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.

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.

Eligibility Criteria:
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 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

Exclusion Criteria:

* 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