Clinical trials: Neutropenia in Breast Cancer
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)
Breast Cancer Metastatic
Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Negative Breast Cancer
Prevention of Sacituzumab Govitecan-related Neutropenia in Patients with metastatic Triple Nagative Breast Cancer who have received at least one, and no more than two, prior standard of care chemotherapy regimens
- Trial name
- NCT06616987
- Testing
- Sacituzumab Govitecan with pegfilgrastim
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Yeon Hee Park
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
Metastatic Breast Cancer
Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer
Neutropenia is a common complication from dalpiciclib. Mecapegfilgramtim (code name HHPG-19K), a long-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF), has been developed.
- Trial name
- NCT05463601
- Testing
- Mecapegfilgrastim, dalpiciclib, exemestane, fulvestrant, letrozole, tamoxifen
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
Mammary Cancer, Lymphoma
The Efficacy and Safety of PEG-rhG-CSF in Neutropenia After Chemotherapy
The purpose of the trail is to evaluate the efficacy and safety of PEG-rhG-CSF in primary prophylaxis and secondary prophylaxis of neutropenia after chemotherapy.
- Conditions
- Mammary Cancer, Lymphoma, Bone Tumour, Gynecological Tumors
- Trial name
- NCT02905916
- Testing
- PEG-rhG-CSF
- Where
- China
- Volunteers
- 217 people
- Sponsor
- Peking University
Breast Cancer, Neutropenia
Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer
RATIONALE: Colony-stimulating factors, such as filgrastim or pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of…
- Trial name
- NCT00030758
- Testing
- filgrastim, pegfilgrastim
- Where
- 32 sites in United Kingdom
- Volunteers
- 816 people
- Sponsor
- Anglo Celtic Cooperative Oncology Group
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
Breast Cancer, Bone Marrow Suppression
A Randomized, Self-controlled Post-marketing Clinical Study on the Comparison of Shengbai Oral Liquid and Leucogen Tablets in the Treatment of Moderate Neutropenia Caused by Anti-tumor Drugs in Breast Cancer Patients
The subjects were randomly assigned to Group A or Group B in a 1:1 ratio, stratified by early/late stage. Group A: In the first cycle, they took Shengbai Oral Liquid (40 ml, three times a day), and in the second cycle, they took…
- Trial name
- NCT07578064
- Testing
- Group A, Group B
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Hongxia Wang
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
Breast Cancer, Chemotherapy
A Pilot Study to Evaluate the Safety and Activities of EW02 in Reducing Neutropenia Caused by Chemotherapy
Study Hypothesis: EW02 is a polysaccharide-enriched crude extract from black soybean (BS). BS has been used extensively by the Chinese as food or traditional Chinese medicine for hundreds of years.
- Conditions
- Breast Cancer, Chemotherapy, Neutropenia
- Trial name
- NCT00555516
- Testing
- EW02
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- Tri-Service General Hospital (TSGH)
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