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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01492101 | The BEACON Study (Breast Cancer Outcomes With NKTR-102) | PHASE3 | COMPLETED | 852 | — | — | Dec 1, 2011 | Jun 1, 2016 | Jun 1, 2021 | 153 | United States, Belgium +9 |
Duration of OS was defined as the time from the date of randomisation to the date of death due to any cause. Subjects were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. OS was determined using the ITT population which included all subjects randomized into 1 of the 2 treatment arms. Subjects who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Subjects who did not have any follow-up since the date of randomization were censored at the date of randomization.
| Arm | Type | Description |
|---|---|---|
| NKTR-102 | EXPERIMENTAL | - |
| Physician's Treatment of Choice | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| NKTR-102 | DRUG | 145 mg/m2 NKTR-102 will be delivered q21day as a 90-minute intravenous (IV) infusion on day 1 of each treatment cycle. |
| Treatment of Physician's Choice (TPC) | DRUG | One of the following Treatment of Physician Choice will be administered per standard of care: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel |
Inclusion Criteria (major highlights): * Patient is an adult female with histologically or cytologically confirmed carcinoma of the breast for whom single-agent cytotoxic chemotherapy is indicated * Patient can have either measurable or non-measurable disease by RECIST. * Patient has received prior...