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

Phase 3TerminatedNCT00099281

YM BioSciences700 enrolled

Overview

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.

Endpoints of the trial are as follows: primary: overall survival; secondary: response rate, progression free survival, toxicity, neurocognitive function.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

700

Conditions

Breast Cancer Metastases

Interventions

YMB 1002DRUG

Eligibility

Sex: FEMALEMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

PharmOlam

London, United Kingdom

Outcomes

Primary Outcomes

Overall survival

Secondary Outcomes

Response rate

Progression-free survival

Toxicity

Neurocognitive function

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.