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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2006-06-30

Brief Summary

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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

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Endpoints of the trial are as follows:

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

Conditions

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Breast Cancer Metastases

Keywords

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Metastatic breast cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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YMB 1002

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Kathleen Pritchard, MD

Role: STUDY_CHAIR

Sunnybrook Health Sciences Centre

Locations

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PharmOlam

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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YMB1002 02

Identifier Type: -

Identifier Source: org_study_id