Breast NeoplasmsPhase 4NEUTHREENCT05949333
Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy
A Phase 4 study testing Eflapegrastim in people with Breast Neoplasms, run by Eunseong Medical Foundation Good GANG-AN HOSPITAL at 1 site in South Korea.
Trial summary
Patients who experienced neutropenia after receiving pegfilgrastim on day 1 of the first round are randomly assigned to either the control or experimental arm. Patients in the control arm continue pegfilgrastim injection on day 1 while patients in the experimental arm will receive pegfilgrastim injection on day 3 to… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Eflapegrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Nov 2023to Jul 2025
- Phase
- Phase 4
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 to 75 years old as of the date of study registration.
- Patients with histologically confirmed invasive adenocarcinoma.
- Patients with confirmed estrogen receptor, progesterone receptor, and Her2 receptor status.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients with a left ventricular ejection fraction (LVEF) ≥55%.
- Patients who have agreed to participate in this trial and have provided written consent.
Who cannot join
- Patients with a history of breast cancer treatment
- Patients with a history of chemotherapy, radiation therapy, immunotherapy, or biotherapy for malignancies other than breast cancer
- Patients with infectious diseases
- Patients with serious illnesses that may affect this clinical trial: cardiovascular disease, kidney disease, liver disease, endocrine disease, tumors, or diabetes
- Other individuals deemed by the clinical trial investigators to be unable to participate in the trial.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Good Gang-An Hospital
Busan
Chang Wan Jeon, Ph.D, s8668s@hanmai.net
Jangmoo Byeon, Ph.D
About this study
Official title: Reducing Neutropenia Incidence by Changing the Date of Eflapegrastim Administration in Breast Cancer Patients Who Have Experienced Neutropenia After Chemotherapy
Patients who experienced neutropenia after receiving pegfilgrastim on day 1 of the first round are randomly assigned to either the control or experimental arm. Patients in the control arm continue pegfilgrastim injection on day 1 while patients in the experimental arm will receive pegfilgrastim injection on day 3 to see if changing the pegfilgrastim administration date from day 1 to day 3 starting from the second round of chemotherapy could reduce the incidence of neutropenia
Read the detailed description
The use of pegfilgrastim, which has a long-lasting effect in the human body, after myelosuppressive chemotherapy for solid tumors, including breast cancer, and blood cancers has led to a decrease in the incidence of neutropenia, including febrile neutropenia, and a reduction in medical costs by shortening hospitalization periods related to side effects of chemotherapy. During the early stages of drug development, there was controversy over the timing of pegfilgrastim administration, and attempts were made to administer it at various times, from the day of chemotherapy to the day of neutropenia began. However, based on several studies, it is now known that patients who receive pegfilgrastim on the day of chemotherapy or after 4 days of chemotherapy have a higher incidence of febrile neutropenia. Therefore, administering pegfilgrastim on day 1-3 after chemotherapy is ideal, but in reality, it is often difficult for patients to visit the hospital multiple times after chemotherapy, so many patients are discharged after receiving pegfilgrastim on day 1. The FDA and National Comprehensive Cancer Network (NCCN) guidelines also recommend administration on day 1. It is known that patients who experience neutropenia after the first round of chemotherapy are more likely to experience it again in subsequent rounds. The investigators aimed to see whether changing the pegfilgrastim administration date from day 1 to day 3 starting from the second round of chemotherapy for patients who experienced neutropenia after receiving pegfilgrastim on day 1 of the first round can reduce the incidence of neutropenia.
- Conditions
- Breast Neoplasms
- Being tested
- Eflapegrastim
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EflapegrastimDrug
Also called Rolvedon, Eflapegrastim-xnst, HM-10460A, SPI-2012
long-acting granulocyte-colony stimulating factor
| Study group | Role | What they receive |
|---|---|---|
| Day1 Group | Active comparator | Eflapegrastim administration on day 1 (24 hours after completion of chemotherapy) Receives: Drug: Eflapegrastim |
| Day 3 Group | Experimental | Eflapegrastim administration on day 3 (the third day after completion of chemotherapy Receives: Drug: Eflapegrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of severe neutropenia Incidence rate of severe neutropenia
The incidence rates of Grade 4 neutropenia (ANC < 500 respectively)
Measured: cycle 2-5 (21 days for each cycle), 105 days
Secondary outcomes (3)
Duration of severe neutropenia
number of consecutive days ANC lower than 500
Measured: cycle 2-5 (21 days for each cycle), 105 days
Incidence rate of febrile neutropenia
Severe neutropenia with fever. Fever is defined as below
- 37.5℃ single axillary temperature
- 38.0℃ single ear probe temperature
- 38.3℃ single oral temperature
- 38.0℃ oral temperature over 1 hour in the absence of an obvious cause
Measured: cycle 2-5 (21 days for each cycle), 105 days
Incidence rate of neutropenia related death
Death related chemotherapy induced neutropenia sepsis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start7 Nov 2023
- Primary completionJan 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunseong Medical Foundation Good GANG-AN HOSPITAL
- Sponsor type
- University, hospital or other
- Collaborators
- Hanmi Pharmaceutical Company Limited
- Responsible party
- Principal investigator, Changwan Jeon, Eunseong Medical Foundation Good GANG-AN HOSPITAL
- Investigators
- Chang Wan Jeon, Ph.D, Principal investigator, Surgical Oncologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949333
- Sponsor's protocol ID
- GGAH 2022-10
- Acronym
- NEUTHREE
- Status last verified
- Feb 2024
- First submitted
- 30 May 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meropol NJ, Miller LL, Korn EL, Braitman LE, MacDermott ML, Schuchter LM. Severe myelosuppression resulting from concurrent administration of granulocyte colony-stimulating factor and cytotoxic chemotherapy. J Natl Cancer Inst. 1992 Aug 5;84(15):1201-3. doi: 10.1093/jnci/84.15.1201. No abstract available.
PubMed 1378905Rowinsky EK, Grochow LB, Sartorius SE, Bowling MK, Kaufmann SH, Peereboom D, Donehower RC. Phase I and pharmacologic study of high doses of the topoisomerase I inhibitor topotecan with granulocyte colony-stimulating factor in patients with solid tumors. J Clin Oncol. 1996 Apr;14(4):1224-35. doi: 10.1200/JCO.1996.14.4.1224.
PubMed 8648378Weycker D, Bensink M, Lonshteyn A, Doroff R, Chandler D. Risk of chemotherapy-induced febrile neutropenia by day of pegfilgrastim prophylaxis in US clinical practice from 2010 to 2015. Curr Med Res Opin. 2017 Dec;33(12):2107-2113. doi: 10.1080/03007995.2017.1386858. Epub 2017 Oct 16.
PubMed 28958157Weycker D, Li X, Tzivelekis S, Atwood M, Garcia J, Li Y, Reiner M, Lyman GH. Burden of Chemotherapy-Induced Febrile Neutropenia Hospitalizations in US Clinical Practice, by Use and Patterns of Prophylaxis with Colony-Stimulating Factor. Support Care Cancer. 2017 Feb;25(2):439-447. doi: 10.1007/s00520-016-3421-x. Epub 2016 Oct 12.
PubMed 27734153Lyman GH, Allcott K, Garcia J, Stryker S, Li Y, Reiner MT, Weycker D. The effectiveness and safety of same-day versus next-day administration of long-acting granulocyte colony-stimulating factors for the prophylaxis of chemotherapy-induced neutropenia: a systematic review. Support Care Cancer. 2017 Aug;25(8):2619-2629. doi: 10.1007/s00520-017-3703-y. Epub 2017 May 8.
PubMed 28484882Kaufman PA, Paroly W, Rinaldi D. Randomized double blind phase 2 study evaluating same-day vs. next-day administration of pegfilgrastim with docetaxel, doxorubicin and cyclophosphamide (TAC) in women with early stage and advanced breast cancer. Breast Cancer Res Treat 2004;88:S59.
Saven A, Schwartzberg L, Kaywin P, et al. Randomized, double-blind, phase 2, study evaluating same-day vs next-day administration of pegfilgrastim with R-CHOP in non-Hodgkin's lymphoma patients. J ClinOncol2006;24:7570.
Leonard RC, Miles D, Thomas R, Nussey F; UK Breast Cancer Neutropenia Audit Group. Impact of neutropenia on delivering planned adjuvant chemotherapy: UK audit of primary breast cancer patients. Br J Cancer. 2003 Dec 1;89(11):2062-8. doi: 10.1038/sj.bjc.6601279.
PubMed 14647139Hughes WT, Armstrong D, Bodey GP, Bow EJ, Brown AE, Calandra T, Feld R, Pizzo PA, Rolston KV, Shenep JL, Young LS. 2002 guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis. 2002 Mar 15;34(6):730-51. doi: 10.1086/339215. Epub 2002 Feb 13. No abstract available.
