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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00081510 | Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (P03480) | PHASE2 | COMPLETED | 110 | — | — | Dec 1, 2003 | May 1, 2009 | Apr 15, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| Lonafarnib plus Anastrozole | EXPERIMENTAL | Participants receive lonafarnib 200 mg orally (PO) twice per day (BID) beginning on Day 1 Cycle 1 and continuing until Progression of Disease, unacceptable toxicity, or other discontinuation criteria are met; and anastrozole 1 mg, PO, once per day (QD) for as long as the participant is receiving lonafarnib |
| Placebo plus Anastrozole | ACTIVE_COMPARATOR | Participants receive placebo to lonafarnib PO BID beginning on Day 1 Cycle 1 until Progression of Disease, unacceptable toxicity, or other discontinuation criteria are met; and anastrozole, 1mg PO QD for as long as the participant is receiving placebo |
| Name | Type | Description |
|---|---|---|
| Lonafarnib | DRUG | - |
| Placebo | DRUG | - |
| anastrozole | DRUG | - |
Inclusion Criteria: * Postmenopausal women who have histologically-confirmed breast cancer with the following characteristics: * estrogen and/or progesterone receptor positive, * locally advanced disease * distant metastatic disease, stage 4 * Subjects eligible for single-agent treatment wit...