A Prospective, Randomized, Open, Multicentre Phase III-study to Assess the Efficacy of Secondary Adjuvant Endocrine Anastrozole Therapy for 2 Further Yrs vs 5 Further Yrs in Patients With HR +ve Breast Cancer After 5-yr Primary Adjuvant Endocrine Therapy
N/A
80 Years
Female
Breast Cancer
Trial Information
A Prospective, Randomized, Open, Multicentre Phase III-study to Assess the Efficacy of Secondary Adjuvant Endocrine Anastrozole Therapy for 2 Further Yrs vs 5 Further Yrs in Patients With HR +ve Breast Cancer After 5-yr Primary Adjuvant Endocrine Therapy
Inclusion Criteria:
- No disease recurrence at time of randomization,
- Patients with breast cancer after surgery,
- 5 years (+/- 12 months) of prior endocrine therapy
Exclusion Criteria:
- Premenopausal patients,
- Unknown or negative receptor status,
- Secondary malignant tumor
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Assessment of the effect in terms of DFS of 2 further years of anastrozole treatment vs further 5 years of adjuvant anastrozole treatment, following 5 years of adjuvant endocrine treatment
Outcome Time Frame:
throughout study (approx 15 years)
Safety Issue:
No
Principal Investigator
AstraZeneca Austria Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Austria: Federal Office for Safety in Health Care
Study ID:
D5392L00016
NCT ID:
NCT00295620
Start Date:
March 2004
Completion Date:
January 2019
Related Keywords:
- Breast Cancer
- Hormone receptor positive breast cancer
- Breast Neoplasms
Name | Location |
|---|
