Lapatinib and Tamoxifen in Treating Patients With Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Previous Tamoxifen
This phase II trial is studying how well giving lapatinib together with tamoxifen works in treating patients with locally advanced or metastatic breast cancer that did not respond to previous tamoxifen. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Sometimes when tamoxifen is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to tamoxifen. Giving lapatinib together with tamoxifen may reduce drug resistance and allow the tumor cells to be killed.
Male Breast Cancer
Recurrent Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Drug: lapatinib ditosylate
Drug: tamoxifen citrate
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of GW572016 and Tamoxifen in Patients With Metastatic Breast Cancer Resistant to Single-Agent Tamoxifen|
- Tumor Response Rate (Complete and Partial) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Changes in Phosphorylation in Tumor Tissue of Epidermal Growth Factor Receptor (EGFR), HER2, AKT Kinase, MAPK, ER-Ser118, and ER-SER167 [ Time Frame: Baseline and at 21 days ] [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.
Drug: lapatinib ditosylate
Given orallyDrug: tamoxifen citrate
I. Determine the response rate (complete response and partial response) in patients with tamoxifen-resistant locally advanced or metastatic breast cancer treated with lapatinib and tamoxifen.
II. To describe the changes in phosphorylation of EGFR, her2, AKT kinase, MAPK, ER-Ser118, and ER-Ser167 in tumor tissue after administration of tamoxifen and GW572016.
OUTLINE: This is a multicenter study.
Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples are collected at baseline and at 21 days after the beginning of study therapy for phosphorylation of EGFR, her2, AKT kinase, MAPK, ER-Ser118, and ER-Ser167 analysis by IHC and Western blot assays.
After completion of study treatment, patients are followed at 1 month and then every 3 months thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118157
|United States, Michigan|
|Wayne State University|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Elaina Gartner||Wayne State University|