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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00837265 | Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel | PHASE2 | COMPLETED | 334 | — | — | Aug 21, 2008 | Jun 26, 2009 | Apr 3, 2024 | - | — |
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.
| Arm | Type | Description |
|---|---|---|
| Pilot Phase: Balugrastim Low Dose | EXPERIMENTAL | Participants will receive balugrastim low dose 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). |
| Pilot Phase: Balugrastim Medium Dose | EXPERIMENTAL | Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| Pilot Phase: Balugrastim High Dose | EXPERIMENTAL | Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| Pilot Phase: Pegfilgrastim | ACTIVE_COMPARATOR | Participants will receive pegfilgrastim 6 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). |
| Main Phase: Balugrastim Medium Dose | EXPERIMENTAL | Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| Main Phase: Balugrastim High Dose | EXPERIMENTAL | Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| Main Phase: Pegfilgrastim | ACTIVE_COMPARATOR | Participants will receive pegfilgrastim 6 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). |
| Name | Type | Description |
|---|---|---|
| Balugrastim | BIOLOGICAL | Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description. |
| Pegfilgrastim | DRUG | Pegfilgrastim will be administered per dose and schedule specified in the arm description. |
| Chemotherapy Regimen | DRUG | The chemotherapy regimen consisting of doxorubicin 60 mg/square meter (m\^2) and docetaxel 75 mg/m\^2 will be administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles. |
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).