Trastuzumab & Capecitabine in Treating Women With Metastatic Breast Cancer

Status Completed

Clinical Trial Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab together with capecitabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving trastuzumab together with capecitabine works in treating women with metastatic breast cancer.

Clinical Trial Description

OBJECTIVES:

Primary

- Determine the median survival time and 2-year survival rate in women with taxane- and anthracycline-refractory HER2/neu-overexpressing metastatic breast cancer treated with trastuzumab (Herceptin®) and capecitabine.

Secondary

- Determine the progression-free survival of patients treated with this regimen.

- Determine the response rate in patients treated with this regimen.

- Determine the clinical benefit rate of this regimen in these patients.

- Determine the safety profile of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment with trastuzumab (Herceptin®) (yes vs no), HER2/neu status (3+ by immunohistochemistry vs positive by fluorescence in situ hybridization), and class of refractory disease (primary vs secondary vs treatment discontinuation due to adverse events).

Patients receive oral capecitabine once daily on days 1-21 and trastuzumab IV on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for up to 2 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 3 years. ;

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00107393
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 2
Start date	June 2003
Completion date	November 2008

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Trastuzumab and Capecitabine in Treating Women With Metastatic Breast Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms