Capecitabine, Cyclophosphamide, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With HER2-Positive Metastatic Breast Cancer
|HER2-positive Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer||Drug: capecitabine Drug: cyclophosphamide Drug: lapatinib ditosylate Biological: trastuzumab Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Metronomic Capecitabine and Cyclophosphamide With Lapatinib and Trastuzumab 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 ]One-sided one-sample logrank test will be used to evaluate the improvement in PFS compared to the reported historical PFS rate.
|Actual Study Start Date:||July 29, 2013|
|Estimated Study Completion Date:||July 27, 2019|
|Estimated Primary Completion Date:||July 27, 2018 (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
|Contact: Kristy Watkins, RN||323-865-0452||Kristy.Watkins@med.usc.edu|
|United States, California|
|USC Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Kristy Watkins, R.N. 323-865-0452 Kristy.Watkins@med.usc.edu|
|Principal Investigator: Darcy v. Spicer, MD|
|Principal Investigator:||Darcy V Spicer, MD||University of Southern California|