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

Phase 3

Terminated

• Conditions: Breast Cancer; Metastases

• Registration Number: NCT00099281
• Lead Sponsor: YM BioSciences

Brief 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.

Detailed Description

Endpoints of the trial are as follows:

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

Study Timeline

• Study Start: 2004-05
• Study First Submitted QC: 2004-12-09
• Study First Submitted: 2004-12-10
• Study First Posted: 2004-12-10
• Study Completion: 2006-06
• Status Verified: 2007-02
• Last Update Submitted: 2007-02-27
• Last Update Posted: 2007-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 700

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Response rate
Progression-free survival
Toxicity
Neurocognitive function

Trial Locations

Locations (1)

PharmOlam; 🇬🇧 London, United Kingdom