Clinical trials: Neutropenia in Breast Cancer
Breast Cancer
Study on Efficacy and Safety of CBLB612 for Neutropenia Prophylaxis
Double blind, randomized, placebo-controlled, multicenter pilot study on efficacy and safety of CBLB612 following single administration for neutropenia prophylaxis in breast cancer patients receiving doxorubicin and…
- Trial name
- NCT02778763
- Testing
- CBLB612
- Volunteers
- 23 people
- Sponsor
- BioLab 612 LLC
Breast Cancer, Neutropenia
Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
This is a randomized open label dose finding study to evaluate the efficacy and safety of F-627 on women with Stage I-IV breast cancer receiving chemotherapy treatment.
- Trial name
- NCT01648322
- Testing
- F-627, Neulasta® (pegfilgrastim)
- Where
- United States
- Volunteers
- 232 people
- Sponsor
- EVIVE Biotechnology
Breast Cancer, Non-Small Cell Lung Cancer
A Study of Neutropenia and Anemia Management in Patients With Solid Tumors Receiving Myelotoxic Chemotherapy
The primary objective was to describe the incidence of febrile neutropenia based on granulocyte-colony stimulating factor (G-CSF) use (primary, secondary, treatment, or no usage) in patients receiving myelotoxic chemotherapy.
- Conditions
- Breast Cancer, Non-Small Cell Lung Cancer, Ovarian Cancer, Small Cell Lung Cancer
- Trial name
- NCT00883181
- Volunteers
- 1,370 people
- Sponsor
- Amgen
Chemotherapy-induced Neutropenia, Breast Cancer
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim
The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
- Trial name
- PROTECT2 (NCT01516736)
- Testing
- LA-EP2006, Neulasta®
- Where
- 53 sites in United States, Argentina and 6 more
- Volunteers
- 308 people
- Sponsor
- Sandoz
Neutropenia
A Pharmacokinetics/Dynamics Ib Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
This study was a phase Ib study of the safety and pharmacokinetics/pharmacodynamics of F-627 once per cycle as prophylaxis therapy to chemotherapy in women with breast cancer.
- Trial name
- NCT02522234
- Testing
- F-627 240 μg/kg, F-627 320 μg/kg
- Where
- China
- Volunteers
- 15 people
- Sponsor
- EVIVE Biotechnology
Breast Cancer, Fever
Same Day Dosing of Pegfilgrastim in Breast Cancer Patients Undergoing Chemotherapy (TAC)
The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.
- Conditions
- Breast Cancer, Fever, Neutropenia
- Trial name
- NCT00115414
- Testing
- pegfilgrastim, docetaxel, doxorubicin
- Sponsor
- Amgen
Neutropenia, Breast Cancer
Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer
The purpose of this study is to compare the effect of Eflapegrastim on duration of neutropenia in patients with early-stage breast cancer when administered at varying intervals following Docetaxel and Cyclophosphamide…
- Trial name
- NCT04187898
- Testing
- Eflapegrastim, Docetaxel, Cyclophosphamide
- Where
- 8 sites in United States
- Volunteers
- 59 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Chemotherapy-Induced Neutropenia, Breast Cancer
Evaluation of Maxy-G34 in Breast Cancer Patients Treated With TAC (Docetaxel, Adriamycin, Cyclophosphamide) Chemotherapy
This is an investigation of the safety and efficacy of Maxy-G34 in breast cancer patients treated with TAC chemotherapy. Maxy-G34 will be given as a single injection during each cycle of chemotherapy, for a planned total of six…
- Trial name
- NCT00501332
- Testing
- Maxy-G34
- Where
- 15 sites in Poland, Romania and 2 more
- Volunteers
- 30 people
- Sponsor
- Maxygen Holdings Ltd.
Chemotherapy-induced Neutropenia
Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.
- Trial name
- NEUGR-003 (NCT01126190)
- Testing
- Neugranin, Pegfilgrastim, Chemotherapy
- Where
- 59 sites in Bulgaria, Romania and 3 more
- Volunteers
- 381 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Chemotherapy-induced Febrile Neutropenia
Prospective Observational Study of Febrile Neutropenia (FN) and Pegfilgrastim Primary Prophylaxis in Breast Cancer and Non-Hodgkin's Lymphoma Patients Receiving High (>20%) FN-risk Chemotherapy
To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis.
