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

This study is currently recruiting participants.
Verified June 2008 by University of Magdeburg
Sponsor:
Information provided by:
University of Magdeburg
ClinicalTrials.gov Identifier:
NCT00691912
First received: June 4, 2008
Last updated: July 12, 2010
Last verified: June 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
 Drug: liposomal Doxorubicin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extended Dose Frequency 1st-line Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin (Myocet®)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Magdeburg:

Primary Outcome Measures:
  • progression free survival assessed by imaging procedures [ Time Frame: after 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 6
Study Start Date: December 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women >/= 18 years with histologically proven metastatic breast cancer
  • No prior chemotherapy in the advanced situation
  • ECPG </= 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691912

Contacts
Contact: Joachim Bischoff, Dr. med. 39-1671-7301 joachim.bischoff@medizin.uni-magdeburg.de

Locations
Germany
Klinikum der Otto-von Guericke Universität Magdeburg, Frauenklinik Recruiting
Magdeburg, Sachsen-Anhalt, Germany, 39108
Sponsors and Collaborators
University of Magdeburg
Investigators
Principal Investigator: Joachim Bischoff, Dr. med. Klinikum der Otto-von-Guericke Universität Magdeburg, Frauenklinik
  More Information

No publications provided

Responsible Party: Joachim Bischoff, Dr. med., Klinikum der Otto-von-Guericke Universität, Frauenklinik
ClinicalTrials.gov Identifier: NCT00691912     History of Changes
Other Study ID Numbers: 4102000
Study First Received: June 4, 2008
Last Updated: July 12, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Paclitaxel
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 18, 2013