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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04187898 | Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer | PHASE1 | COMPLETED | 59 | — | — | Mar 11, 2020 | Aug 16, 2024 | Sep 19, 2024 | 8 | United States |
Time to ANC Recovery is defined as the time from chemotherapy administration until the patient's ANC increases to ≥1.5×10\^9/liter (L) after the expected nadir.
| Arm | Type | Description |
|---|---|---|
| Early Phase: Eflapegrastim @ 30mins post TC | EXPERIMENTAL | Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg granulocyte colony-stimulating factor \[G-CSF\]). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 30 minutes from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days. |
| Early Phase: Eflapegrastim @ 3 hours post TC | EXPERIMENTAL | Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 3 hours from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days. |
| Early Phase: Eflapegrastim @ 5 hours post TC | EXPERIMENTAL | Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 5 hours from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days. |
| Expansion Phase: Eflapegrastim @ 30 mins post TC | EXPERIMENTAL | Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycles 1-4: Administered on the same day as TC chemotherapy, 30 minutes following the end of TC administration. Each cycle is 21 days. |
| Name | Type | Description |
|---|---|---|
| Eflapegrastim | BIOLOGICAL | Administered in Cycle 1, 30 minutes after TC chemotherapy. Administered in Cycles 2-4, on day 2 of each cycle. |
| Docetaxel | DRUG | 75 mg/m\^2 IV infusion. Administered on Day 1 of each cycle. |
| Cyclophosphamide | DRUG | 600 mg/m\^2 IV infusion. Administered on Day 1 of each cycle. |
Inclusion Criteria: * Willing and capable of giving written Informed Consent and able to adhere to study drug dosing time and blood draw schedules * New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer * Candidate to rec...