SPI-2012 vs Pegfilgrastim in Management of Neutropenia in BReast Cancer Patients With Docetaxel and Cyclophosphamide

• Status: Completed
• Trial end date: 2019-07-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy of SPI-2012 with pegfilgrastim in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) to prevent and reduce Neutropenia that is associated with cancer chemotherapy.

• 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. (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.

• Known sensitivity to E. coli derived products.

• 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.