PubMed 11850858Tamura K. Clinical guidelines for the management of neutropenic patients with unexplained fever in Japan: validation by the Japan Febrile Neutropenia Study Group. Int J Antimicrob Agents. 2005 Dec;26 Suppl 2:S123-7; discussion S133-40. doi: 10.1016/j.ijantimicag.2005.08.001. Epub 2005 Oct 24.
PubMed 16249072
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Neutropenia Incidence by Changing the Date of Eflapegrastim Administration in Breast Cancer Patients Who Have Experienced Neutropenia After Chemotherapy
- ClinicalTrials.gov ID
- NCT05949333
- Acronym / sponsor ID
- NEUTHREE / GGAH 2022-10
- Conditions
- Breast Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eunseong Medical Foundation Good GANG-AN HOSPITALUniversity, hospital or other
- Collaborators
- Hanmi Pharmaceutical Company Limited
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 18 Jul 2023 (actual)
- 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.
Patients who experienced neutropenia after receiving pegfilgrastim on day 1 of the first round are randomly assigned to either the control or experimental arm. Patients in the control arm continue pegfilgrastim injection on day 1 while patients in the experimental arm will receive pegfilgrastim injection on day 3 to see if changing the pegfilgrastim administration date from day 1 to day 3 starting from the second round of chemotherapy could reduce the incidence of neutropenia
Detailed description
The use of pegfilgrastim, which has a long-lasting effect in the human body, after myelosuppressive chemotherapy for solid tumors, including breast cancer, and blood cancers has led to a decrease in the incidence of neutropenia, including febrile neutropenia, and a reduction in medical costs by shortening hospitalization periods related to side effects of chemotherapy. During the early stages of drug development, there was controversy over the timing of pegfilgrastim administration, and attempts were made to administer it at various times, from the day of chemotherapy to the day of neutropenia began. However, based on several studies, it is now known that patients who receive pegfilgrastim on the day of chemotherapy or after 4 days of chemotherapy have a higher incidence of febrile neutropenia. Therefore, administering pegfilgrastim on day 1-3 after chemotherapy is ideal, but in reality, it is often difficult for patients to visit the hospital multiple times after chemotherapy, so many patients are discharged after receiving pegfilgrastim on day 1. The FDA and National Comprehensive Cancer Network (NCCN) guidelines also recommend administration on day 1. It is known that patients who experience neutropenia after the first round of chemotherapy are more likely to experience it again in subsequent rounds. The investigators aimed to see whether changing the pegfilgrastim administration date from day 1 to day 3 starting from the second round of chemotherapy for patients who experienced neutropenia after receiving pegfilgrastim on day 1 of the first round can reduce the incidence of neutropenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day1 Group | Active comparator | Drug: EflapegrastimEflapegrastim administration on day 1 (24 hours after completion of chemotherapy) |
| Day 3 Group | Experimental | Drug: EflapegrastimEflapegrastim administration on day 3 (the third day after completion of chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 18 to 75 years old as of the date of study registration.
- Patients with histologically confirmed invasive adenocarcinoma.
- Patients with confirmed estrogen receptor, progesterone receptor, and Her2 receptor status.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients with a left ventricular ejection fraction (LVEF) ≥55%.
Key exclusion criteria (5 listed)
- Patients with a history of breast cancer treatment
- Patients with a history of chemotherapy, radiation therapy, immunotherapy, or biotherapy for malignancies other than breast cancer
- Patients with infectious diseases
- Patients with serious illnesses that may affect this clinical trial: cardiovascular disease, kidney disease, liver disease, endocrine disease, tumors, or diabetes
- Other individuals deemed by the clinical trial investigators to be unable to participate in the trial.
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 |
|---|---|---|
| EflapegrastimAlso: Rolvedon, Eflapegrastim-xnst, HM-10460A, SPI-2012long-acting granulocyte-colony stimulating factor | Drug | Day 3 Group, Day1 Group |
Primary outcome
Incidence rate of severe neutropenia Incidence rate of severe neutropenia
Time frame: cycle 2-5 (21 days for each cycle), 105 days
The incidence rates of Grade 4 neutropenia (ANC < 500 respectively)
3 secondary outcomes
Duration of severe neutropenia
Time frame: cycle 2-5 (21 days for each cycle), 105 days
Incidence rate of febrile neutropenia
Time frame: cycle 2-5 (21 days for each cycle), 105 days
Incidence rate of neutropenia related death
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Background: PubMed 1378905Meropol NJ, Miller LL, Korn EL, Braitman LE, MacDermott ML, Schuchter LM. Severe myelosuppression resulting from concurrent administration of granulocyte colony-stimulating factor and cytotoxic chemotherapy. J Natl Cancer Inst. 1992 Aug 5;84(15):1201-3. doi: 10.1093/jnci/84.15.1201. No abstract available.
