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

This study has been terminated.
(Study was stopped due because recrutation.was much slower as anticipated.)
Sponsor:
Information provided by (Responsible Party):
Claudia Lorenz-Schlüter, University of Magdeburg
ClinicalTrials.gov Identifier:
NCT00691912
First received: June 4, 2008
Last updated: September 1, 2014
Last verified: September 2014

June 4, 2008
September 1, 2014
December 2006
December 2013   (final data collection date for primary outcome measure)
progression free survival assessed by imaging procedures [ Time Frame: after 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
progression free survival [ Time Frame: in cycle 3, at the end of therapy, during follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00691912 on ClinicalTrials.gov Archive Site
  • toxicity, quality of life [ Time Frame: every 3 weeks ] [ Designated as safety issue: Yes ]
  • response rate, overall survival [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • toxicity, quality of life [ Time Frame: at each cycle ] [ Designated as safety issue: Yes ]
  • response rate, overall survival [ Time Frame: at the end of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin
Extended Dose Frequency 1st-line Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin (Myocet®)

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • 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
    Other Name: Myocet
  • Drug: 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
Experimental: 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:
  • Drug: liposomal Doxorubicin
  • Drug: Myocet / Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
26
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00691912
4102000
No
Claudia Lorenz-Schlüter, University of Magdeburg
Claudia Lorenz-Schlüter
Not Provided
Principal Investigator: Joachim Bischoff, Dr. med. Klinikum der Otto-von-Guericke Universität Magdeburg, Frauenklinik
University of Magdeburg
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP