Clinical Trial: NCT01602380
A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-02-27 |
Study Overview
Brief Summary
The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.
Official Title
A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.
Conditions
Hormone Receptor Positive Breast Cancer
Intervention / Treatment
- Drug: faslodex 500mg
- Drug: arimidex 1mg
- Drug: faslodex dummy
- Drug: arimidex dummy
Other Study ID Numbers
- D699BC00001
- 2011-006326-24
Start Date (Actual)
2012-10-17
Primary Completion Date (Actual)
2016-04-11
Study Completion Date (Actual)
2026-01-16
Enrollment (Actual)
462
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-02-27 |
Study Overview
Brief Summary
The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.
Official Title
A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.
Conditions
Hormone Receptor Positive Breast Cancer
Intervention / Treatment
- Drug: faslodex 500mg
- Drug: arimidex 1mg
- Drug: faslodex dummy
- Drug: arimidex dummy
Other Study ID Numbers
- D699BC00001
- 2011-006326-24
Start Date (Actual)
2012-10-17
Primary Completion Date (Actual)
2016-04-11
Study Completion Date (Actual)
2026-01-16
Enrollment (Actual)
462
Study Type
Interventional
Phase
Phase 3