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

Phase 2
18 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

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

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.

Inclusion Criteria:

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

- No prior chemotherapy in the advanced situation

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival assessed by imaging procedures

Outcome Time Frame:

after 6 weeks, 12 weeks, 18 weeks

Safety Issue:


Principal Investigator

Joachim Bischoff, Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinikum der Otto-von-Guericke Universität Magdeburg, Frauenklinik


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

December 2006

Completion Date:

December 2016

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms