Back to resultsDPPE in Combination With Epirubicin and Cyclophosphamide in the Treatment of Breast Cancer
Primary Purpose
Breast Cancer, Metastases
Status
Terminated
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
YMB 1002
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Metastatic breast cancer
Eligibility Criteria
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
Sites / Locations
- PharmOlam
Outcomes
Primary Outcome Measures
Overall survival
Secondary Outcome Measures
Response rate
Progression-free survival
Toxicity
Neurocognitive function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00099281
Brief Title
DPPE in Combination With Epirubicin and Cyclophosphamide in the Treatment of Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Terminated
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
YM BioSciences
4. Oversight
5. Study Description
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:
Prior cytotoxic treatment;
Estrogen receptor status;
ECOG performance status;
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Metastases
Keywords
Metastatic breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
YMB 1002
Primary Outcome Measure Information:
Title
Overall survival
Secondary Outcome Measure Information:
Title
Response rate
Title
Progression-free survival
Title
Toxicity
Title
Neurocognitive function
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Pritchard, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Study Chair
Facility Information:
Facility Name
PharmOlam
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
DPPE in Combination With Epirubicin and Cyclophosphamide in the Treatment of Breast Cancer
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