Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
Neutropenia
About this trial
This is an interventional treatment trial for Neutropenia
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed breast cancer and candidate for adjuvant or neoadjuvant chemotherapy
- Candidate for docetaxel and cyclophosphamide chemotherapy
- Female or male at least 18 years of age
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Absolute neutrophil count (ANC) ≥ 1.5×109/L
- Platelet count ≥ 100 x 10^9/L
- Creatinine ≤ 1.5 x upper limit of normal (ULN)
- Total bilirubin ≤1.5 mg/dL(≤ 25.65 μmol/L).
- Aspartate aminotransferase per serum glutamic-oxaloacetic transaminase (AST/SGOT) and/or alanine aminotransferase per serum glutamic-pyruvic transaminase (ALT/SGPT) ≤ 2.5 x ULN
- Hemoglobin > 9 g/dL
- Alkaline phosphatase ≤ 1.5 x ULN
Exclusion Criteria:
- Known sensitivity to E. coli-derived products or known sensitivity to any of the products to be administered
- Known Human Immunodeficiency Virus (HIV) infection
- Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) diagnosis with detectable viral load or immunological evidence of chronic active disease
- Active infection or any serious underlying medical condition that would impair ability to receive protocol treatment
- Prior bone marrow or stem cell transplant
- Prolonged exposure to glucocorticosteroids and immunosuppressive agents
Sites / Locations
- Arizona Center for Cancer Care
- Desert Springs Cancer Care
- California Cancer Associates for Research and Excellence
- Beaver Medical Group
- California Cancer Associates for Research and Excellence
- Innovative Clinical Research Institute
- Kentucky Cancer Clinic
- New York Oncology Hematology, PC
- North Shore Hematology/Oncology Associates
- Good Samaritan Hospital, Corvallis
- Frankston Hospital
- Royal Hobart
- Ashford Cancer Center Research
- Breast Cancer Research Center, WA
- Ballarat Oncology & Haematology
- LTD " Cancer Center of Adjara Autonomic Republic"
- Ltd ' Medulla - Chemotherapy and Immunotherapy Clinic
- State Health Center
- National Institute of Oncology
- Uzsoki Hospital
- University Debrecen, Oncology Clinic
- Szabolcs - Szatmár - Bereg megyei Kórházak és Egyetemi Oktatókórház
- Ziv Medical Center
- Regionalny Szpital Specjalistyczny
- Szpital Uniwersytecki w Krakowie
- Dzienny Oddział Chemioterapii
- MTZ Clinical Research Sp. z o.o.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC)
Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC)
Arm 3: SPI-2012 270 µg/kg and Docetaxel + Cyclophosphamide (TC)
Arm 4: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)
Participants received SPI-2012 45 microgram/kilogram (µg/kg), subcutaneously (SC) once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 milligram/ square metre (mg/m^2) intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes.
Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes.
Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes.
Participants received Pegfilgrastim 6 milligram (mg), SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes.