Capecitabine, Cyclophosphamide, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With HER2-Positive Metastatic Breast Cancer
This phase II trial studies how well capecitabine, cyclophosphamide, lapatinib ditosylate, and trastuzumab work in treating patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine and cyclophosphamide daily may kill more tumor cells. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of the tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving capecitabine, cyclophosphamide, lapatinib ditosylate, and trastuzumab together may be an effective treatment for breast cancer.
HER2-positive Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Drug: lapatinib ditosylate
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Metronomic Capecitabine and Cyclophosphamide With Lapatinib and Ttrastuzumab in Patients With HER2 Positive Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-Based Regimen|
- PFS [ Time Frame: From the date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 1 year ] [ Designated as safety issue: No ]One-sided one-sample logrank test will be used to evaluate the improvement in PFS compared to the reported historical PFS rate.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (chemotherapy, lapatinib ditosylate, trastuzumab)
Patients receive capecitabine PO QD, cyclophosphamide PO QD, and lapatinib ditosylate PO QD on days 1-21 and trastuzumab IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: cyclophosphamide
Other Names:Drug: lapatinib ditosylate
Other Names:Biological: trastuzumab
Other Names:Other: laboratory biomarker analysis
I. To estimate the progression free survival (PFS).
I. To evaluate the overall response rate (ORR).
II. To evaluate the clinical benefit rate (CBR; complete response, partial response, and stable disease for >= 24 weeks).
III. To estimate the overall survival (OS).
IV. To assess the safety and tolerability.
Patients receive capecitabine orally (PO) once daily (QD), cyclophosphamide PO QD, and lapatinib ditosylate PO QD on days 1-21 and trastuzumab intravenously (IV) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01873833
|United States, California|
|USC Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Kristy A. Watkins, R.N. 323-865-0452 Kristy.Watkins@med.usc.edu|
|Principal Investigator: Agustin A. Garcia|
|Principal Investigator:||Agustin Garcia||University of Southern California|