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

• Sponsor: YM BioSciences (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00099281
• Collaborator: (none)
• Enrollment: 700
• Location: 1
• Duration (Months): 25
• Patients Per Site Per Month: 28

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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 1, 2004
• Study Completion Date: Jun 1, 2006

Outcome Measures

Primary Outcome Measures

1. Overall survival []

Secondary Outcome Measures

1. Response rate []

2. Progression-free survival []

3. Toxicity []

4. Neurocognitive function []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PharmOlam	London		United Kingdom

Sponsors and Collaborators

• YM BioSciences

Investigators

• Study Chair: Kathleen Pritchard, MD, Sunnybrook Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00099281
• Other Study ID Numbers: YMB1002 02
• First Posted: Dec 10, 2004
• Last Update Posted: Feb 28, 2007
• Last Verified: Feb 1, 2007

• Keywords provided by , ,: Metastatic breast cancer
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Feb 28, 2007