Clinical trial NCT00691912: Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin
Official title: Extended Dose Frequency 1st-line Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin (Myocet®)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: progression free survival assessed by imaging procedures
timeFrame: after 6 weeks, 12 weeks, 18 weeks
Secondary outcomes:
measure: toxicity, quality of life
timeFrame: every 3 weeks
measure: response rate, overall survival
timeFrame: 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.
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Klinikum der Otto-von Guericke Universität Magdeburg, Frauenklinik
state: Sachsen-Anhalt
Study officials:
affiliation: Klinikum der Otto-von-Guericke Universität Magdeburg, Frauenklinik
name: Joachim Bischoff, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: