TriangleNCT03252431 · CITED IN SOURCE DOCUMENTS
Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2023-07-03
This is a randomized, multi-center, single dose, open-label and Neulasta controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with Stage I - III invasive breast cancer receiving chemotherapy treatment.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Duration in Days of Grade 4 Neutropenia in Chemotherapy Cycle 1
Duration in Days of Use of Intravenous Antibiotic
Duration in Days of Hospitalization
The Number of Participants With Grade 4 Neutropenia for Chemotherapy Cycle 1
The Number of Participants With Febrile Neutropenia Considering All Chemotherapy Cycles.
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
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: 1. Show evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial. 2. Females ≥18 years of age. 3. Diagnosed with Stage I-III breast cancer. 4. Subject is scheduled to undergo 4 cycles of neoadjuvant or adjuvant TC chemotherapy (docetaxel, cyclophosphamide, 75, 600 mg/m2, respectively). 5. ECOG Performance status of ≤2. 6. WBC count ≥4.0 × 109/L, hemoglobin ≥11.5 g/dL and a platelet count ≥150 × 109/L. 7. Demonstrate adequate renal, hepatic, and cardiac function (liver function tests \[alanine aminotransferase {ALT}, aspartate aminotransferase {AST}, alkaline phosphatase, and total bilirubin\]) should be less than 2.5x the upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN. 8. All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide is also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial. Exclusion Criteria: 1. Subject is \<18 years of age. 2. Disease progression has occurred while receiving a taxane regimen. 3. Subject has undergone radiation therapy within 4 weeks of enrollment. 4. Subject has undergone bone marrow or stem-cell transplantation. 5. Subject has a history of prior malignancy other than breast cancer that is NOT in remission. 6. Subjects that have used G-CSF or any other drug that may potentiate the release of neutrophils (i.e., lithium) within 6 weeks of the screening period are excluded. 7. Subject has had chemotherapy within 180 days of screening. 8. Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, electrocardiogram (ECG) test, or any other relevant test. 9. History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure. 10. Unwillingness to participate in the study. 11. Any underlying medical condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events. 12. Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment (if known), which ever is less. 13. Any condition, which can cause splenomegaly. 14. Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease. 15. ALT, AST, alkaline phosphatase, total bilirubin ≥2.5x ULN. 16. Subject with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C. 17. Women who are pregnant or breast-feeding. 18. Subject known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder. 19. Subject with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated. 20. Subjects with Sickle Cell disease 21. Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.
- intervention Names
- Drug: F-627
- label
- F-627
- type
- EXPERIMENTAL
- description
- 6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles
- intervention Names
- Drug: Neulasta
- label
- Neulasta
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- F-627
- description
- single dose pre-filled syringe
- name
- F-627
- type
- DRUG
- arm Group Labels
- Neulasta
- description
- single dose pre-filled syringe
- name
- Neulasta
- other Names
- pegfilgrastim
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- DOUBLE
- who Masked
- INVESTIGATOR
- OUTCOMES_ASSESSOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 393
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Duration in Days of Grade 4 Neutropenia in Chemotherapy Cycle 1
- time Frame
- The first of 4, 21-day chemotherapy cycles (average 3 weeks)
- secondary Outcomes
- description
- The duration of use of IV antibiotics was defined as the number of days in which IV antibiotics were administered
- measure
- Duration in Days of Use of Intravenous Antibiotic
- time Frame
- across all 4 chemotherapy cycles (average 84 days)
- description
- 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.
- measure
- Duration in Days of Hospitalization
- time Frame
- across all 4 chemotherapy cycles (average 84 days)
- description
- 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.
- measure
- 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)
- description
- The number of participants with febrile neutropenia, considering all chemotherapy cycles.
- measure
- The Number of Participants With Febrile Neutropenia Considering All Chemotherapy Cycles.
- time Frame
- across all 4 chemotherapy cycles (average 84 days)
- description
- The number of participants with use of IV antibiotics, considering all chemotherapy cycles.
- measure
- The Number of Participants With Use of IV Antibiotics Considering All Chemotherapy Cycles.
- time Frame
- across all 4 chemotherapy cycles (average 84 days)
- description
- The number of participants in hospitalization for febrile neutropenia or any infection, .
- measure
- 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)
Full study description
- brief Summary
- This is a randomized, multi-center, single dose, open-label and Neulasta controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with Stage I - III invasive breast cancer receiving chemotherapy treatment.
- detailed Description
- 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.
Source references
Source notices and limitations
Discovery and provenance
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- d patients compared to placebo-treated patients in cycle 1 (4.8% versus 25.6%, respectively, p=0.0016; 20.8% difference [95% CI: 1.8%, 38.8%]. Study GC-627-05 [NCT03252431] was a randomized, active-controlled study that compared RYZNEUTA to pegfilgrastim. Study GC-627-05 employed docetaxel 75 mg/m 2 and cyclophosphamide 600 mg/m
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Preserved source evidence · Not medical advice