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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01126190 | Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel | PHASE3 | COMPLETED | 381 | — | — | Jun 30, 2010 | Feb 29, 2012 | Mar 28, 2023 | 59 | Bulgaria, Romania +3 |
Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count \[ANC\] \<0.5 x 10\^9/liter \[L\]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10\^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10\^9/L within the cycle.
Severe neutropenia was defined as Grade 4 neutropenia (ANC \<0.5 x 10\^9/L). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10\^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10\^9/L within the cycle. There was no planned statistical analysis for the open-label phase arm.
| Arm | Type | Description |
|---|---|---|
| Double-Blind Phase: Pegfilgrastim | ACTIVE_COMPARATOR | Participants will receive pegfilgrastim 6 milligrams (mg), administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/square meter (m\^2) and docetaxel 75 mg/m\^2 administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles. |
| Double-Blind Phase: Neugranin 40 mg | EXPERIMENTAL | Participants will receive neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles. |
| Open-Label Phase: Neugranin 40 mg | EXPERIMENTAL | Participants will receive neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles. |
| Name | Type | Description |
|---|---|---|
| Neugranin | BIOLOGICAL | Neugranin will be administered per dose and schedule specified in the arm description. |
| Pegfilgrastim | BIOLOGICAL | Pegfilgrastim will be administered per dose and schedule specified in the arm description. |
| Chemotherapy | DRUG | The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 in combination |
Inclusion Criteria: * Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel) Exclusion Criteria: * Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months)