s13058-014-0405-y.
- Guan Z, Xu B, DeSilvio ML, Shen Z, Arpornwirat W, Tong Z, Lorvidhaya V, Jiang Z, Yang J, Makhson A, Leung WL, Russo MW, Newstat B, Wang L, Chen G, Oliva C, Gomez H. Randomized trial of lapatinib versus placebo added to paclitaxel in the treatment of human epidermal growth factor receptor 2-overexpressing metastatic breast cancer. J Clin Oncol. 2013 Jun 1;31(16):1947-53. doi: 10.1200/JCO.2011.40.5241. Epub 2013 Mar 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lapatinib | Small molecule | 1500 mg | Oral |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |