Trials / Terminated
TerminatedNCT00099281
DPPE in Combination With Epirubicin and Cyclophosphamide in the Treatment of Breast Cancer
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 700 (planned)
- Sponsor
- YM BioSciences · Industry
- Sex
- Female
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | YMB 1002 |
Timeline
- Start date
- 2004-05-01
- Completion
- 2006-06-01
- First posted
- 2004-12-10
- Last updated
- 2007-02-28
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00099281. Inclusion in this directory is not an endorsement.