Breast CancerPhase 2NCT03575520
Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients
A Phase 2 study testing Pegfilgrastim and Doxorubicin/Cyclophosphamide(AC) treatment in people with Breast Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
This is a prospective, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with pegteograstim support in Korean early breast cancer. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pegfilgrastim and Doxorubicin/Cyclophosphamide(AC) treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jun 2016to 15 Mar 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological diagnosis of a primary breast cancer (stage I-III)
- Age > 18 years of age and Age < 66 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 1
- Patients who have plan to receive neoadjuvant or adjuvant dose-dense AC chemotherapy
- Adequate organ functions
- ANC ≥1500 cells/mm3
Show all 11Show fewer
- PLT ≥100,000 cells/mm3
- CCr ≥50 mL/min, or Serum Cr <1.5 x (upper limit of normal, ULN)
- Total bilirubin ≤1.5 x ULN
- AST (SGOT) ≤2.5 x ULN
- ALT (SGPT) ≤2.5 x ULN
Who cannot join
- Previous chemotherapy history
- Previous bone marrow transplantation history
- Sickle cell anemia
- Radiation therapy within 4 weeks from enrollment
- Previous pegfilgrastim, filgrastim or other colony-stimulating factor treatment within 4 weeks from enrollment
- Clinically significant systemic illness (serious infection, liver, kidney, heart disease)
- Pregnant, breast feeding women
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Medical Oncology, Severance Breast Cancer Clinic, Yonsei Cancer Center, Severance Hospital, Yonsei University Health System
Seoul, 03722
About this study
Official title: A Phase II Study to Evaluate the Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients Receiving Dose-dense Doxorubicin/Cyclophosphamide
This is a prospective, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with pegteograstim support in Korean early breast cancer.
Read the detailed description
Pegteograstim is a novel monoPEGylated recombinant human G-CSF. In this prospective study, the incidence of febrile neutropenia during four cycles of dose dense (DD) doxorubicin/cyclophosphamide (AC) with pegtoegrastim support is being investigated.
The primary objective of this study is to determine the incidence of febrile neutropenia during four cycles of DD AC with pegteograstim support (8 weeks).
Patients received four cycles of DD-AC (60 mg/m² doxorubicin and 600 mg/m² cyclophosphamide administered intravenously on day 1 every two weeks).
A fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy).
Clinical, hematological, and biochemical assessments were done before the start of each cycle.
Adverse events (AEs) were graded using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE version 4.03).
- Conditions
- Breast Cancer
- Being tested
- Pegfilgrastim, Doxorubicin/Cyclophosphamide(AC) treatment
- Keywords
- breast cancer, dose-dense chemotherapy, pegfilgrastim
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegfilgrastimDrug
A fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy).
Doxorubicin/Cyclophosphamide(AC) treatmentDrug
doxorubicin 60mg/m2 IV every 2 weeks cyclophosphamide 600mg/m2 IV every 2 weeks
Four cycles of dose dense AC treatment will be given every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Peg group | Experimental | Not described Receives: Drug: Pegfilgrastim; Drug: Doxorubicin/Cyclophosphamide(AC) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of febrile neutropenia (FN)
FN is defined as neutropenia (<500 neutrophils/μL) with a febrile event (a single oral temperature of ≥38.3°C or a temperature of ≥38.0°C sustained over a one-hour period).
Measured: 2months
Secondary outcomes (4)
the incidences of febrile neutropenia during the first cycle of chemotherapy
Measured: At the end of Cycle 1 (each cycle is 14days)
the incidences of hospitalization for FN
Measured: 2months
number of grade 3 or 4 neutropenia in the first cycle of DD-AC
Measured: 2months
the incidences of dose delay or reduction of chemotherapy
Measured: 2months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start7 Jun 2016
- Primary completion15 Feb 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575520
- Sponsor's protocol ID
- 4-2015-0813
- Status last verified
- Jun 2018
- First submitted
- 6 Jun 2018
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients Receiving Dose-dense Doxorubicin/Cyclophosphamide
- ClinicalTrials.gov ID
- NCT03575520
- Acronym / sponsor ID
- 4-2015-0813
- Conditions
- Breast Cancer
- Keywords
- breast cancer, dose-dense chemotherapy, pegfilgrastim
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Jun 2016 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 2 Jul 2018 (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.
This is a prospective, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with pegteograstim support in Korean early breast cancer.
Detailed description
Pegteograstim is a novel monoPEGylated recombinant human G-CSF. In this prospective study, the incidence of febrile neutropenia during four cycles of dose dense (DD) doxorubicin/cyclophosphamide (AC) with pegtoegrastim support is being investigated.
The primary objective of this study is to determine the incidence of febrile neutropenia during four cycles of DD AC with pegteograstim support (8 weeks).
Patients received four cycles of DD-AC (60 mg/m² doxorubicin and 600 mg/m² cyclophosphamide administered intravenously on day 1 every two weeks).
A fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy).
Clinical, hematological, and biochemical assessments were done before the start of each cycle.
Adverse events (AEs) were graded using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE version 4.03).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peg group | Experimental | Drug: Pegfilgrastim, Drug: Doxorubicin/Cyclophosphamide(AC) treatment |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histological or cytological diagnosis of a primary breast cancer (stage I-III)
- Age > 18 years of age and Age < 66 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 1
- Patients who have plan to receive neoadjuvant or adjuvant dose-dense AC chemotherapy
- Adequate organ functions
Key exclusion criteria (7 listed)
- Previous chemotherapy history
- Previous bone marrow transplantation history
- Sickle cell anemia
- Radiation therapy within 4 weeks from enrollment
- Previous pegfilgrastim, filgrastim or other colony-stimulating factor treatment within 4 weeks from enrollment
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 |
|---|---|---|
| PegfilgrastimA fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy). | Drug | Peg group |
| Doxorubicin/Cyclophosphamide(AC) treatmentdoxorubicin 60mg/m2 IV every 2 weeks cyclophosphamide 600mg/m2 IV every 2 weeks Four cycles of dose dense AC treatment will be given every 2 weeks. | Drug | Peg group |
Primary outcome
the incidence of febrile neutropenia (FN)
Time frame: 2months
FN is defined as neutropenia (<500 neutrophils/μL) with a febrile event (a single oral temperature of ≥38.3°C or a temperature of ≥38.0°C sustained over a one-hour period).
4 secondary outcomes
the incidences of febrile neutropenia during the first cycle of chemotherapy
Time frame: At the end of Cycle 1 (each cycle is 14days)
the incidences of hospitalization for FN
Time frame: 2months
number of grade 3 or 4 neutropenia in the first cycle of DD-AC
Time frame: 2months
the incidences of dose delay or reduction of chemotherapy
Time frame: 2months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pegfilgrastim and Doxorubicin/Cyclophosphamide(AC) treatment in people with Breast Cancer, run by Yonsei University 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 11 inclusion and 7 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: finished, as of the sponsor's last update on 2 Jul 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the incidence of febrile neutropenia (FN) (time frame: 2months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2018.