Clinical trials: Neutropenia in Breast Cancer
Chemotherapy-Induced Neutropenia, Myelosuppression
Efficacy and Safety Phase IIa Study of Myelo001 in Chemotherapy-Induced Neutropenia
Neutropenia is the most serious hematologic toxicity of cancer chemotherapy, often limiting the doses and density of chemotherapy that can be tolerated. The degree and duration of neutropenia determine the risk of infection.
- Conditions
- Chemotherapy-Induced Neutropenia, Myelosuppression, Breast Cancer
- Trial name
- MyeloConcept (NCT02692742)
- Testing
- Myelo001
- Where
- 23 sites in Germany
- Volunteers
- 137 people
- Sponsor
- Myelo Therapeutics GmbH
Chemotherapy-induced Neutropenia
Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).
- Trial name
- NCT02104830
- Testing
- Empegfilrastim 6 mg, Filgrastim, Empegfilrastim 7.5 mg
- Where
- 13 sites in Russia
- Volunteers
- 135 people
- Sponsor
- Biocad
Cancer-related Fatigue, Neutropenia, Malignant
PG2 Breast Cancer Evaluation in Adjuvant Medicine Study
Adjuvant chemotherapy usually is recommended after surgery for breast cancer patients who are at significant risk for disseminated disease. Chemotherapy has been demonstrated to reduce the risk of breast cancer recurrence.
- Trial name
- PG2 BEAM (NCT03314805)
- Testing
- Astragalus polysaccharides 500 mg, EC Chemotherapy
- Where
- 5 sites in Taiwan
- Volunteers
- 67 people
- Sponsor
- PhytoHealth Corporation
Chemotherapy Associated Neutropenia, Breast Cancer
Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim
The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
- Trial name
- PIONEER (NCT01519700)
- Testing
- EP2006, Filgrastim
- Where
- 26 sites in Czechia, Hungary and 4 more
- Volunteers
- 218 people
- Sponsor
- Sandoz
Breast Cancer
A Study of Cyclophosphamide/Methotrexate/5-Fluorouracil (CMF) With Pegfilgrastim in Subjects With Breast Cancer
The purpose of this study is to assess the relative dose intensity (RDI) of intravenous (IV) CMF on a Day 1 and 8 schedule given every 28 days with pegfilgrastim support in subjects with stage I-III breast cancer.
- Trial name
- NCT00124111
- Testing
- pegfilgrastim, cyclophosphamide, methotrexate
- Sponsor
- Amgen
Neutropenia, Breast Cancer
SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide
The purpose of this study is to compare the efficacy of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) as measured by the duration of severe neutropenia…
- Trial name
- NCT02953340
- Testing
- SPI-2012, Pegfilgrastim, Docetaxel
- Where
- 74 sites in United States, Canada and 4 more
- Volunteers
- 237 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Breast Cancer Female
Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients.
Accelerated AC regimen-Doxorubicin 60 mg/m2,Cyclophosphamide 600 mg/m2 on day 1 \& day 14 of each cycle along with G-CSF support for up to 4 cycles, followed by Paclitaxel 175 mg/m2 in the next 4 cycles is the standard clinical…
- Trial name
- NCT03381417
- Testing
- pegcyte, Neulastim
- Where
- Vietnam
- Volunteers
- 128 people
- Sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock Company
Febrile Neutropenia
Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer
To assess the safety and establish the dose to assess the pharmacokinetic activity following administration of EC-18 in patients with advanced breast cancer receiving low febrile neutropenia risk chemotherapy who are the…
- Trial name
- NCT03104595
- Testing
- EC-18
- Where
- 3 sites in South Korea
- Volunteers
- 28 people
- Sponsor
- Enzychem Lifesciences Corporation
Chemotherapy-induced Neutropenia
Plinabulin iv Solution in Prevention of TAC Induced Neutropenia
The primary purpose of this study is to compare the duration of severe neutropenia (DSN) in patients treated with: Docetaxel, doxorubicin, and cyclophosphamide (TAC) + pegfilgrastim versus Docetaxel, doxorubicin, and…
- Trial name
- NCT04227990
- Testing
- Plinabulin, Pegfilgrastim, Docetaxel, doxorubicin, and cyclophosphamide (TAC)
- Where
- 11 sites in China, Ukraine
- Volunteers
- 115 people
- Sponsor
- BeyondSpring Pharmaceuticals Inc.
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
Chemotherapy-induced Neutropenia
Randomized Phase 2, Dose-finding Efficacy, Safety Study of ANF-RHO™ Versus Neulasta® in Chemotherapy-Induced Neutropenia
Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing…
- Trial name
- NCT03559387
- Testing
- ANF-RHO™, Neulasta®
- Where
- 8 sites in France, Netherlands
- Volunteers
- 9 people
- Sponsor
- Prolong Pharmaceuticals
Neutropenia
A Phase II, Dose-finding Study of F-627 in Patients With Breast Cancer Receiving Myelotoxic Chemotherapy.
This was a randomized, open-label, active-controlled, dose-finding, phase II study to evaluate the efficacy and safety of 2 doses of F-627 compared to Filgrastim in women with breast cancer receiving myelotoxic chemotherapy.
- Trial name
- NCT02521441
- Testing
- F-627, Filgrastim
- Where
- China
- Volunteers
- 138 people
- Sponsor
- EVIVE Biotechnology
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
Breast Cancer
A Study to Learn About the Relationship Between Hepatic Impairment and 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 evaluate incidence of grade 4 neutropenia in patients who have hepatic impairment and use the study medicine Palbociclib.This study is seeking participants: - treated with the study medicine…
- Trial name
- NCT05912933
- Where
- United States
- Volunteers
- 1,342 people
- Sponsor
- Pfizer
Breast Cancer
PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy
The purpose of this study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy
- Trial name
- NCT02805153
- Testing
- PEG-rhG-CSF, rhG-CSF
- Volunteers
- 215 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Breast Cancer
Treatment for Elderly Patients With High Risk Breast Cancer
This open-label, multicenter study explored primary and secondary prophylaxis treatment with a single, fixed-dose, subcutaneous (SC) injection of pegfilgrastim in elderly subjects with high-risk breast cancer receiving…
- Trial name
- NCT00117910
- Testing
- pegfilgrastim
- Sponsor
- Amgen
Neutropenic Complications, Breast Neoplasms
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®
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.
- Conditions
- Neutropenic Complications, Breast Neoplasms, Chemotherapy-induced Neutropenia, Chemotherapeutic Toxicity
- Trial name
- PROTECT-1 (NCT01735175)
- Testing
- LA-EP2006, Neulasta®
- Where
- 41 sites in Brazil, India and 4 more
- Volunteers
- 316 people
- Sponsor
- Sandoz
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.
Breast Neoplasms, Chemotherapy-Induced Febrile Neutropenia
Efficacy and Safety Study With MYL-1401H and Neulasta
This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy.
- Trial name
- NCT02467868
- Testing
- MYL-1401H, Neulasta
- Where
- 36 sites in Bulgaria, Georgia and 4 more
- Volunteers
- 193 people
- Sponsor
- Mylan Inc.
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