Maintenance Chemotherapy in Metastatic Breast Cancer
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Maintenance Paclitaxel Vs Control After Anthracycline/Paclitaxel Combined First-Line Chemotherapy in Metastatic Breast Cancer|
- Time to disease progression with maintenance paclitaxel versus observation
- Overall survival
- Quality of live
- Conversion to a better response
|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.
|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|