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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00232661 | PROACT - Pre-Operative Arimidex Compared To Tamoxifen | PHASE3 | COMPLETED | 452 | — | — | Aug 1, 2000 | Dec 1, 2007 | Feb 3, 2010 | 79 | United States, Belgium +8 |
| NCT00570323 | Arimidex With or Without Faslodex In Postmenopausal Women With HR Positive Breast Cancer | PHASE2 | COMPLETED | 72 | — | — | Dec 1, 2007 | Dec 5, 2018 | Jul 28, 2020 | 1 | United States |
The primary endpoint is change in Ki-67 levels from baseline (pre) to day 28 (post) biopsy samples. Ki-67 levels were log-transformed to achieve approximately normally distributed data. The differences in these log-transformed values between post vs. pre biopsy samples were calculated. This difference represents the log of the ratio of post vs. pre Ki-67 levels in the original scale.
| Arm | Type | Description |
|---|---|---|
| ARM A / Arimidex with Faslodex | ACTIVE_COMPARATOR | Arimidex with Faslodex in postmenopausal women |
| ARM B Arimidex without Faslodex | ACTIVE_COMPARATOR | Arimidex without Faslodex in postmenopausal women. |
| Name | Type | Description |
|---|---|---|
| ARIMIDEX (anastrazole) | DRUG | - |
| NOLVADEX (tamoxifen) | DRUG | - |
| Arimidex | DRUG | Aromatase inhibitors |
| Faslodex | DRUG | Hormone Receptor |
Inclusion Criteria: * Operable or potentially operable breast cancer * Invasive breast cancer proven to be hormone-sensitive (ER+/PR+) * Patients who might benefit from endocrine treatment prior to surgery * Postmenopausal * Signed written informed consent Exclusion Criteria: * Inoperable breast ...