Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Today metastatic breast cancer is regarded as cureless. The treatment is palliative in intent and the goals of treatment include improvement of quality of life and if possible prolongation of life. Treatment in metastatic cancer will usually involve hormone therapy and/or chemotherapy. Weekly application of chemotherapeutical drugs may lead to less drug concentrations in healthy tissue and therefore toxicities maý be reduced.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Claudia Lorenz-Schlüter
• Treatments: Albumin-Bound Paclitaxel; Doxorubicin; Liposomal doxorubicin; Paclitaxel

Criteria

Inclusion Criteria:

• Women >/= 18 years with histologically proven metastatic breast cancer

• No prior chemotherapy in the advanced situation

• ECOG
• Adequate bone marrow reserve

• left ventricular ejection fraction (LVEF) >/= 50, measured within 4 weeks before study treatment

• Existence of written informed consent

Exclusion Criteria:

• Previous high dose therapy with stem cell support

• Prior adjuvant treatment with cumulative anthracycline dose of 600 mg/m² Epirubicin, 300 mg/m² Doxorubicin, 80 mg/m² Mitoxantrone

• Concomitant hormon- or chemotherapy or radiation therapy

• Her2/neu overexpression

• pregnancy or breast feeding