Capecitabine, Cyclophosphamide, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With HER2-Positive Metastatic Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- HER2 Positive Breast Cancer
- Recurrent Breast Cancer
- Stage IV Breast Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
PRIMARY OBJECTIVES: I. To estimate the progression free survival (PFS). SECONDARY OBJECTIVES: 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 surviva...
PRIMARY OBJECTIVES: I. To estimate the progression free survival (PFS). SECONDARY OBJECTIVES: 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. OUTLINE: 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.
Tracking Information
- NCT #
- NCT01873833
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Darcy V Spicer, MD University of Southern California
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