Maintenance Chemotherapy in Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring metastatic breast cancer, maintenance chemotherapy
Eligibility Criteria
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
Sites / Locations
- Azienda Ospedaliera Pisana
- Oncology Institute
- Morgagni-Pierantoni Hospital
- National Cancer Research Institute
- S. Carlo Hospital
- Santa Maria Nuova Hospital
- University of Rome
Outcomes
Primary Outcome Measures
Time to disease progression with maintenance paclitaxel versus observation
Secondary Outcome Measures
Overall survival
Toxicity
Quality of live
Conversion to a better response
Full Information
NCT ID
NCT00289263
First Posted
February 8, 2006
Last Updated
February 8, 2006
Sponsor
MANTA 1 Study Italian Collaborative Group
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00289263
Brief Title
Maintenance Chemotherapy in Metastatic Breast Cancer
Official Title
Maintenance Paclitaxel Vs Control After Anthracycline/Paclitaxel Combined First-Line Chemotherapy in Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2003
Overall Recruitment Status
Unknown status
Study Start Date
April 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
MANTA 1 Study Italian Collaborative Group
Collaborators
Bristol-Myers Squibb
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
metastatic breast cancer, maintenance chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
524 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Primary Outcome Measure Information:
Title
Time to disease progression with maintenance paclitaxel versus observation
Secondary Outcome Measure Information:
Title
Overall survival
Title
Toxicity
Title
Quality of live
Title
Conversion to a better response
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PierFranco Conte, MD
Organizational Affiliation
University of Modena, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dino Amadori, MD
Organizational Affiliation
Morgagni-Pierantoni Hospital, Forli, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mario Delena, MD
Organizational Affiliation
Oncology Institute, Bari, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera Pisana
City
Pisa
State/Province
PI
ZIP/Postal Code
56100
Country
Italy
Facility Name
Oncology Institute
City
Bari
ZIP/Postal Code
70010
Country
Italy
Facility Name
Morgagni-Pierantoni Hospital
City
Forli
ZIP/Postal Code
47100
Country
Italy
Facility Name
National Cancer Research Institute
City
Genoa
Country
Italy
Facility Name
S. Carlo Hospital
City
Potenza
Country
Italy
Facility Name
Santa Maria Nuova Hospital
City
Reggio Emilia
Country
Italy
Facility Name
University of Rome
City
Rome
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Maintenance Chemotherapy in Metastatic Breast Cancer
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