- Background: PubMed 8648378Rowinsky EK, Grochow LB, Sartorius SE, Bowling MK, Kaufmann SH, Peereboom D, Donehower RC. Phase I and pharmacologic study of high doses of the topoisomerase I inhibitor topotecan with granulocyte colony-stimulating factor in patients with solid tumors. J Clin Oncol. 1996 Apr;14(4):1224-35. doi: 10.1200/JCO.1996.14.4.1224.
- Background: PubMed 28958157Weycker D, Bensink M, Lonshteyn A, Doroff R, Chandler D. Risk of chemotherapy-induced febrile neutropenia by day of pegfilgrastim prophylaxis in US clinical practice from 2010 to 2015. Curr Med Res Opin. 2017 Dec;33(12):2107-2113. doi: 10.1080/03007995.2017.1386858. Epub 2017 Oct 16.
- Background: PubMed 27734153Weycker D, Li X, Tzivelekis S, Atwood M, Garcia J, Li Y, Reiner M, Lyman GH. Burden of Chemotherapy-Induced Febrile Neutropenia Hospitalizations in US Clinical Practice, by Use and Patterns of Prophylaxis with Colony-Stimulating Factor. Support Care Cancer. 2017 Feb;25(2):439-447. doi: 10.1007/s00520-016-3421-x. Epub 2016 Oct 12.
- Background: PubMed 28484882Lyman GH, Allcott K, Garcia J, Stryker S, Li Y, Reiner MT, Weycker D. The effectiveness and safety of same-day versus next-day administration of long-acting granulocyte colony-stimulating factors for the prophylaxis of chemotherapy-induced neutropenia: a systematic review. Support Care Cancer. 2017 Aug;25(8):2619-2629. doi: 10.1007/s00520-017-3703-y. Epub 2017 May 8.
- BackgroundKaufman PA, Paroly W, Rinaldi D. Randomized double blind phase 2 study evaluating same-day vs. next-day administration of pegfilgrastim with docetaxel, doxorubicin and cyclophosphamide (TAC) in women with early stage and advanced breast cancer. Breast Cancer Res Treat 2004;88:S59.
- BackgroundSaven A, Schwartzberg L, Kaywin P, et al. Randomized, double-blind, phase 2, study evaluating same-day vs next-day administration of pegfilgrastim with R-CHOP in non-Hodgkin's lymphoma patients. J ClinOncol2006;24:7570.
- Background: PubMed 14647139Leonard RC, Miles D, Thomas R, Nussey F; UK Breast Cancer Neutropenia Audit Group. Impact of neutropenia on delivering planned adjuvant chemotherapy: UK audit of primary breast cancer patients. Br J Cancer. 2003 Dec 1;89(11):2062-8. doi: 10.1038/sj.bjc.6601279.
- Background: PubMed 11850858Hughes WT, Armstrong D, Bodey GP, Bow EJ, Brown AE, Calandra T, Feld R, Pizzo PA, Rolston KV, Shenep JL, Young LS. 2002 guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis. 2002 Mar 15;34(6):730-51. doi: 10.1086/339215. Epub 2002 Feb 13. No abstract available.
- Background: PubMed 16249072Tamura K. Clinical guidelines for the management of neutropenic patients with unexplained fever in Japan: validation by the Japan Febrile Neutropenia Study Group. Int J Antimicrob Agents. 2005 Dec;26 Suppl 2:S123-7; discussion S133-40. doi: 10.1016/j.ijantimicag.2005.08.001. Epub 2005 Oct 24.
- Individual participant dataSharing planned: No
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Chang Wan Jeon, Ph.D principal investigator
Surgical Oncologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eflapegrastim in people with Breast Neoplasms, run by Eunseong Medical Foundation Good GANG-AN HOSPITAL 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Feb 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chief of Breast Center (82519338719, s8668s@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of severe neutropenia Incidence rate of severe neutropenia (time frame: cycle 2-5 (21 days for each cycle), 105 days). 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 NCT05949333, which also lists 10 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 23 Feb 2024.