DPPE in Combination With Epirubicin and Cyclophosphamide in the Treatment of Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase III Study of DPPE Combined With Epirubicin and Cyclophosphamide vs Epirubicin and Cyclophosphamide Alone as First Line Treatment in Metastatic/Recurrent Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00099281
• Other study ID #: YMB1002 02
• Status: Terminated
• Phase: Phase 3
• First received: December 10, 2004
• Last updated: February 27, 2007
• Start date: May 2004
• Est. completion date: June 2006

Study information

• Verified date: February 2007
• Source: YM BioSciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to study DPPE combined with epirubicin and cyclophosphamide in patients with metastatic and/or recurrent breast cancer who may have received previous hormone treatment but have not had exposure to anthracycline treatment. Stratification allocation will be within the following subgroups:

1. Prior cytotoxic treatment;

2. Estrogen receptor status;

3. ECOG performance status;

4. Number of cycles of chemotherapy.

Description:

Endpoints of the trial are as follows:

primary: overall survival; secondary: response rate, progression free survival, toxicity, neurocognitive function.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 700
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Histological proof of breast cancer

• Documented evidence of metastatic and/or recurrent breast cancer

• Presence of at least one bi-dimensional or uni-dimensional lesion

• ECOG status 0, 1 or 2

• Quality of life

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastases

Intervention

Drug:
• YMB 1002

Locations

Country	Name	City	State
United Kingdom	PharmOlam	London

Sponsors (1)

Lead Sponsor	Collaborator
YM BioSciences

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival
Secondary	Response rate
Secondary	Progression-free survival
Secondary	Toxicity
Secondary	Neurocognitive function