NCT00099281

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. 1.Prior cytotoxic treatment;
  2. 2.Estrogen receptor status;
  3. 3.ECOG performance status;
  4. 4.Number of cycles of chemotherapy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
Completed

Started May 2004

Shorter than P25 for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

December 10, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

February 28, 2007

Status Verified

February 1, 2007

First QC Date

December 10, 2004

Last Update Submit

February 27, 2007

Conditions

Breast CancerMetastases

Keywords

Metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

Secondary Outcomes (4)

  • Response rate

  • Progression-free survival

  • Toxicity

  • Neurocognitive function

Interventions

YMB 1002DRUG

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PharmOlam

London, United Kingdom

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kathleen Pritchard, MD

    Sunnybrook Health Sciences Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 10, 2004

First Posted

December 10, 2004

Study Start

May 1, 2004

Study Completion

June 1, 2006

Last Updated

February 28, 2007

Record last verified: 2007-02

Locations

GB(1)