Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
524 participants
INTERVENTIONAL
1998-04-30
2003-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Paclitaxel
Eligibility Criteria
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Inclusion Criteria
* 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
* Adjuvant taxane-based therapy
18 Years
70 Years
FEMALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
MANTA 1 Study Italian Collaborative Group
OTHER
Principal Investigators
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PierFranco Conte, MD
Role: PRINCIPAL_INVESTIGATOR
University of Modena, Italy
Dino Amadori, MD
Role: PRINCIPAL_INVESTIGATOR
Morgagni-Pierantoni Hospital, Forli, Italy
Mario Delena, MD
Role: PRINCIPAL_INVESTIGATOR
Oncology Institute, Bari, Italy
Locations
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Azienda Ospedaliera Pisana
Pisa, PI, Italy
Oncology Institute
Bari, , Italy
Morgagni-Pierantoni Hospital
Forlì, , Italy
National Cancer Research Institute
Genoa, , Italy
S. Carlo Hospital
Potenza, , Italy
Santa Maria Nuova Hospital
Reggio Emilia, , Italy
University of Rome
Rome, , Italy
Countries
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Other Identifiers
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MANTA1
Identifier Type: -
Identifier Source: org_study_id