Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03252431|
Recruitment Status : Completed
First Posted : August 17, 2017
Results First Posted : May 7, 2021
Last Update Posted : May 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Neutropenia||Drug: F-627 Drug: Neulasta||Phase 3|
This is a Phase III, global, two arm, open label clinical study will randomize approximately 400 female subjects (approximately 200 per arm) with Stage I - III invasive breast cancer who are to receive neoadjuvant or adjuvant myelotoxic TC chemotherapy treatment (docetaxel + cyclophosphamide, 75 and 600 mg/m2, respectively). Subjects in this study will be those who are scheduled to undergo at least four 21-day cycles of chemotherapy treatment. Subjects may be scheduled for more than 4 cycles of chemotherapy; however, study participation will be limited to a subject's first 4 cycles.
The primary objective of this study will be to evaluate the efficacy of F-627 given as a single fixed dose (20 mg) pre-filled syringe as compared to Neulasta® standard dosing (6 mg) in the first chemotherapy cycle. The primary endpoint will be the duration of grade 4 (severe) neutropenia - the number of days in which the patient has had an absolute neutrophil count (ANC <0.5 x 10^9/L) observed in chemotherapy cycle 1.
Approximately 24 hours after chemotherapy completion in each cycle (Day 2 of the cycle), subjects will receive one of the following treatments:
Arm 1: F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.
Arm 2: 6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles Randomization will occur in an equal ratio (1:1) using a central randomization system (IWRS) on Day 1 of the study, the day of chemotherapy administration for the first chemotherapy cycle.
This study is open-label, however, study drug injections are to be administered separately by qualified study personnel to allow study investigators to remain blinded and perform study assessments without knowledge of treatment assignment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||393 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||A Phase III, Randomized, Multi-Centre, Open-Label, Fixed Dose, Neulasta® Active-Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy|
|Actual Study Start Date :||April 12, 2018|
|Actual Primary Completion Date :||September 25, 2019|
|Actual Study Completion Date :||March 5, 2020|
F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.
single dose pre-filled syringe
Active Comparator: Neulasta
6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles
single dose pre-filled syringe
Other Name: pegfilgrastim
- Duration in Days of Grade 4 Neutropenia in Chemotherapy Cycle 1 [ Time Frame: The first of 4, 21-day chemotherapy cycles (average 3 weeks) ]Eligible subjects were randomized in a 1:1 ratio. Subjects were dosed with either the F 627 20 mg/dose PFS or Neulasta® 6 mg/dose as the study drug in each chemotherapy cycle. Subjects remained in their assigned treatment arm throughout the study. Subjects were dosed subcutaneously (SC) 24 to 28 hours after receiving TC chemotherapy (75 mg/m2 docetaxel + 600 mg/m2 cyclophosphamide) on Day 2 of each chemotherapy cycle that the subject underwent (up to 4 cycles). Grade 4 (severe) neutropenia was defined as ANC <0.5 × 109/L within the first 12 days of chemotherapy.
- Duration in Days of Use of Intravenous Antibiotic [ Time Frame: across all 4 chemotherapy cycles (average 84 days) ]The duration of use of IV antibiotics was defined as the number of days in which IV antibiotics were administered
- Duration in Days of Hospitalization [ Time Frame: across all 4 chemotherapy cycles (average 84 days) ]The duration in days of patients been hospitalized for febrile neutropenia (FN) or any infection. Febrile neutropenia is defined as a single oral temperature of ≥38.3°C (101°F) or a temperature of >38.0°C (100.4°F) sustained for >1 hour and ANC <0.5 x 10^9/L on the same day.
- The Number of Participants With Grade 4 Neutropenia for Chemotherapy Cycle 1 [ Time Frame: The first of 4, 21-day chemotherapy cycles (average 3 weeks) ]The number of participants with grade 4 neutropenia for chemotherapy cycle 1. Grade 4 (severe) neutropenia was defined as ANC <0.5 × 109/L within the first 12 days of chemotherapy.
- The Number of Participants With Febrile Neutropenia Considering All Chemotherapy Cycles. [ Time Frame: across all 4 chemotherapy cycles (average 84 days) ]The number of participants with febrile neutropenia, considering all chemotherapy cycles.
- The Number of Participants With Use of IV Antibiotics Considering All Chemotherapy Cycles. [ Time Frame: across all 4 chemotherapy cycles (average 84 days) ]The number of participants with use of IV antibiotics, considering all chemotherapy cycles.
- The Number of Participants in Hospitalization for Febrile Neutropenia or Any Infection Considering All Chemotherapy Cycles [ Time Frame: across all 4 chemotherapy cycles (average 84 days) ]The number of participants in hospitalization for febrile neutropenia or any infection, .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252431
|United States, California|
|University of California Los Angeles (UCLA) - Jonsson Comprehensive Cancer Center (JCCC)|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||John Glaspy, MD||University of California at Los Angeles|