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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00412412 | CNF2024 (BIIB021) HER2- (QD) HER2+ (BIW w/Herceptin) PK/PD Study | PHASE1 | COMPLETED | 34 | — | — | Dec 1, 2007 | Apr 1, 2011 | Jun 8, 2012 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | Patients with HER2- Breast Cancer |
| B | EXPERIMENTAL | Patients with HER2+ Breast Cancer |
| Name | Type | Description |
|---|---|---|
| CNF2024 | DRUG | Oral doses of CNF2024 as specified in the protocol. |
| CNF2024 + trastuzumab | DRUG | Oral doses of CNF2024 as specified in the protocol Intravenous doses of trastuzumab as specified in the package insert. |
Inclusion Criteria (Group A): * Age ≥18 years at the time of informed consent. * Male and female subjects with confirmed HER2 adenocarcinoma of the breast with advanced disease (advanced disease will be defined as metastatic disease or locally advanced disease that is surgically unresectable and co...