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

Tracking Information

First Received Date ^ICMJE

June 4, 2008

Last Updated Date

July 12, 2010

Start Date ^ICMJE

December 2006

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

progression free survival [ Time Frame: in cycle 3, at the end of therapy, during follow-up ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00691912 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin

Official Title ^ICMJE

Extended Dose Frequency 1st-line Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin (Myocet®)

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Metastatic Breast Cancer

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2016

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Joachim Bischoff, Dr. med.

39-1671-7301

joachim.bischoff@medizin.uni-magdeburg.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00691912

Other Study ID Numbers ^ICMJE

4102000

Has Data Monitoring Committee

Responsible Party

Joachim Bischoff, Dr. med., Klinikum der Otto-von-Guericke Universität, Frauenklinik

Study Sponsor ^ICMJE

University of Magdeburg

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Joachim Bischoff, Dr. med.

Klinikum der Otto-von-Guericke Universität Magdeburg, Frauenklinik

Information Provided By

University of Magdeburg

Verification Date

June 2008

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

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