Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01602380 | A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer. | PHASE3 | COMPLETED | 462 | — | — | Oct 17, 2012 | Jan 16, 2026 | Feb 27, 2026 | 118 | United States, Argentina +18 |
PFS was defined as the time from randomisation until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), surgery or radiotherapy to manage worsening of disease or death by any cause (in the absence of progression). Outcome measure is reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.
| Arm | Type | Description |
|---|---|---|
| faslodex+placebo | EXPERIMENTAL | Blinded: Fulvestrant 500mg intramuscular injection (2x250mg) plus dummy Anastrozole tablets |
| arimidex +placebo | ACTIVE_COMPARATOR | Blinded: Anastrozole 1mg tablets plus dummy Fulvestrant intramuscular injection (2x0mg) |
| Name | Type | Description |
|---|---|---|
| faslodex 500mg | DRUG | 2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter |
| arimidex 1mg | DRUG | oral tablet 1 daily |
| faslodex dummy | DRUG | 2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter |
| arimidex dummy | DRUG | oral tablet 1 daily |
Inclusion Criteria: * Histological confirmation of breast cancer in post menopausal women (age \>=60). Positive hormone receptor status (ER +ve and/or PgR +ve) of primary or metastatic tumour tissue based on local laboratory assessment. * EITHER locally advanced disease (1 line of chemotherapy allo...