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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00289263
• Other study ID #: MANTA1
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 8, 2006
• Last updated: February 8, 2006
• Start date: April 1998
• Est. completion date: October 2003

Study information

• Verified date: November 2003
• Source: MANTA 1 Study Italian Collaborative Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 524
• Est. completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

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

Intervention

Drug:
• Paclitaxel

Locations

Country	Name	City	State
Italy	Oncology Institute	Bari
Italy	Morgagni-Pierantoni Hospital	Forli
Italy	National Cancer Research Institute	Genoa
Italy	Azienda Ospedaliera Pisana	Pisa	PI
Italy	S. Carlo Hospital	Potenza
Italy	Santa Maria Nuova Hospital	Reggio Emilia
Italy	University of Rome	Rome

Sponsors (2)

Lead Sponsor	Collaborator
MANTA 1 Study Italian Collaborative Group	Bristol-Myers Squibb

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to disease progression with maintenance paclitaxel versus observation
Secondary	Overall survival
Secondary	Toxicity
Secondary	Quality of live
Secondary	Conversion to a better response