Breast CancerPhase 2NCT02685111

Intermittent G-CSF in Patients With Breast Cancer Receiving Adjuvant Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)

A Phase 2 study testing Filgrastim and Peg-filgrastim in people with Breast Cancer and Neutropenia, run by Asan Medical Center at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

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 Cyclophosphamide (TAC) regimen Read more about this study

Who is it for?: Ages 19 to 70 years, women only
Conditions the study is for: Breast Cancer, Neutropenia, Febrile Neutropenia
What is being tested?: Filgrastim and Peg-filgrastim
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteSouth Korea
Study dates: Feb 2016to Dec 2017
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

The patients who underwent surgery for pathologically diagnosed early breast cancer (high risk stage II or stage III) or completely resected stage IV, and anticipated to undergo adjuvant chemotherapy with TAC regimen (docetaxel, doxorubicin, and cyclophosphamide)
The patients satisfying laboratory findings below before the enrollment of clinical trials: A. Absolute Neutrophil Count(ANC) ≥ 1,500/mm³; B. Platelet Count ≥ 100,000/mm³; C. Adequate renal functions (Cr < 1.5 X ULN); and D. Adequate liver function (Bilirubin < 1.5 X ULN, AST/ALT < 2.5 X ULN)
ECOG Performance status: 0-1
Cardiac ejection fraction ≥ 50% as measured by MUGA or 2D echocardiography without clinically significant abnormalities
Voluntarily participated in this study, and written informed consent of the patient

Who cannot join

Past history of immunotherapy or chemotherapy
Past history of autologous stem cell transplantation or bone marrow transplantation
The patient undergone radiation therapy within 4 weeks after written informed consent
Patient with any other concurrent malignancies or who are currently cured with past history within 5 years (excluding completely resected stage I early skin cancer)
Pregnant or lactating women, women of childbearing potential not employing adequate contraception
Other serious illness or medical conditions inadequate to chemotherapy: A. Unstable cardiac disease (i.e. congestive heart failure, arrhythmia, symptomatic coronary artery disease) despite treatment, myocardial infarction within 6 months prior to study entry; B. History of significant neurological or psychiatric disorders including dementia or seizures; Active uncontrolled infection (viral, bacterial or fungal infection); and D. Other serious medical illnesses

Show all 11Show fewer

Known hypersensitivity to any of the study drugs or its ingredients
Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
Past history of usage of granulocyte-colony stimulating factors
Patients with a known history of HIV (+) or HCV (+). However, HBV(+) patients who undergo primary prophylaxis are eligible.
Other serious illness or medical conditions determined by investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Asan Medical Center
Seoul, 138-746

Other trials in South Korea

About this study

Official title: Intermittent Every Other Days of 5 Shot-filgrastim Compared With Single Pegfilgrastim in Breast Cancer Patients Receiving Adjuvant Docetaxel, Doxorubicin, and Cyclophosphamide Chemotherapy (Intermittent G-CSF 105)

Read the detailed description

According to manufacturers' recommendations (Amgen: Neupogenᵀᴹ), filgrastim are to start 24 hrs after the last dose of chemotherapy and continue until absolute neutrophil count (ANC) has recovered to within the normal range (or for 14 days). However, for economic and practical reasons and/or patient's convenience, it has been common practice to initiate filgrastim at a later days of cycle and/or administer a shorter course of treatment. Data from several clinical studies have shown that 10-11 days' filgrastim treatment is required for optimal prophylaxis for febrile neutropenia (FN), and data from other cancers shows that suboptimal use of G-CSFs could deteriorate clinical outcomes. However, in two recent randomized study with breast cancer patients undergoing TAC chemotherapy, acceptable incidence (7-18%) of FN was shown with the consecutive 6 or 7-daily filgrastim schemes. Also, although there is theoretical concern that there can be wide fluctuations in the patient's ANC over time in alternate or intermittent filgrastim administration, because there was no difference in clinical outcomes between daily- or intermittent-dose filgrastim schedules in previous literatures, the intermittent every other day of 5 shot-filgrastim scheme would have clinical outcomes comparable with previous consecutive 6 or 7-daily filgrastim schemes in coverage of ANC nadir. Therefore, it can be justified to investigate the non-inferiority of intermittent every other days of 5 shot-filgrastim scheme compared with control arm using of pegfilgrastim on D2.

