Rebeccamycin Analogue in Treating Women With Stage IIIB or Stage IV Breast Cancer

Stage IV Breast Cancer Clinical Trial

Official title: A Randomized Phase 2 Study of Rebeccamycin Analog in Advanced Breast Cancer

Status Completed

Clinical Trial Summary

Randomized phase II trial to compare the effectiveness of two regimens of rebeccamycin analogue in treating women who have stage IIIB or stage IV breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. The best way to give rebeccamycin analog in breast cancer patients is not yet known

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the activity of rebeccamycin analog as therapy for advanced breast cancer when administered in two different treatment schedules.

SECONDARY OBJECTIVES:

I. To assess the toxicity associated with administration of rebeccamycin analog therapy in women with advanced breast cancer.

II. To evaluate topoisomerase I and II levels in human lymphocytes following treatment with rebeccamycin analog.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

Arm I: Patients receive rebeccamycin analogue IV over 60 minutes on day 1.

Arm II: Patients receive rebeccamycin analogue IV over 60 minutes on days 1-5.

In all arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Neoplasms, Male
• Male Breast Cancer
• Recurrent Breast Cancer
• Stage IIIB Breast Cancer
• Stage IV Breast Cancer

• NCT number: NCT00005817
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: March 2000