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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00691912
Other study ID # 4102000
Secondary ID
Status Terminated
Phase Phase 2
First received June 4, 2008
Last updated September 1, 2014
Start date December 2006
Est. completion date December 2013

Study information

Verified date September 2014
Source University of Magdeburg
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 26
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

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


Related Conditions & MeSH terms


Intervention

Drug:
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
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

Locations

Country Name City State
Germany Klinikum der Otto-von Guericke Universität Magdeburg, Frauenklinik Magdeburg Sachsen-Anhalt

Sponsors (1)

Lead Sponsor Collaborator
Claudia Lorenz-Schlüter

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary progression free survival assessed by imaging procedures after 6 weeks, 12 weeks, 18 weeks No
Secondary toxicity, quality of life every 3 weeks Yes
Secondary 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. No
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