Trial Information
A Randomised, Double Blind Trial Comparing Arimidex Alone With Nolvadex Alone With Arimidex and Nolvadex in Combination, as Adjuvant Treatment in Post-Menopausal Women With Breast Cancer
Inclusion Criteria:
- Patients with histologically proven operable invasive breast cancer
- Patients who have completed all primary surgery and chemotherapy (if given), and are
candidates to receive hormonal adjuvant therapy
- Women defined as post-menopausal
Exclusion Criteria:
- Patients in whom there is any clinical evidence of metastatic disease
- Patients who, for whatever reason (e.g. confusion, infirmity, alcoholism), are
unlikely to comply with trial requirements
- Patients whose chemotherapy was started more than 8 weeks (ie 56 days) after
completion of primary surgery or whose chemotherapy was completed more than 8 weeks
(ie 56 days) before starting randomised treatment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Time to recurrence of breast cancer
Outcome Time Frame:
Earliest of local or distant recurrence, new primary breast cancer, or death
Safety Issue:
No
Authority:
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study ID:
1033IL/0029
NCT ID:
NCT00849030
Start Date:
July 1996
Completion Date:
April 2010
Related Keywords:
- Breast Cancer
- Breast Neoplasms