Clinical trials: Neutropenia in Breast Cancer
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, Breast Cancer
Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up to 4 cycles of Epirubicin and Cyclophosphamide.
- Trial name
- NCT02527746
- Testing
- F-627, EC regimen
- Volunteers
- 18 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
Febrile Neutropenia, Stage 0 Breast Cancer
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
This randomized clinical trial studies prophylactic colony stimulating factor management in patients with breast, colorectal or non-small cell lung cancer receiving chemotherapy and with risk of developing febrile neutropenia.
- Conditions
- Febrile Neutropenia, Stage 0 Breast Cancer, Stage 0 Colorectal Cancer, Stage 0 Non-Small Cell Lung Cancer
- Trial name
- TrACER (NCT02728596)
- Testing
- Preventive Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Where
- 160 sites in United States, Puerto Rico
- Volunteers
- 3,665 people
- Sponsor
- SWOG Cancer Research Network
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
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, Neutropenia
Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
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.
- Trial name
- NCT02872103
- Testing
- F-627
- Where
- United States
- Volunteers
- 122 people
- Sponsor
- EVIVE Biotechnology
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
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
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
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
Chemotherapy-induced Febrile Neutropenia
Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.
This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy.
- Trial name
- NCT01813721
- Where
- 90 sites in Australia, Austria and 9 more
- Volunteers
- 1,007 people
- Sponsor
- Amgen
Chemotherapy-induced Neutropenia
Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day.
- Trial name
- NCT01569087
- Testing
- empegfilrastim, filgrastim
- Where
- 5 sites in Russia
- Volunteers
- 60 people
- Sponsor
- Biocad
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
Febrile Neutropenia, Cancer
Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor
This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for…
- Conditions
- Febrile Neutropenia, Cancer, Breast Cancer, Ovarian Cancer
- Trial name
- Monitor-GCSF (NCT01459653)
- Where
- 117 sites in Austria, Belgium and 10 more
- Volunteers
- 1,496 people
- Sponsor
- Sandoz
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