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

This study has been terminated.
Sponsor:
Information provided by:
YM BioSciences
ClinicalTrials.gov Identifier:
NCT00099281
First received: December 10, 2004
Last updated: February 27, 2007
Last verified: February 2007
History of Changes
  Purpose

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.

Condition Intervention Phase
Breast Cancer
Metastases
 Drug: YMB 1002
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study of DPPE Combined With Epirubicin and Cyclophosphamide vs Epirubicin and Cyclophosphamide Alone as First Line Treatment in Metastatic/Recurrent Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by YM BioSciences:

Primary Outcome Measures:
  • Overall survival

Secondary Outcome Measures:
  • Response rate
  • Progression-free survival
  • Toxicity
  • Neurocognitive function

Estimated Enrollment: 700
Study Start Date: May 2004
Estimated Study Completion Date: June 2006
Detailed Description:

Endpoints of the trial are as follows:

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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099281

Locations
United Kingdom
PharmOlam
London, United Kingdom
Sponsors and Collaborators
YM BioSciences
Investigators
Study Chair: Kathleen Pritchard, MD Sunnybrook Health Sciences Centre
  More Information

Additional Information:
Click here for more information on YM BioSciences  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00099281     History of Changes
Other Study ID Numbers: YMB1002 02
Study First Received: December 10, 2004
Last Updated: February 27, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by YM BioSciences:
Metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Cyclophosphamide
Epirubicin
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on May 16, 2013