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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00099281
First Posted: December 10, 2004
Last Update Posted: February 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
YM BioSciences
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00099281     History of Changes
Other Study ID Numbers: YMB1002 02
First Submitted: December 10, 2004
First Posted: December 10, 2004
Last Update Posted: February 28, 2007
Last Verified: February 2007

Keywords provided by YM BioSciences:
Metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors