Trial Information
A Partially-blind Phase III Randomised Trial of Fulvestrant (Faslodex) With or Without Concomitant Anastrozole (Arimidex) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-steroidal Aromatase Inhibitors
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the breast.
- Metastatic disease must be measurable or evaluable
- Relapsed or progressed during prior treatment with single-agent NSAI, meeting either
of the following criteria:
- NSAI given as adjuvant therapy that lasted ≥ 12 months OR
- Achieved an objective CR, PR, or SD that that lasted ≥ 6 months after prior 1st-line
- Female postmenopausal patients
Exclusion Criteria:
- Hormone receptor status1. ER -ve and PgR NK2. ER-ve and PgR -ve3. ER NK
- Prescribed Tamoxifen for metastatic disease
- Rapidly progressive visceral disease
- Patients with malignancies within the last 5 years.
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:
Progression-free survival
Outcome Time Frame:
every 3 months during treatment and, at time of discontinuation from treatment
Safety Issue:
No
Principal Investigator
Young-Huck Im
Investigator Role:
Principal Investigator
Investigator Affiliation:
Professor(Samsung Medical Center)
Authority:
Korea: Food and Drug Administration
Study ID:
9238UK/0005
NCT ID:
NCT00944918
Start Date:
December 2008
Completion Date:
June 2011
Related Keywords:
- Progression-free Survival
- Breast Cancer
- Breast Neoplasms