Breast Cancer Clinical Trial
Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
Summary
The purpose of this study is to assess the effect of test doses of SPI-2012 on the duration of severe neutropenia (DSN) during Cycle 1 in participants with breast cancer who are candidates for adjuvant or neoadjuvant chemotherapy.
Full Description
This is an open label, multicenter, dose ranging study, sequentially enrolled by study dose, with a non-inferiority design to compare the effectiveness of SPI-2012 relative to a fixed dose of pegfilgrastim as a concurrent active control to each dose of SPI-2012 in participants with breast cancer. This study included four arms comprising three dose levels of SPI-2012 (Arm 1: 45 µg/kg, Arm 2: 135 µg/kg, Arm 3: 270 µg/kg) versus pegfilgrastim (Arm 4: 6 mg). The start of study is defined as the initiation of treatment with SPI-2012 or pegfilgrastim. The duration of treatment consists of a maximum of 4 cycles (21 days per cycle) beginning on Day 1 with chemotherapy administration and continue through Day 21, plus a 30-day follow-up period, unless any of the discontinuation criteria applies.
The target population are participants with breast cancer who are candidates for neoadjuvant or adjuvant treatment with Docetaxel + Cyclophosphamide (TC) chemotherapy. All participants who receive at least 1 dose of either SPI-2012 or pegfilgrastim were followed for safety through 30 days after their last dose of study treatment or until all treatment-related adverse events (AEs) have resolved or returned to baseline/Grade 1, whichever is longer, or until it is determined that the outcome will not change with further follow-up.
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
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There are 25 Locations for this study
Glendale Arizona, 85306, United States
Scottsdale Arizona, 85255, United States
Fresno California, 93720, United States
Highland California, 92346, United States
Los Angeles California, 92025, United States
Whittier California, 90603, United States
Hazard Kentucky, 41701, United States
Albany New York, 12206, United States
Setauket New York, 11733, United States
Corvallis Oregon, 97330, United States
Frankston Victoria, 3199, Australia
Brisbane , 7000, Australia
Kurralta Park , 5037, Australia
Perth , 6000, Australia
Wendouree , 3355, Australia
Batumi , 6000, Georgia
Tbilisi , 0186, Georgia
Budapest , 1062, Hungary
Budapest , 1122, Hungary
Budapest , 1146, Hungary
Debrecen , 4032, Hungary
NyÃregyháza , , Hungary
Zefat , 13100, Israel
GrudziÄ…dz , 86-30, Poland
Kraków , 31-50, Poland
Racibórz , 47-40, Poland
Warszawa , 02-10, Poland
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