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| Sponsors and Collaborators: |
MANTA 1 Study Italian Collaborative Group Bristol-Myers Squibb |
|---|---|
| Information provided by: | MANTA 1 Study Italian Collaborative Group |
| ClinicalTrials.gov Identifier: | NCT00289263 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Paclitaxel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Maintenance Paclitaxel Vs Control After Anthracycline/Paclitaxel Combined First-Line Chemotherapy in Metastatic Breast Cancer |
| Estimated Enrollment: | 524 |
| Study Start Date: | April 1998 |
| Estimated Study Completion Date: | October 2003 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| Morgagni-Pierantoni Hospital | |
| Forli, Italy, 47100 | |
| Oncology Institute | |
| Bari, Italy, 70010 | |
| S. Carlo Hospital | |
| Potenza, Italy | |
| Santa Maria Nuova Hospital | |
| Reggio Emilia, Italy | |
| University of Rome | |
| Rome, Italy | |
| National Cancer Research Institute | |
| Genoa, Italy | |
| Italy, PI | |
| Azienda Ospedaliera Pisana | |
| Pisa, PI, Italy, 56100 | |
| 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 |
More Information
| Study ID Numbers: | MANTA1 |
| Study First Received: | February 8, 2006 |
| Last Updated: | February 8, 2006 |
| ClinicalTrials.gov Identifier: | NCT00289263 History of Changes |
| Health Authority: | Italy: Ministry of Health |
|
metastatic breast cancer maintenance chemotherapy |
|
Skin Diseases Paclitaxel Tubulin Modulators Breast Neoplasms |
Antimitotic Agents Antineoplastic Agents, Phytogenic Breast Diseases |
|
Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Breast Neoplasms Antimitotic Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Breast Diseases |
