Trial Information

Maintenance Paclitaxel Vs Control After Anthracycline/Paclitaxel Combined First-Line Chemotherapy in Metastatic Breast Cancer

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.