Breast Cancer, Metastases
Conditions
Keywords
Metastatic breast cancer
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.
Interventions
DRUGYMB 1002
Sponsors
YM BioSciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate | — |
| Progression-free survival | — |
| Toxicity | — |
| Neurocognitive function | — |
Countries
United Kingdom
Outcome results
None listed