Maintenance Chemotherapy in Metastatic Breast Cancer
This trial is active, not recruiting.
|Sponsor||MANTA 1 Study Italian Collaborative Group|
|Start date||April 1998|
|End date||October 2003|
|Trial size||524 participants|
|Trial identifier||NCT00289263, MANTA1|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Pisa, Italy||Azienda Ospedaliera Pisana||no longer recruiting|
|Bari, Italy||Oncology Institute||no longer recruiting|
|Forli, Italy||Morgagni-Pierantoni Hospital||no longer recruiting|
|Genoa, Italy||National Cancer Research Institute||no longer recruiting|
|Potenza, Italy||S. Carlo Hospital||no longer recruiting|
|Reggio Emilia, Italy||Santa Maria Nuova Hospital||no longer recruiting|
|Rome, Italy||University of Rome||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Time to disease progression with maintenance paclitaxel versus observation
Quality of live
Conversion to a better response
Female participants from 18 years up to 70 years old.
- Written informed consent.
- Patients with metastatic breast cancer in response or stable disease after six to eight courses of first line induction chemotherapy treatment
- Measurable and/or evaluable disease
- Performance status ECOG 0, 1, 2.
- Normal cardiac function, confirmed by left ventricular ejection fraction (LVEF).
- Presence of peripheral neuropathy > grade 2 by NCI Common Toxicity Criteria (NCI-CTC) following induction chemotherapy
- Adjuvant taxane-based therapy
|Official title||Maintenance Paclitaxel Vs Control After Anthracycline/Paclitaxel Combined First-Line Chemotherapy in Metastatic Breast Cancer|
|Principal investigator||PierFranco Conte, MD|
|Description||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.|
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