Conditions: Breast Cancer Neutropenia
Keywords: Breast Cancer Taxotere Chemotherapy Neulasta efficacy and safety single cycle doses of F-627 pegfilgrastim
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 232
Healthy volunteers: no

Brief summary:
This is a randomized open label dose finding study to evaluate the efficacy and safety of F-627 on women with Stage I-IV breast cancer receiving chemotherapy treatment.

Detailed description:
This is a randomized, multi-center, dose finding, open label, positive controlled Phase II study of the efficacy and safety of once-per-cycle of F-627 compared with Neulasta® (pegfilgrastim) in women with breast cancer who are receiving myelotoxic chemotherapy (TC: docetaxel + cyclophosphamide or TAC: docetaxel + doxorubicin + cyclophosphamide).

The primary objective of this study is to evaluate the efficacy and safety of various single cycle doses of F-627 as compared with the standard dosing of Neulasta® (pegfilgrastim) in breast cancer patients experiencing myelotoxic chemotherapy. Myelotoxicity in this study will be defined by the duration of moderate neutropenia; the number of days in which the patient has had an absolute neutrophil count (ANC) \< 1.0 × 10\^9/L during the first cycle of their chemotherapy treatment (each chemotherapy cycle is expected to last 21 days). This, by definition, includes grade 3 (moderate) and grade 4 (severe) neutropenia. Doses of F-627 to be tested for subjects receiving TC chemotherapy are 80 µg/kg/dose, 240 µg/kg/dose, and 320 µg/kg/dose. For subjects receiving TAC chemotherapy, only 240 µg/kg/dose and 320 µg/kg/dose are to be tested.

Arms:
arm 1: This dose of F-627 given only to subjects that are to have TC chemotherapy. arm 2: This dose of F-627 given to subjects receiving TC or TAC chemotherapy. arm 3: This dose of F-627 given to subjects receiving TC or TAC chemotherapy. arm 4: Given to subjects receiving TC or TAC chemotherapy.

Interventions: intervention 1: F-627 intervention 2: Neulasta® (pegfilgrastim)
Intervention descriptions: intervention 1: subcutaneous injection given 1 per chemotherapy. intervention 2: Single dose injection given once per chemotherapy cycle.

Protocol document: