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


Phase 3
16 Years
N/A
Not Enrolling
Female
Breast Cancer, Metastases

Thank you

Trial Information

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


Endpoints of the trial are as follows:

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Principal Investigator

Kathleen Pritchard, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sunnybrook Health Sciences Centre

Authority:

United States: Food and Drug Administration

Study ID:

YMB1002 02

NCT ID:

NCT00099281

Start Date:

May 2004

Completion Date:

June 2006

Related Keywords:

  • Breast Cancer
  • Metastases
  • Metastatic breast cancer
  • Breast Neoplasms
  • Neoplasm Metastasis

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