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

September 1, 2014 updated by: Claudia Lorenz-Schlüter

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39108
        • Klinikum der Otto-von Guericke Universität Magdeburg, Frauenklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival assessed by imaging procedures
Time Frame: after 6 weeks, 12 weeks, 18 weeks
after 6 weeks, 12 weeks, 18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
toxicity, quality of life
Time Frame: every 3 weeks
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Claudia Lorenz-Schlüter

Investigators

  • Principal Investigator: Joachim Bischoff, Dr. med., Klinikum der Otto-von-Guericke Universität Magdeburg, Frauenklinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

September 3, 2014

Last Update Submitted That Met QC Criteria

September 1, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4102000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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