Conditions: Breast Cancer, Neutropenia, Febrile Neutropenia
Being tested: Filgrastim, Peg-filgrastim
Keywords: Breast cancer, Adjuvant, Docetaxel, Adriamycin, Cyclophosphamide, Neutropenia, Filgrastim, Pegfilgrastim
Medical subject headings: Breast Neoplasms, Neutropenia, Febrile Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FilgrastimDrug
Also called Grasinᵀᴹ pfs inj.
Filgrastim (Gracinᵀᴹ) is administered at the D3, D5, D7, D9, and D11 of each cycle. A dose of 5 μg/kg/day filgrastim is administered S.C. either as a bolus injection or as a continuous injection. Administer into the outer upper arm, abdomen (except within 2 inches of navel), front middle thigh, or the upper outer buttocks area.
Peg-filgrastimDrug
Also called Neulastaᵀᴹ pfs inj. 6mg/0.6ml
Pegfilgrastim (Neulastaᵀᴹ) is administered at the D2 of each cycle. A dose of 6mg once a cycle is administered S.C., 24 (± 2) hours after completion of chemotherapy.

Study groups in NCT02685111
Study group	Role	What they receive
A. Pegfilgrastim	Active comparator	D2 once a cycle pegfilgrastim arm Receives: Drug: Peg-filgrastim
B. Filgrastim	Experimental	Intermittent Every Other Days of 5 Shot (D3-11) filgrastim arm Receives: Drug: Filgrastim

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative incidence of febrile neutropenia
Measured at the completion of cycle 3
Measured: through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks

Secondary outcomes (6)

Incidence of febrile neutropenia at each cycle
Measured at the completion of each cycle 1, 2, and 3
Measured: At each cycle 1, 2, and 3 (each cycle is 21 days)
Rates of anti-microbial use
Measured at the completion of cycle 3
Measured: through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks
Duration of anti-microbial use
Measured at the completion of cycle 3
Measured: through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks
Cumulative dose of chemotherapeutic agents
Measured at the completion of cycle 3
Measured: through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks
Delay rate of next chemotherapy cycle due to inadequate neutrophil recovery
Measured at the completion of each cycle 1, 2, and 3
Measured: At each cycle 1, 2, and 3 (each cycle is 21 days)
Duration of delay of next chemotherapy cycle due to inadequate neutrophil recovery
Measured at the completion of each cycle 1, 2, and 3
Measured: At each cycle 1, 2, and 3 (each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016Dec 2017

First posted18 Feb 2016 (estimated)
Study startFeb 2016
Primary completionDec 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Asan Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02685111
Sponsor's protocol ID: AMC 2015-1143
Status last verified: Jul 2020
First submitted: 10 Feb 2016
Last updated: 31 Jul 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Scott SD, Chrischilles EA, Link BK, Delgado DJ, Fridman M, Stolshek BS. Days of prophylactic filgrastim use to reduce febrile neutropenia in patients with non-Hodgkin's lymphoma treated with chemotherapy. J Manag Care Pharm. 2003 Mar-Apr;9(2 Suppl):15-21. doi: 10.18553/jmcp.2003.9.s2.15.
PubMed 14613340
von Minckwitz G, Raab G, Caputo A, Schutte M, Hilfrich J, Blohmer JU, Gerber B, Costa SD, Merkle E, Eidtmann H, Lampe D, Jackisch C, du Bois A, Kaufmann M. Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the GEPARDUO study of the German Breast Group. J Clin Oncol. 2005 Apr 20;23(12):2676-85. doi: 10.1200/JCO.2005.05.078.
PubMed 15837982
Weycker D, Hackett J, Edelsberg JS, Oster G, Glass AG. Are shorter courses of filgrastim prophylaxis associated with increased risk of hospitalization? Ann Pharmacother. 2006 Mar;40(3):402-7. doi: 10.1345/aph.1G516. Epub 2006 Feb 21.
PubMed 16492793
Holmes FA, Jones SE, O'Shaughnessy J, Vukelja S, George T, Savin M, Richards D, Glaspy J, Meza L, Cohen G, Dhami M, Budman DR, Hackett J, Brassard M, Yang BB, Liang BC. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol. 2002 Jun;13(6):903-9. doi: 10.1093/annonc/mdf130.
PubMed 12123336
Green MD, Koelbl H, Baselga J, Galid A, Guillem V, Gascon P, Siena S, Lalisang RI, Samonigg H, Clemens MR, Zani V, Liang BC, Renwick J, Piccart MJ; International Pegfilgrastim 749 Study Group. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003 Jan;14(1):29-35. doi: 10.1093/annonc/mdg019.
PubMed 12488289
Koumakis G, Vassilomanolakis M, Barbounis V, Hatzichristou E, Demiri S, Plataniotis G, Pamouktsoglou F, Efremidis AP. Optimal timing (Preemptive versus supportive) of granulocyte colony-stimulating factor administration following high-dose cyclophosphamide. Oncology. 1999;56(1):28-35. doi: 10.1159/000011926.
PubMed 9885374
Martin M, Lluch A, Segui MA, Ruiz A, Ramos M, Adrover E, Rodriguez-Lescure A, Grosse R, Calvo L, Fernandez-Chacon C, Roset M, Anton A, Isla D, del Prado PM, Iglesias L, Zaluski J, Arcusa A, Lopez-Vega JM, Munoz M, Mel JR. Toxicity and health-related quality of life in breast cancer patients receiving adjuvant docetaxel, doxorubicin, cyclophosphamide (TAC) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): impact of adding primary prophylactic granulocyte-colony stimulating factor to the TAC regimen. Ann Oncol. 2006 Aug;17(8):1205-12. doi: 10.1093/annonc/mdl135. Epub 2006 Jun 9.
PubMed 16766587
von Minckwitz G, Kummel S, du Bois A, Eiermann W, Eidtmann H, Gerber B, Hilfrich J, Huober J, Costa SD, Jackisch C, Grasshoff ST, Vescia S, Skacel T, Loibl S, Mehta KM, Kaufmann M; German Breast Group. Pegfilgrastim +/- ciprofloxacin for primary prophylaxis with TAC (docetaxel/doxorubicin/cyclophosphamide) chemotherapy for breast cancer. Results from the GEPARTRIO study. Ann Oncol. 2008 Feb;19(2):292-8. doi: 10.1093/annonc/mdm438. Epub 2007 Sep 9.
PubMed 17846019
Papaldo P, Lopez M, Marolla P, Cortesi E, Antimi M, Terzoli E, Vici P, Barone C, Ferretti G, Di Cosimo S, Carlini P, Nistico C, Conti F, Di Lauro L, Botti C, Di Filippo F, Fabi A, Giannarelli D, Calabresi F. Impact of five prophylactic filgrastim schedules on hematologic toxicity in early breast cancer patients treated with epirubicin and cyclophosphamide. J Clin Oncol. 2005 Oct 1;23(28):6908-18. doi: 10.1200/JCO.2005.03.099. Epub 2005 Aug 29.
PubMed 16129844

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intermittent Every Other Days of 5 Shot-filgrastim Compared With Single Pegfilgrastim in Breast Cancer Patients Receiving Adjuvant Docetaxel, Doxorubicin, and Cyclophosphamide Chemotherapy (Intermittent G-CSF 105)
ClinicalTrials.gov ID: NCT02685111
Acronym / sponsor ID: AMC 2015-1143
Conditions: Breast Cancer, Neutropenia, Febrile Neutropenia
Keywords: Breast cancer, Adjuvant, Docetaxel, Adriamycin, Cyclophosphamide, Neutropenia, Filgrastim, Pegfilgrastim
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 22 participants (actual)
Lead sponsor: Asan Medical CenterUniversity, hospital or other
Collaborators: Kyowa Kirin Co., Ltd.
Study start: Feb 2016 (actual)
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 18 Feb 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A. Pegfilgrastim	Active comparator	Drug: Peg-filgrastimD2 once a cycle pegfilgrastim arm
B. Filgrastim	Experimental	Drug: FilgrastimIntermittent Every Other Days of 5 Shot (D3-11) filgrastim arm

Who may qualify

Ages: 19 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

The patients who underwent surgery for pathologically diagnosed early breast cancer (high risk stage II or stage III) or completely resected stage IV, and anticipated to undergo adjuvant chemotherapy with TAC regimen (docetaxel, doxorubicin, and cyclophosphamide)
The patients satisfying laboratory findings below before the enrollment of clinical trials: A. Absolute Neutrophil Count(ANC) ≥ 1,500/mm³; B. Platelet Count ≥ 100,000/mm³; C. Adequate renal functions (Cr < 1.5 X ULN); and D. Adequate liver function (Bilirubin < 1.5 X ULN, AST/ALT < 2.5 X ULN)
ECOG Performance status: 0-1
Cardiac ejection fraction ≥ 50% as measured by MUGA or 2D echocardiography without clinically significant abnormalities
Voluntarily participated in this study, and written informed consent of the patient

Key exclusion criteria (11 listed)

Past history of immunotherapy or chemotherapy
Past history of autologous stem cell transplantation or bone marrow transplantation
The patient undergone radiation therapy within 4 weeks after written informed consent
Patient with any other concurrent malignancies or who are currently cured with past history within 5 years (excluding completely resected stage I early skin cancer)
Pregnant or lactating women, women of childbearing potential not employing adequate contraception

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FilgrastimAlso: Grasinᵀᴹ pfs inj.Filgrastim (Gracinᵀᴹ) is administered at the D3, D5, D7, D9, and D11 of each cycle. A dose of 5 μg/kg/day filgrastim is administered S.C. either as a bolus injection or as a continuous injection. Administer into the outer upper arm, abdomen (except within 2 inches of navel), front middle thigh, or the upper outer buttocks area.	Drug	B. Filgrastim
Peg-filgrastimAlso: Neulastaᵀᴹ pfs inj. 6mg/0.6mlPegfilgrastim (Neulastaᵀᴹ) is administered at the D2 of each cycle. A dose of 6mg once a cycle is administered S.C., 24 (± 2) hours after completion of chemotherapy.	Drug	A. Pegfilgrastim

Primary outcome

Cumulative incidence of febrile neutropenia
Time frame: through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks
Measured at the completion of cycle 3

6 secondary outcomes

Incidence of febrile neutropenia at each cycle
Time frame: At each cycle 1, 2, and 3 (each cycle is 21 days)
Rates of anti-microbial use
Time frame: through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks
Duration of anti-microbial use
Time frame: through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks
Cumulative dose of chemotherapeutic agents
Time frame: through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks
Delay rate of next chemotherapy cycle due to inadequate neutrophil recovery
Time frame: At each cycle 1, 2, and 3 (each cycle is 21 days)
Duration of delay of next chemotherapy cycle due to inadequate neutrophil recovery
Time frame: At each cycle 1, 2, and 3 (each cycle is 21 days)

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
Background: PubMed 14613340Scott SD, Chrischilles EA, Link BK, Delgado DJ, Fridman M, Stolshek BS. Days of prophylactic filgrastim use to reduce febrile neutropenia in patients with non-Hodgkin's lymphoma treated with chemotherapy. J Manag Care Pharm. 2003 Mar-Apr;9(2 Suppl):15-21. doi: 10.18553/jmcp.2003.9.s2.15.
Background: PubMed 15837982von Minckwitz G, Raab G, Caputo A, Schutte M, Hilfrich J, Blohmer JU, Gerber B, Costa SD, Merkle E, Eidtmann H, Lampe D, Jackisch C, du Bois A, Kaufmann M. Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the GEPARDUO study of the German Breast Group. J Clin Oncol. 2005 Apr 20;23(12):2676-85. doi: 10.1200/JCO.2005.05.078.
Background: PubMed 16492793Weycker D, Hackett J, Edelsberg JS, Oster G, Glass AG. Are shorter courses of filgrastim prophylaxis associated with increased risk of hospitalization? Ann Pharmacother. 2006 Mar;40(3):402-7. doi: 10.1345/aph.1G516. Epub 2006 Feb 21.
Background: PubMed 12123336Holmes FA, Jones SE, O'Shaughnessy J, Vukelja S, George T, Savin M, Richards D, Glaspy J, Meza L, Cohen G, Dhami M, Budman DR, Hackett J, Brassard M, Yang BB, Liang BC. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol. 2002 Jun;13(6):903-9. doi: 10.1093/annonc/mdf130.
Background: PubMed 12488289Green MD, Koelbl H, Baselga J, Galid A, Guillem V, Gascon P, Siena S, Lalisang RI, Samonigg H, Clemens MR, Zani V, Liang BC, Renwick J, Piccart MJ; International Pegfilgrastim 749 Study Group. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003 Jan;14(1):29-35. doi: 10.1093/annonc/mdg019.
Background: PubMed 9885374Koumakis G, Vassilomanolakis M, Barbounis V, Hatzichristou E, Demiri S, Plataniotis G, Pamouktsoglou F, Efremidis AP. Optimal timing (Preemptive versus supportive) of granulocyte colony-stimulating factor administration following high-dose cyclophosphamide. Oncology. 1999;56(1):28-35. doi: 10.1159/000011926.
Background: PubMed 16766587Martin M, Lluch A, Segui MA, Ruiz A, Ramos M, Adrover E, Rodriguez-Lescure A, Grosse R, Calvo L, Fernandez-Chacon C, Roset M, Anton A, Isla D, del Prado PM, Iglesias L, Zaluski J, Arcusa A, Lopez-Vega JM, Munoz M, Mel JR. Toxicity and health-related quality of life in breast cancer patients receiving adjuvant docetaxel, doxorubicin, cyclophosphamide (TAC) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): impact of adding primary prophylactic granulocyte-colony stimulating factor to the TAC regimen. Ann Oncol. 2006 Aug;17(8):1205-12. doi: 10.1093/annonc/mdl135. Epub 2006 Jun 9.
Background: PubMed 17846019von Minckwitz G, Kummel S, du Bois A, Eiermann W, Eidtmann H, Gerber B, Hilfrich J, Huober J, Costa SD, Jackisch C, Grasshoff ST, Vescia S, Skacel T, Loibl S, Mehta KM, Kaufmann M; German Breast Group. Pegfilgrastim +/- ciprofloxacin for primary prophylaxis with TAC (docetaxel/doxorubicin/cyclophosphamide) chemotherapy for breast cancer. Results from the GEPARTRIO study. Ann Oncol. 2008 Feb;19(2):292-8. doi: 10.1093/annonc/mdm438. Epub 2007 Sep 9.
Background: PubMed 16129844Papaldo P, Lopez M, Marolla P, Cortesi E, Antimi M, Terzoli E, Vici P, Barone C, Ferretti G, Di Cosimo S, Carlini P, Nistico C, Conti F, Di Lauro L, Botti C, Di Filippo F, Fabi A, Giannarelli D, Calabresi F. Impact of five prophylactic filgrastim schedules on hematologic toxicity in early breast cancer patients treated with epirubicin and cyclophosphamide. J Clin Oncol. 2005 Oct 1;23(28):6908-18. doi: 10.1200/JCO.2005.03.099. Epub 2005 Aug 29.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sung-Bae Kim, Ph.D. principal investigator

Department of Oncology, Asan Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Filgrastim and Peg-filgrastim in people with Breast Cancer and Neutropenia, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative incidence of febrile neutropenia (time frame: through the completion of cycle 1-3 (each cycle is 21 days), an average of 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02685111, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.