RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (ADVANCE)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (TC) (ADVANCE)|
- Duration of severe neutropenia (DSN) in Cycle 1 [ Time Frame: Up to 21 days ]DSN is defined as the number of days of severe neutropenia (ANC <0.5×10^9/L) from the first occurrence of an ANC below the threshold.
- Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 [ Time Frame: Up to 21 days ]
- Depth of ANC Nadir, defined as the patient's lowest ANC in Cycle 1 [ Time Frame: Up to 21 days ]
- Incidence of Febrile Neutropenia (FN) in patients during Cycle 1 [ Time Frame: Up to 21 days ]Febrile neutropenia (FN) will be evaluated through daily temperature monitoring to assess for fever and frequent CBCs to assess for neutropenia.
|Actual Study Start Date:||December 2015|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle.
Active Comparator: Pegfilgrastim
Single-dose subcutaneous injection administered on Day 2 of each cycle.
Other Name: Neulasta®
This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 (a long acting myeloid growth factor) with pegfilgrastim (Neulasta [NDC 55513-190-01] manufactured by Amgen) in breast cancer patients treated with TC chemotherapy.
Approximately 400 patients will be enrolled and randomized in a 1:1 ratio to 2 treatment arms.
Each cycle will be 21 days. Only 4 cycles will be evaluated for this study. On Day 1 of each cycle, patients will receive TC chemotherapy. On Day 2 of each cycle, patients will receive study drug (SPI-2012 or pegfilgrastim).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02643420
|United States, Tennessee|
|The West Clinic|
|Germantown, Tennessee, United States, 38138|
|Study Director:||Jose L Martinez, MD||Spectrum Pharmaceuticals, Inc|