SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
Condition: Neutropenia; Breast Cancer
MeSH terms: Breast Neoplasms; Neutropenia
Intervention: SPI-2012; Pegfilgrastim; Docetaxel; Cyclophosphamide
Intervention description: Single-use syringes for subcutaneous injection, administered on Day 2 of each cycle; Single-dose subcutaneous injection administered on Day 2 of each cycle; Standard therapy; Standard therapy
Intervention MeSH terms: Cyclophosphamide; Docetaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 406.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neutropenia; Breast Cancer; Long-acting Myeloid Growth Factor; Early Stage Breast Cancer; Docetaxel + Cyclophosphamide (TC) chemotherapy

Summary:

      The purpose of this study was to compare the efficacy of a single dose of SPI-2012 versus
      pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and
      cyclophosphamide (TC), as measured by the duration of severe neutropenia (DSN) in Cycle 1.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as
             operable Stage I to Stage IIIA breast cancer

          -  Candidate for adjuvant or neoadjuvant TC chemotherapy

          -  Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2

          -  Absolute neutrophil count (ANC) ≥ 1.5×10^9/L

          -  Platelet count ≥ 100×10^9/L

          -  Hemoglobin > 9 g/dL

          -  Creatinine clearance > 50 mL/min

          -  Total bilirubin ≤ 1.5 mg/dL

          -  Aspartate Aminotransferase per Serum Glutamic-Oxaloacetic Transaminase (AST/SGOT) and
             Alanine Aminotransferase per Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) ≤ 2.5×
             Upper Limit of Normal (ULN).

          -  Alkaline phosphatase ≤ 2.0×ULN

        Key Exclusion Criteria:

          -  Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of
             the cervix) or life-threatening disease

          -  Locally recurrent or metastatic breast cancer

          -  Known sensitivity to E. coli -derived products or to any products to be administered
             during dosing

          -  Concurrent adjuvant cancer therapy

          -  Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical
             development within 12 months prior to the administration of study drug

          -  Active infection, receiving anti-infectives, or any serious underlying medical
             condition that would impair ability to receive protocol treatment

          -  Prior bone marrow or stem cell transplant

          -  Use of 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

          -  Radiation therapy within 30 days prior to enrollment

          -  Major surgery within 30 days prior to enrollment