Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin

Metastatic Breast Cancer Clinical Trial

— MyoPac  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00691912
• Other study ID #: 4102000
• Status: Terminated
• Phase: Phase 2
• First received: June 4, 2008
• Last updated: September 1, 2014
• Start date: December 2006
• Est. completion date: December 2013

Study information

• Verified date: September 2014
• Source: University of Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Klinikum der Otto-von Guericke Universität Magdeburg, Frauenklinik	Magdeburg	Sachsen-Anhalt

Sponsors (1)

Lead Sponsor	Collaborator
Claudia Lorenz-Schlüter

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival assessed by imaging procedures		after 6 weeks, 12 weeks, 18 weeks	No
Secondary	toxicity, quality of life		every 3 weeks	Yes
Secondary	response rate, overall survival		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.	No