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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02953340 | SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide | PHASE3 | COMPLETED | 237 | — | — | May 10, 2017 | May 6, 2019 | Mar 2, 2022 | 74 | United States, Canada +4 |
| NCT02643420 | SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE) | PHASE3 | COMPLETED | 406 | — | — | Jan 19, 2016 | Oct 31, 2018 | Mar 2, 2022 | 81 | United States, Canada +1 |
| NCT01724866 | Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer | PHASE2 | COMPLETED | 148 | — | — | Mar 25, 2013 | Aug 12, 2014 | Apr 15, 2022 | 27 | United States, Australia +4 |
DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \[ANC\] \<0.5×10\^9 per liter \[L\]) from the first occurrence of ANC below the threshold.
| Arm | Type | Description |
|---|---|---|
| (Arm 1): SPI-2012 and TC | EXPERIMENTAL | At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 milligrams (mg)/0.6 milliliter (mL), \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] subcutaneously (SC) approximately 24-26 hours after receiving intravenous (IV) infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment. |
| (Arm 2): Pegfilgrastim and TC | EXPERIMENTAL | At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment. |
| Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received SPI-2012 13.2 milligram (mg)/0.6 milliliter (mL) (3.6 mg Granulocyte Colony-Stimulating Factor \[G-CSF\]) fixed-dose subcutaneous (SC) injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 intravenous (IV) infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. |
| Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. |
| Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received SPI-2012 45 microgram/kilogram (µg/kg), subcutaneously (SC) once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 milligram/ square metre (mg/m\^2) intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes. |
| Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes. |
| Arm 3: SPI-2012 270 µg/kg and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes. |
| Arm 4: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received Pegfilgrastim 6 milligram (mg), SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes. |
| Name | Type | Description |
|---|---|---|
| SPI-2012 | DRUG | Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle |
| Pegfilgrastim | DRUG | Subcutaneous injection administered on Day 2 of each cycle. |
| Docetaxel | DRUG | 75mg/m\^2 IV infusion administered on Day 1 of each cycle |
| Cyclophosphamide | DRUG | 600mg/m\^2 IV infusion administered on Day 1 of each cycle |
Key Inclusion Criteria: * New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer * Candidate for adjuvant or neo-adjuvant TC chemotherapy * Eastern Cooperative Oncology Group (ECOG) performance status \<= 2 * Absolute neut...