A Prospective Randomised, Open, Multicentre, Phase III Study to Assess Different Durations of Anastrozole Therapy After 2 to 3 Years Tamoxifen as Adjuvant Therapy in Postmenopausal Women With Breast Cancer.
18 Years
N/A
Female
Breast Cancer
Trial Information
A Prospective Randomised, Open, Multicentre, Phase III Study to Assess Different Durations of Anastrozole Therapy After 2 to 3 Years Tamoxifen as Adjuvant Therapy in Postmenopausal Women With Breast Cancer.
Inclusion Criteria:
- postmenopausal patients with hormone receptor positive breast cancer who have already
received 2 to 3 years of adjuvant tamoxifen, and who never had signs of loco-regional
recurrences or distant metastasis
Exclusion Criteria:
- Previous hormonal therapy as adjuvant breast cancer treatment besides tamoxifen.
- Previous history of invasive breast cancer within the last 10 years, other then the
breast cancer that is currently treated with tamoxifen
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:
To assess the disease free survival (DFS) with 6 years of adjuvant anastrozole compared with 3 years of adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2 to 3 years of adjuvant tamoxifen
Outcome Time Frame:
Assessed after 3 years and 6 years
Safety Issue:
No
Principal Investigator
AstraZeneca Netherlands Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
D5392NL003
NCT ID:
NCT00301457
Start Date:
June 2006
Completion Date:
August 2015
Related Keywords:
- Breast Cancer
- Hormone Sensitive Primary Breast Cancer
- Adjuvant Treatment
- Aromatase Inhibitor
- Breast Neoplasms
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