Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin

Study Overview
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Brief Summary
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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
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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.

Official Title
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Extended Dose Frequency 1st-line Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin (Myocet®)

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: liposomal Doxorubicin
* Drug: Myocet / Paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myocet/Paclitaxel<br>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 | Drug: liposomal Doxorubicin<br>* 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<br>* Other names: Myocet;Drug: Myocet / Paclitaxel<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival assessed by imaging procedures |  | after 6 weeks, 12 weeks, 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |