At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 122 enrolled
Drug / intervention
F-627 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
In Brief
A Phase 3 clinical trial evaluating F-627 and Placebo for Breast Cancer and Neutropenia. Completed, enrolled 122 participants across 1 site.
Detailed Summary
This is a randomized, double-blind and placebo controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with stage II-IV breast cancer receiving chemotherapy treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Neutropenia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartAug 2016
First PostedAug 2016
Primary CompletionDec 2017
TodayJul 2026
First PostedAug 19, 2016
Enrollment StartAug 1, 2016
Primary CompletionDec 20, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.9 years ago
Interventions
F-627drug
F-627 subcutaneous injection on Day 2 of TA chemotherapy cycles. TA chemotherapy treatments are part of standard-of-care and not the study
Placebodrug
Placebo subcutaneous injection on Day 2 of the first TA chemotherapy cycle. TA chemotherapy treatments are part of standard-of-care and not the study.