Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment paclitaxel
Phase phase 3
Sponsor MANTA 1 Study Italian Collaborative Group
Collaborator Bristol-Myers Squibb
Start date April 1998
End date October 2003
Trial size 524 participants
Trial identifier NCT00289263, MANTA1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Time to disease progression with maintenance paclitaxel versus observation
time frame:

Secondary Outcomes

Measure
Overall survival
time frame:
Toxicity
time frame:
Quality of live
time frame:
Conversion to a better response
time frame:

Eligibility Criteria

Female participants from 18 years up to 70 years old.

Inclusion Criteria: - Written informed consent. - Patients with metastatic breast cancer in response or stable disease after six to eight courses of first line induction chemotherapy treatment - Measurable and/or evaluable disease - Performance status ECOG 0, 1, 2. - Normal cardiac function, confirmed by left ventricular ejection fraction (LVEF). Exclusion Criteria: - Presence of peripheral neuropathy > grade 2 by NCI Common Toxicity Criteria (NCI-CTC) following induction chemotherapy - Adjuvant taxane-based therapy

Additional Information

Official title Maintenance Paclitaxel Vs Control After Anthracycline/Paclitaxel Combined First-Line Chemotherapy in Metastatic Breast Cancer
Principal investigator PierFranco Conte, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2006.
Information provided to ClinicalTrials.gov by MANTA 1 Study Italian Collaborative Group.