- Trial name
- NCT02178475
- Where
- 74 sites in Austria, Belgium and 7 more
- Volunteers
- 943 people
- Sponsor
- Amgen
Breast Cancer, Neutropenia
Study to Compare the Efficacy and Safety of F-627 and GRAN®
A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Trial to Compare the Efficacy and Safety of Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein (F-627) and Recombinant Human Granulocyte…
- Trial name
- NCT04174599
- Testing
- F-627, GRAN®
- Where
- China
- Volunteers
- 242 people
- Sponsor
- EVIVE Biotechnology
Neutropenia, Chemotherapy-Induced Febrile, Breast Neoplasm Female
Study Evaluating PEG-G-CSF Injectionin Preventing Neutropenia After Chemotherapy
To evaluate the efficacy, safety, and immunogenicity of PEG-G-CSF Injection (Kexing Biopharmaceutical Co., Ltd.) for the prevention of neutropenia after chemotherapy, using the PEG-G-CSF Injection ( Neulasta®, Amgen Europe B.V.)…
- Trial name
- NCT06711523
- Testing
- PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.), PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.)
- Where
- China
- Volunteers
- 250 people
- Sponsor
- Kexing Biopharm Co., Ltd.
Breast Cancer, Neutropenia
Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
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.
- Trial name
- NCT03252431
- Testing
- F-627, Neulasta
- Where
- United States
- Volunteers
- 393 people
- Sponsor
- EVIVE Biotechnology
Chemotherapy-induced Neutropenia
Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia
The primary purpose of this study is to compare the percentage of patients with Duration of Severe Neutropenia (DSN) =0 in patients treated with: Docetaxel, doxorubicin, and cyclophosphamide (TAC) + pegfilgrastim versus…
- Trial name
- NCT03294577
- Testing
- Pegfilgrastim, Plinabulin, Docetaxel, doxorubicin, and cyclophosphamide (TAC)
- Where
- 20 sites in China, Ukraine
- Volunteers
- 221 people
- Sponsor
- BeyondSpring Pharmaceuticals Inc.
Breast Cancer, Neutropenia
A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF in Breast Cancer Patients Receiving Chemotherapy
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy.
- Conditions
- Breast Cancer, Neutropenia, Febrile Neutropenia
- Trial name
- NCT02119715
- Testing
- Pegylated rhG-CSF 100μg/kg, Pegylated rhG-CSF:150 μg/kg, rhG-CSF 5 μg/kg/day
- Where
- China
- Volunteers
- 182 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Neutropenia in Breast Cancer
A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer
This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.
- Trial name
- NCT01079676
- Testing
- Filgrastim (Eurofarma), Filgrastim (Granulokine, Amgen)
- Where
- 6 sites in Brazil
- Volunteers
- 220 people
- Sponsor
- Eurofarma Laboratorios S.A.
Neutropenia, Breast Cancer
SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
The purpose of this study was to compare the efficacy of a single dose of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the duration of…
- Trial name
- ADVANCE (NCT02643420)
- Testing
- SPI-2012, Pegfilgrastim, Docetaxel
- Where
- 81 sites in United States, Canada and 1 more
- Volunteers
- 406 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Breast Cancer
A Study to Learn About the Dangers Linked to Myelosuppression (Decreased Bone Marrow Function) in Breast Cancer Patients Treated With the Study Medicine Palbociclib (Pal Bow Sai Klib)
The purpose of this study is to explore risk factors for grade 4 neutropenia in users of the study medicine Palbociclib for the potential treatment of Palbociclib.
- Trial name
- NCT05709158
- Where
- United States
- Volunteers
- 4,184 people
- Sponsor
- Pfizer
Breast Cancer
Nanogen Pegfilgrastim (Pegcyte) PK/PD Clinical Study in Breast Cancer Patients
Breast cancer patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will be enrolled in this study. Eligible patients receive single SC injection of pegcyte or neulastim 24 hours after administration of…
- Trial name
- NCT03376503
- Testing
- Pegfilgrastim
- Where
- Vietnam
- Volunteers
- 24 people
- Sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock Company
Breast Cancer
A Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients
A study to compare the efficacy, safety and immunogenicity of Leucostim® to those of Neupogen® in patients with breast cancer intended to be treated with TAC regimen as a myelosuppressive chemotherapy.
- Trial name
- NCT03343145
- Testing
- Leucostim 5µg/kg/day, Neupogen 5µg/kg/day
- Where
- Indonesia
- Volunteers
- 143 people
- Sponsor
- Dong-A ST Co., Ltd.