Maintenance Chemotherapy in Metastatic Breast Cancer

February 8, 2006 updated by: MANTA 1 Study Italian Collaborative Group

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

524

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70010
        • Oncology Institute
      • Forli, Italy, 47100
        • Morgagni-Pierantoni Hospital
      • Genoa, Italy
        • National Cancer Research Institute
      • Potenza, Italy
        • S. Carlo Hospital
      • Reggio Emilia, Italy
        • Santa Maria Nuova Hospital
      • Rome, Italy
        • University of Rome
    • PI
      • Pisa, PI, Italy, 56100
        • Azienda Ospedaliera Pisana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to disease progression with maintenance paclitaxel versus observation

Secondary Outcome Measures

Outcome Measure
Toxicity
Overall survival
Quality of live
Conversion to a better response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MANTA 1 Study Italian Collaborative Group

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: PierFranco Conte, MD, University of Modena, Italy
  • Principal Investigator: Dino Amadori, MD, Morgagni-Pierantoni Hospital, Forli, Italy
  • Principal Investigator: Mario Delena, MD, Oncology Institute, Bari, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1998

Study Completion

October 1, 2003

Study Registration Dates

First Submitted

February 8, 2006

First Submitted That Met QC Criteria

February 8, 2006

First Posted (Estimate)

February 9, 2006

Study Record Updates

Last Update Posted (Estimate)

February 9, 2006

Last Update Submitted That Met QC Criteria

February 8, 2006

Last Verified

November 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MANTA1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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