NCT01873833

Capecitabine, Cyclophosphamide, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With HER2-Positive Metastatic Breast Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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.

Conditions

• HER2-positive Breast Cancer
• Recurrent Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DRUG	capecitabine	Given PO
DRUG	cyclophosphamide	Given PO
DRUG	lapatinib ditosylate	Given PO
BIOLOGICAL	trastuzumab	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-07-29
• Primary completion: 2021-03-02
• Completion: 2021-03-02
• First posted: 2013-06-10
• Last updated: 2023-10-05
• Results posted: 2023-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study