Clinical Trials Logo
NCT number NCT03252431
Study type Interventional
Source Generon (Shanghai) Corporation Ltd.
Contact
Status Not yet recruiting
Phase Phase 3
Start date September 30, 2017
Completion date September 30, 2019

Clinical Trial 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.


Clinical Trial 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.


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Recruiting NCT03095352 - A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Antibody, in Combination With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease Phase 2
Recruiting NCT01472094 - Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults N/A
Recruiting NCT03284957 - Phase 1 / 2 Study of SAR439859 Single Agent and in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer Phase 1/Phase 2
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data N/A
Recruiting NCT01857193 - Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer Phase 1
Active, not recruiting NCT02139358 - Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer Phase 1/Phase 2
Terminated NCT01649258 - Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy N/A
Not yet recruiting NCT03289039 - Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer Phase 2
Recruiting NCT01992432 - Brain Functional MRI in Older Women With Breast Cancer (Brain fMRI-BC) N/A
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
Active, not recruiting NCT02371174 - Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan. N/A
Not yet recruiting NCT03273348 - Role of Oncoplastic Breast Surgery In Breast Cancer Treatement N/A
Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
Recruiting NCT03237572 - Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer Phase 1
Recruiting NCT02125019 - Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer N/A
Recruiting NCT02739425 - The Efficacy of Sentimag in Detection of Sentinel Node Biopsy N/A
Recruiting NCT02955394 - Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer Phase 2
Recruiting NCT02911155 - Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists N/A
Not yet recruiting NCT03159598 - Drain-Less Abdominally Based Breast Reconstruction Using Lysine-Derived Urethane Adhesive N/A
Not yet recruiting NCT03176888 - Health Benefits of HIT for Breast Cancer Patients N/A