Maintenance Chemotherapy in Metastatic Breast Cancer

Phase 3

• Conditions: Breast Cancer

• Registration Number: NCT00289263
• Lead Sponsor: MANTA 1 Study Italian Collaborative Group

Brief 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.

Detailed 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 Timeline

• Study Start: 1998-04
• Study Completion: 2003-10
• Status Verified: 2003-11
• Study First Submitted: 2006-02-08
• Study First Submitted QC: 2006-02-08
• Last Update Submitted: 2006-02-08
• Study First Posted: 2006-02-09
• Last Update Posted: 2006-02-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 524

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).

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Exclusion Criteria

• Presence of peripheral neuropathy > grade 2 by NCI Common Toxicity Criteria (NCI-CTC) following induction chemotherapy
• Adjuvant taxane-based therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Time to disease progression with maintenance paclitaxel versus observation

Secondary Outcome Measures

Name	Time	Method
Overall survival
Toxicity
Quality of live
Conversion to a better response

Trial Locations

Locations (7)

Azienda Ospedaliera Pisana; 🇮🇹 Pisa, PI, Italy

Oncology Institute; 🇮🇹 Bari, Italy

National Cancer Research Institute; 🇮🇹 Genoa, Italy

Morgagni-Pierantoni Hospital; 🇮🇹 Forli, Italy

S. Carlo Hospital; 🇮🇹 Potenza, Italy

Santa Maria Nuova Hospital; 🇮🇹 Reggio Emilia, Italy

University of Rome; 🇮🇹 Rome, Italy