Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin
NCT ID: NCT00691912
Last Updated: 2014-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
26 participants
INTERVENTIONAL
2006-12-31
2013-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Claudia Lorenz-Schlüter
OTHER
Responsible Party
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Claudia Lorenz-Schlüter
member of CRO
Principal Investigators
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Joachim Bischoff, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Klinikum der Otto-von-Guericke Universität Magdeburg, Frauenklinik
Locations
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Klinikum der Otto-von Guericke Universität Magdeburg, Frauenklinik
Magdeburg, Saxony-Anhalt, Germany
Countries
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Other Identifiers
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4102000
Identifier Type: -
Identifier Source: org_study_id
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