Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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.)
Information provided by (Responsible Party):
Claudia Lorenz-Schlüter, University of Magdeburg Identifier:
First received: June 4, 2008
Last updated: September 1, 2014
Last verified: September 2014
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
Drug: Myocet / Paclitaxel
Phase 2

Study Type: Interventional
Study Design: 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:

Further study details as provided by Claudia Lorenz-Schlüter, University of Magdeburg:

Primary Outcome Measures:
  • progression free survival assessed by imaging procedures [ Time Frame: after 6 weeks, 12 weeks, 18 weeks ]

Secondary Outcome Measures:
  • toxicity, quality of life [ Time Frame: every 3 weeks ]
  • 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. ]

Enrollment: 26
Study Start Date: December 2006
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00691912

Klinikum der Otto-von Guericke Universität Magdeburg, Frauenklinik
Magdeburg, Sachsen-Anhalt, Germany, 39108
Sponsors and Collaborators
Claudia Lorenz-Schlüter
Principal Investigator: Joachim Bischoff, Dr. med. Klinikum der Otto-von-Guericke Universität Magdeburg, Frauenklinik
  More Information

Responsible Party: Claudia Lorenz-Schlüter, member of CRO, University of Magdeburg Identifier: NCT00691912     History of Changes
Other Study ID Numbers: 4102000
Study First Received: June 4, 2008
Last Updated: September 1, 2014

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on May 25, 2017