Status:
UNKNOWN
Maintenance Chemotherapy in Metastatic Breast Cancer
Lead Sponsor:
MANTA 1 Study Italian Collaborative Group
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
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.
Detailed 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 pac...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Presence of peripheral neuropathy \> grade 2 by NCI Common Toxicity Criteria (NCI-CTC) following induction chemotherapy
- Adjuvant taxane-based therapy
Key Trial Info
Start Date :
April 1 1998
Trial Type :
INTERVENTIONAL
End Date :
October 1 2003
Estimated Enrollment :
524 Patients enrolled
Trial Details
Trial ID
NCT00289263
Start Date
April 1 1998
End Date
October 1 2003
Last Update
February 9 2006
Active Locations (7)
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1
Azienda Ospedaliera Pisana
Pisa, PI, Italy, 56100
2
Oncology Institute
Bari, Italy, 70010
3
Morgagni-Pierantoni Hospital
Forlì, Italy, 47100
4
National Cancer Research Institute
Genoa, Italy