A Phase 3 interventional study of Paclitaxel in Breast Cancer, sponsored by MANTA 1 Study Italian Collaborative Group. Status unknown at 7 sites in Italy. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2006-02-09.
Sponsored by MANTA 1 Study Italian Collaborative Group · Phase 3, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 524 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with MANTA 1 Study Italian Collaborative Group as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Time to disease progression with maintenance paclitaxel versus observation
Overall survival
Toxicity
Quality of live
Conversion to a better response
This study is status unknown, as verified in Nov 2003. You cannot join it, but the record below documents what was studied.
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