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

YM BioSciences

Status and phase: Terminated; Phase 3

Conditions: Breast Cancer; Metastases

Treatments: Drug: YMB 1002

Study type: Interventional

Funder types: Industry

Identifiers

NCT00099281

YMB1002 02

Details and patient eligibility

About

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.

Full description

Endpoints of the trial are as follows:

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

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)