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

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. Identifier: NCT00099281
Recruitment Status : Terminated
First Posted : December 10, 2004
Last Update Posted : February 28, 2007
Information provided by:
YM BioSciences

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

Condition or disease Intervention/treatment Phase
Breast Cancer Metastases Drug: YMB 1002 Phase 3

Detailed Description:

Endpoints of the trial are as follows:

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 700 participants
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
Study Start Date : May 2004
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Response rate
  2. Progression-free survival
  3. Toxicity
  4. Neurocognitive function

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00099281

United Kingdom
London, United Kingdom
Sponsors and Collaborators
YM BioSciences
Study Chair: Kathleen Pritchard, MD Sunnybrook Health Sciences Centre Identifier: NCT00099281     History of Changes
Other Study ID Numbers: YMB1002 02
First Posted: December 10, 2004    Key Record Dates
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
Breast Diseases
Skin Diseases
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