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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00083304 | Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer | PHASE3 | COMPLETED | 368 | — | — | Feb 1, 2004 | Jun 1, 2007 | May 10, 2013 | 94 | United States, Argentina +13 |
| Arm | Type | Description |
|---|---|---|
| Efaproxiral + WBRT + Supplemental Oxygen | EXPERIMENTAL | - |
| WBRT + Supplemental Oxygen | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Efaproxiral | DRUG | 75 mg/kg, administered over 30 minutes via a central venous access device (CVAD). Administered 30 minutes prior to the start of whole brain radiation therapy (WBRT) on each WBRT treatment day for 10 days. |
| Whole Brain Radiation Therapy (WBRT) | RADIATION | 3.0 Gy per day for 10 days (30.0 Gy total) of WBRT. |
| Supplemental Oxygen | OTHER | 4 L/minute by nasal cannula. Administered at least 35 minutes prior to WBRT, during WBRT and until 15 minutes after completion of WBRT on all WBRT treatment days. |
Inclusion Criteria: * Adult women with brain metastases from breast cancer * Minimum KPS of 70 Exclusion Criteria: * Previous treatment for brain metastases, including brain surgery and any form of radiation to the brain