SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Breast CANCEr Patients With Docetaxel and Cyclophosphamide

• Status: Completed
• Trial end date: 2018-11-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy of a single dose of SPI-2012 with pegfilgrastim (Neulasta [NDC 55513-190-01] manufactured by Amgen) in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the Duration of Severe Neutropenia (DSN) in Cycle 1.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Pharmaceuticals, Inc
• Treatments: Cyclophosphamide; Docetaxel

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 to receive adjuvant or neo-adjuvant TC chemotherapy.

• ECOG ≤2.

• 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

• AST/SGOT and ALT/SGPT ≤2.5×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.

• Known sensitivity to E. coli derived products or known sensitivity to any of the products to be administered during dosing

• Concurrent adjuvant cancer therapy

• Locally recurrent/metastatic

• 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 or any serious underlying medical condition, which would impair the ability of the patient 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.

• Prior radiation therapy within 30 days prior to enrollment.

• Major surgery within 30 days prior to enrollment.