The purpose of this study is to compare the effect of Eflapegrastim on duration of neutropenia in patients with early-stage breast cancer when administered at varying intervals following Docetaxel and Cyclophosphamide administration.
This is a Phase 1, randomized, open label, actively-controlled study to evaluate the same day dosing of Eflapegrastim on duration of neutropenia when administered at varying intervals following Docetaxel and Cyclophosphamide (TC) chemotherapy in patients with early-stage breast cancer. The study will be conducted in two phases: Early Phase and Expansion Phase. 1. In the Early Phase, approximately 45 patients were enrolled and randomized in a 1:1:1 ratio to 3 dosing time schedule arms. Each cycle was of 21 days. Total 4 cycles were evaluated for this phase. On Day 1 of Cycle 1, patients received Docetaxel and Cyclophosphamide (TC) chemotherapy followed by administration of Eflapegrastim at 1 of 3-time schedules post-TC (30 minutes \[mins\], 3 hours or 5 hours). During Cycles 2-4, patients received Eflapegrastim 24 hours after TC administration (on Day 2). 2. In the Expansion Phase, additional 45 patients will be enrolled in Cycles 1-4, who will receive fixed dose of Eflapegrastim 30 mins after TC administration (on Day 1). Safety evaluations will be conducted once the first 3 patients (for Early Phase) and the first 6 patients (for Expansion Phase) have completed Cycle 1 to determine if it is safe for patients to continue in that particular treatment arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Administered in Cycle 1, 30 minutes after TC chemotherapy. Administered in Cycles 2-4, on day 2 of each cycle.
Administered in Cycle 1, 3 hours after TC chemotherapy. Administered in Cycles 2-4, on day 2 of each cycle.
Administered in Cycle 1, 5 hours after TC chemotherapy. Administered in Cycles 2-4, on day 2 of each cycle.
ACRC/ Arizona Clinical Research Center
Tucson, Arizona, United States
Yuma Regional Medical Center Cancer Center
Yuma, Arizona, United States
Pacific Cancer Medical Center
Anaheim, California, United States
City of Hope
Long Beach, California, United States
Time to Recovery of Absolute Neutrophil Count (ANC) From Nadir to ≥1.5×10^9/L in Cycle 1
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.
Time frame: Cycle 1 is 21 days
Duration of Grade 4 Neutropenia (DSN) in Cycle 1
DSN is defined as the number of days of severe neutropenia where the ANC\<0.5x10\^9/L from the first occurrence of an ANC below the threshold.
Time frame: Cycle 1 is 21 days
Proportion of Patients With Grade 4 Neutropenia in Cycle 1
Time frame: Cycle 1 is 21 days
Incidence of Grade 3 Febrile Neutropenia (FN) in Cycle 1
FN is defined as having an ANC\<1.0x10\^9/L and either a single temperature of \>38.3 degrees Celsius (101.0 Fahrenheit \[F\]) or a sustained temperature of \>38.0 degrees Celsius (100.4 F).
Time frame: Cycle 1 is 21 days
Incidence of Neutropenic Complications, Including Hospitalization due to Neutropenia, FN, and use of Anti-infectives During Cycle 1
Time frame: Cycle 1 is 21 days
Expansion Phase: Time to Recovery of ANC From Nadir to ≥1.5×10^9/L in Cycles 2-4
Time to ANC Recovery is defined as the time from chemotherapy administration until the patient's ANC increases to ≥1.5×10\^9/L after the expected nadir.
Time frame: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Expansion Phase: DSN in Cycles 2-4
DSN is defined as the number of days of severe neutropenia where the ANC \<0.5x10\^9/L from the first occurrence of an ANC below the threshold.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Administered in Cycles 1-4, 30 mins after TC chemotherapy.
75 mg/m\^2 IV infusion. Administered on Day 1 of each cycle.
600 mg/m\^2 IV infusion. Administered on Day 1 of each cycle.
BRCR Medical Center, Inc.
Plantation, Florida, United States
Bond & Steele Clinic, P.A.
Winter Haven, Florida, United States
SCL Health Research Institute, Inc.
Billings, Montana, United States
Mercy Health Youngstown
Youngstown, Ohio, United States
Time frame: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Expansion Phase: Proportion of Patients With Grade 4 Neutropenia in Cycles 2-4
Time frame: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Expansion Phase: Incidence of FN in Cycles 2-4
FN is defined as having an ANC\<1.0x10\^9/L and either a single temperature of \>38.3 degrees Celsius (101.0 F) or a sustained temperature of \>38.0 degrees Celsius (100.4 F).
Time frame: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Expansion Phase: Incidence of Neutropenic Complications, Including Hospitalization due to Neutropenia, FN, and use of Anti-infectives During Cycles 2-4
Time frame: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety
Time frame: Up to approximately 40 days after the last dose of study treatment or early study discontinuation (up to approximately 4 months)
Proportion of Patients Discontinuing Because of a TEAE
Time frame: Up to approximately 40 days after the last dose of study treatment or early study discontinuation (up to approximately 4 months)