Lapatinib With Trastuzumab in Treating Patients With HER2-Negative/HER2 Mutant Metastatic Breast Cancer
This phase II trial studies the effectiveness of lapatinib ditosylate (lapatinib) together with trastuzumab in treating patients with HER2-negative breast cancer that carries HER2 gene mutations. Lapatinib may kill tumor cells by blocking some of the enzymes needed for cell division and growth. Trastuzumab, a monoclonal antibody, may block the ability of tumor cells to grow and spread. Giving lapatinib together with trastuzumab may provide a more effective treatment for patients with this type of cancer.
Drug: lapatinib ditosylate
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Lapatinib in Combination With Trastuzumab in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer|
- Overall clinical benefit rate (CBR; CD + PR + SD) of lapatinib and trastuzumab in patients with breast cancer that carry HER2 mutations [ Time Frame: 6 months ] [ Designated as safety issue: No ]Responses assessed using RECIST guidelines version 1.1; duration of SD must be >= 6 months; CBR and its 80% confidence interval will be calculated.
- PFS of patients treated with lapatinib and trastuzumab [ Time Frame: 2 years ] [ Designated as safety issue: No ]Assessed using RECIST guidelines version 1.1
- Correlation of HER2 mutation with histology subtype (invasive lobular vs. invasive ductal cancer) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Correlation of HER2 mutation with tumor grade (1-2 vs. 3) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
- Correlation of HER2 mutation with tumor staging at initial diagnosis (I vs. II or III vs. IV) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Correlation of HER2 mutation with disease free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Occurrence of HER2 mutation in paired primary and metastatic sites [ Time Frame: Baseline ] [ Designated as safety issue: No ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor and monoclonal antibody)
Patients receive lapatinib PO QD on days 1-21 and trastuzumab IV over 90 minutes on day 1 of a 21-day cycle. Treatment continues in the absence of disease progression or unacceptable toxicity.
Drug: lapatinib ditosylate
Other Name: GSK572016, GW-572016, GW2016, Lapatinib, TykerbBiological: trastuzumab
Other Name: anti-c-erB-2, Herceptin, MOAB HER2, MOAB HER2, monoclonal antibody c-erb-2, monoclonal antibody HER2