SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide
Condition: Neutropenia; Breast Cancer
MeSH terms: Breast Neoplasms; Neutropenia
Intervention: SPI-2012; Pegfilgrastim; Docetaxel; Cyclophosphamide
Intervention description: Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle; Subcutaneous injection administered on Day 2 of each cycle.; 75mg/m^2 IV infusion administered on Day 1 of each cycle; 600mg/m^2 IV infusion administered on Day 1 of each cycle
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: 237.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neutropenia; Breast Cancer; Long-acting Granulocyte Colony Stimulating Factor; Early Stage Breast Cancer; Docetaxel + Cyclophosphamide (TC) chemotherapy

Summary:

      The purpose of this study is to compare the efficacy 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).
    

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 neo-adjuvant TC chemotherapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status <= 2

          -  Absolute neutrophil count (ANC) >=1.5×10^9/L

          -  Platelet count >=100×10^9/L

          -  Hemoglobin >9 g/dL

          -  Calculated creatinine clearance > 50 mL/min

          -  Total bilirubin <=1.5 mg/dL

          -  Aspartate aminotransferase (AST) / Serum glutamic oxaloacetic transaminase (SGOT) and
             Alanine aminotransferase (ALT)/Serum glutamic pyruvic transaminase (SGPT) <=2.5×ULN
             (upper limit of normal)

          -  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/metastatic breast cancer

          -  Known sensitivity to E. coli-derived products

          -  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 underlying medical condition that
             would impair ability to receive protocol treatment

          -  Prior bone marrow or stem cell transplant

          -  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• Radiation
             therapy within 30 days prior to enrollment

          -  Major surgery within 30 days prior to enrollment