Breast Cancer Clinical Trial
Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer
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.
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).
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.
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 receive adjuvant or neoadjuvant TC chemotherapy
Age must be at least 18 years for the Early Phase, and between 18 to ≤55 years for the Expansion Phase
ANC ≥1.5×10^9/liter (L).
Platelet count ≥100×10^9/liter (L).
Hemoglobin >10 grams per deciliter (g/dL).
Calculated creatinine clearance >50 milliliter per minute (mL/min).
Total bilirubin ≤1.5 milligrams per deciliter (mg/dL).
Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤2.5×upper limit of normal (ULN).
Alkaline phosphatase ≤2.0×ULN.
Eastern Cooperative Oncology Group (ECOG) ≤2
Willing to practice 2 forms of contraceptives (1 must be a barrier method), from study entry through 30 days after last dose of study drug/ early discontinuation
Negative urine pregnancy test within 30 days before randomization
Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease
Known sensitivity to Escherichia coli (E. coli) derived products
Concurrent adjuvant cancer therapy other than the trial-specified therapies
Locally recurrent/metastatic breast cancer
Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 3 months prior to the administration of study drug
Receiving anti-infectives, has an underlying medical condition or other serious illness that would impair the ability to receive protocol-specified treatment
Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study
Prior bone marrow or stem cell transplant
Prior radiation therapy within 30 days prior to enrollment
Major surgery within 30 days prior to enrollment
Pregnant or breastfeeding
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There are 8 Locations for this study
Tucson Arizona, 85715, United States
Yuma Arizona, 85364, United States
Anaheim California, 92801, United States
Long Beach California, 90813, United States
Plantation Florida, 33322, United States
Winter Haven Florida, 33881, United States
Billings Montana, 59102, United States
Youngstown Ohio, 44501, United States
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