Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin (MyoPac)

Claudia Lorenz-Schlüter

Status and phase: Terminated; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: liposomal Doxorubicin; Drug: Myocet / Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT00691912

4102000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Myocet/Paclitaxel

Experimental group

Description:

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

Treatment:

Drug: Myocet / Paclitaxel

Drug: liposomal Doxorubicin