Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin

Phase 2

Terminated

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: liposomal Doxorubicin; Drug: Myocet / Paclitaxel

• Registration Number: NCT00691912
• Lead Sponsor: Claudia Lorenz-Schlüter

Brief 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.

Detailed Description

Breast cancer is the most common malignancy of females. In Germany about 46,000 women come down with breast cancer yearly.

Present therapies cannot cure the metastatic disease, the main focus is improvement of quality of life and prolongation of life. It is therefore necessary to test new substances and/or new combinations and therapy concepts. Among the most active cytotoxic agents used in advanced breast cancer are the anthracyclines. Since conventional anthracyclines are often used as adjuvant or neoadjuvant therapy their cardiotoxicity restricts their use in the therapy of the advanced disease.

Liposomal encapsulated doxorubicin shows better activity than conventional doxorubicin combined with reduced cardiotoxicity.

Weekly applied cytotoxic agents show a better toxicity profile and hence the cumulative dosis can be increased. It is expected that the combination of liposomal encapsulated doxorubicin with paclitaxel given weekly shows improved results in the therapy of metastatic breast cancer.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-01
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

• Women >/= 18 years with histologically proven metastatic breast cancer
• No prior chemotherapy in the advanced situation
• ECOG </= 2
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Myocet/Paclitaxel	liposomal Doxorubicin	20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d
Myocet/Paclitaxel	Myocet / Paclitaxel	20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d

Primary Outcome Measures

Name	Time	Method
progression free survival assessed by imaging procedures	after 6 weeks, 12 weeks, 18 weeks

Secondary Outcome Measures

Name	Time	Method
toxicity, quality of life	every 3 weeks
response rate, overall survival	28 d after last Chemotherapy, up then every 3 months for 1 and a half year, and up then every 6 months until 5 years.

Trial Locations

Locations (1)

Klinikum der Otto-von Guericke Universität Magdeburg, Frauenklinik; 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany