A Randomised Phase II Study Comparing Anastrozole and Fulvestrant to Anastrozole for Adjuvant Treatment of Postmenopausal Patients With Early Breast Cancer and Disseminated Tumour Cells in Bone Marrow
N/A
N/A
Female
Breast Cancer
Trial Information
A Randomised Phase II Study Comparing Anastrozole and Fulvestrant to Anastrozole for Adjuvant Treatment of Postmenopausal Patients With Early Breast Cancer and Disseminated Tumour Cells in Bone Marrow
Inclusion Criteria:
- Postmenopausal women with hormone receptor-positive early breast cancer and a
positive Disseminated Tumour Cell immunocytochemical result from bone marrow
aspiration prior to randomisation
Exclusion Criteria:
- Inflammatory and/or metastatic breast cancer.
- Current or previous malignancy within previous 5 years (other than Breast cancer or
adequately treated non-melanoma skin cancer or in-situ cervical cancer).
- History of bleeding diathesis.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)
Outcome Description:
Number of patients event-free
Outcome Time Frame:
12 month period following randomisation
Safety Issue:
No
Principal Investigator
Breast Cancer Established Brands Team Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Austria: Federal Ministry for Health and Women
Study ID:
D6990C00001
NCT ID:
NCT00357110
Start Date:
April 2006
Completion Date:
October 2008
Related Keywords:
- Breast Cancer
- Breast neoplasms
- breast cancer
- early breast cancer
- oncology
- cancer
- breast cancer micrometastasis
- fulvestrant
- Breast Neoplasms
Name | Location |
|---|
