Maintenance Chemotherapy in Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00289263|
Recruitment Status : Unknown
Verified November 2003 by MANTA 1 Study Italian Collaborative Group.
Recruitment status was: Active, not recruiting
First Posted : February 9, 2006
Last Update Posted : February 9, 2006
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Paclitaxel||Phase 3|
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 (Clinical Trial)|
|Enrollment :||524 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Maintenance Paclitaxel Vs Control After Anthracycline/Paclitaxel Combined First-Line Chemotherapy in Metastatic Breast Cancer|
|Study Start Date :||April 1998|
|Study Completion Date :||October 2003|
- Time to disease progression with maintenance paclitaxel versus observation
- Overall survival
- Quality of live
- Conversion to a better response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289263
|Azienda Ospedaliera Pisana|
|Pisa, PI, Italy, 56100|
|Bari, Italy, 70010|
|Forli, Italy, 47100|
|National Cancer Research Institute|
|S. Carlo Hospital|
|Santa Maria Nuova Hospital|
|Reggio Emilia, Italy|
|University of Rome|
|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|