Maintenance Chemotherapy in Metastatic Breast Cancer

• Status: Unknown status
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MANTA 1 Study Italian Collaborative Group
• Collaborator: Bristol-Myers Squibb
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• Presence of peripheral neuropathy > grade 2 by NCI Common Toxicity Criteria (NCI-CTC) following induction chemotherapy

• Adjuvant taxane-based therapy