Phase 3 Real-world Effectiveness Of G-CSF In Pts with BC
This is a phase 3 multi-center randomized controlled experiment. In Phase 3, 222 individuals are expected to be enrolled.
The chemotherapy in this study will consist of docetaxel, doxorubicin, and cyclophosphamide (TAC). These are some of the most active and widely used chemotherapeutic medicines for treating patients with breast cancer. TAC chemotherapy, in particular, has been used as an adjuvant treatment for HER2 negative early breast cancer patients with node positive illness, as well as node negative breast cancer patients with a high risk of recurrence.
Plinabulin is a new small chemical being researched to treat chemotherapy-induced neutropenia. Plurabulin will be given in a single dosage per cycle by IV infusion on the same day as (about 1 hour after) chemotherapy (TAC). Plinabulin is being researched to see if it may be used instead of G-CSF, pegfilgrastim, to avoid chemotherapy-induced neutropenia.
This experiment will be double-blind, with around 222 breast cancer patients expected to participate. Patients are allocated to one of the treatment arms at random, with 111 patients in each arm, with the arm designation and planned intervention as follows:
TAC + pegfilgrastim (6.0 mg) + placebo matching plinabulin in arm 1.
TAC + pegfilgrastim (6.0 mg) + plinabulin (Arm 2) (40 mg).
TAC (or TC for Cycles 2–4) will be delivered IV on Day 1 every 21 days for Cycles 1–4. Patients will be given a single dose of plinabulin or placebo IV over 30 minutes (5 minutes) in a double-blind fashion, 30 minutes after the end of the TAC (or TC for Cycles 2 to 4). All patients will receive a single dose of pegfilgrastim on Day 2 of each cycle (24 hours after completing chemotherapy) (6.0 mg).
Long-term safety follow-up will be undertaken on all subjects approximately every 6 months up to 5 years through patient interactions via phone calls, mail, or electronic methods; or medical record reviews.