Maintenance Chemotherapy in Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title: Maintenance Paclitaxel Vs Control After Anthracycline/Paclitaxel Combined First-Line Chemotherapy in Metastatic Breast Cancer

Status Active, not recruiting

Clinical Trial Summary

This is a randomized, prospective and multicenter phase III study. Two-hundred-sixty-two (262) patients on each arm will be recruited in the study.

Clinical Trial Description

The primary objective is time to disease progression. All patients must be treated with first line chemotherapy, consisting of one of the following regimens: a) ET (epirubicin 90 mg/sqm day 1 plus paclitaxel 200 mg/sqm (3 hour infusion) day 1, or b) AT (doxorubicin 50 mg/sqm day 1 plus paclitaxel 200 mg/sqm (3 hour infusion) day 2, administered on a 3 weekly schedule.

Patients with complete response, partial response or stable disease are eligible for MANTA1 study.

The expected median progression free survival of metastatic breast cancer patients who achieve a disease control after first line chemotherapy was estimated to be 10 months. The minimal improvement, justifying the adoption of maintenance paclitaxel, was estimated to be at least 3 months. With 262 eligible patients on each arm, the trial will have a power of 80% to detect a 30% improvement in median progression free survival, testing at the two-sided .05 significance level. ;

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00289263
• Study type: Interventional
• Source: MANTA 1 Study Italian Collaborative Group
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 1998
• Completion date: October 2003