Clinical trials: Neutropenia in Breast Cancer
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
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
Breast Neoplasms, Fever
A Prospective, Randomized, Phase III Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Chemotherapy With GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor) Versus PIXY 321 in Advanced Breast Cancer
This is a prospective, randomized Phase III trial of FLAC chemotherapy with GM-CSF versus PIXY321 in advanced breast cancer. The primary endpoints of this study will be the duration of thrombocytopenia and the time to recovery of…
- Conditions
- Breast Neoplasms, Fever, Hematologic Diseases, Neutropenia
- Trial name
- NCT00001338
- Testing
- FLAC chemotherapy with GM-CSF
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- National Cancer Institute (NCI)
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
Neutropenia
Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
The purpose of this study is to assess the effect of test doses of SPI-2012 on the duration of severe neutropenia (DSN) during Cycle 1 in participants with breast cancer who are candidates for adjuvant or neoadjuvant chemotherapy.
- Trial name
- NCT01724866
- Testing
- SPI-2012, Pegfilgrastim, Docetaxel
- Where
- 27 sites in United States, Australia and 4 more
- Volunteers
- 148 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
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
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
Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or…
- Trial name
- NCT00002866
- Testing
- filgrastim, docetaxel, epirubicin hydrochloride
- Where
- 6 sites in Canada
- Volunteers
- 50 people
- Sponsor
- NCIC Clinical Trials Group
Breast Cancer, Neutropenia
Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for Chemotherapy Induced Severe Neutropenia
The overall purpose of this study is to assess the dose response, efficacy, and safety of three different dose levels of AVI 014 (granulocyte colony-stimulating factor [G-CSF]) in breast cancer patients at high (>20%) risk for…
- Trial name
- NCT00497809
- Testing
- AVI-014 versus Filgrastim
- Where
- 31 sites in United States, India
- Volunteers
- 189 people
- Sponsor
- AviGenics
Cancer
Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients
RATIONALE: Liposomal amphotericin B may be effective in controlling fever and granulocytopenia. It is not yet known which regimen of liposomal amphotericin B is more effective in treating cancer patients who have these…
- Trial name
- NCT00003938
- Testing
- liposomal amphotericin B
- Where
- 24 sites in Belgium, Czechia and 13 more
- Volunteers
- 115 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Neutropenia
Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy
After resection of lymph node positive breast cancer, the injection duration and timing of Granulocyte-colony stimulating factor (G-CSF) could affect the neutropenia with TAC (Taxotere, Adriamycin, cyclophosphamide) chemotherapy.
- Trial name
- NCT01571518
- Testing
- late leukostim, early leukostim
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Hyuk moon Kim
Prevention of Chemotherapy-induced Myelosuppression
A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer
This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb) receiving neoadjuvant or adjuvant chemotherapy with…
- Trial name
- NCT05622058
- Testing
- ALRN-6924, TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2)
- Where
- 14 sites in United States, Bosnia and Herzegovina and 2 more
- Volunteers
- 6 people
- Sponsor
- Aileron Therapeutics, Inc.
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
Adult Acute Lymphoblastic Leukemia, Adult Acute Myeloid Leukemia
Prolonged or Standard Infusion of Cefepime Hydrochloride in Treating Patients With Febrile Neutropenia
This randomized pilot clinical trial studies how well giving prolonged infusion compared to standard infusion of cefepime hydrochloride works in treating patients with febrile neutropenia.
- Conditions
- Adult Acute Lymphoblastic Leukemia, Adult Acute Myeloid Leukemia, Adult Burkitt Lymphoma, Adult Diffuse Large Cell Lymphoma
- Trial name
- NCT01484015
- Testing
- cefepime hydrochloride
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Wake Forest University Health Sciences
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.
Breast Cancer
Pegfilgrastim-gema Compared to Pegfilgrastim-roche for Prevention of Induced Neutropenia in Breast Cancer Patients.
This is a randomized, multicentre, Phase 3 study. Patients will be randomly assigned to the Study drug or its comparator. The study will be blinded for the staff members in charge of the endpoint assessment.
- Trial name
- NCT03404752
- Testing
- Peg-Filgrastim
- Where
- Argentina
- Volunteers
- 120 people
- Sponsor
- Gema Biotech S.A.
Breast Cancer, Neutropenia
Intermittent G-CSF in Patients With Breast Cancer Receiving Adjuvant Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)
To compare the efficacy and safety of Day 2 (D2) once a cycle pegfilgrastim with Intermittent Every Other Days of 5 Shot (D3-11) filgrastim in early breast cancer patients treated with adjuvant Docetaxel, Doxorubicin, and…
- Conditions
- Breast Cancer, Neutropenia, Febrile Neutropenia
- Trial name
- NCT02685111
- Testing
- Filgrastim, Peg-filgrastim
- Where
- South Korea
- Volunteers
- 22 people
- Sponsor
- Asan Medical Center
Breast Cancer, Lung Cancer
Descriptive Analysis of G-CSF Use in Patients With Breast Cancer, Lung Cancer, or Lymphoma Treated
Purpose: With the existing recombinant human granulocyte colony-stimulating factors (G-CSFs) patents expiring and the FDA approval of new biosimilar and innovator biologics, patients being treated with Grade III and IV…
- Trial name
- NCT02921191
- Testing
- filgrastim, TBO-filgrastim or pegfilgrastim
- Volunteers
- 57,725 people
- Sponsor
- Biologics & Biosimilars Collective Intelligence Consortium
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
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