Breast Cancer FemalePhase 3NCT03381417
Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients.
A Phase 3 study testing pegcyte and Neulastim in people with Breast Cancer Female, run by Nanogen Pharmaceutical Biotechnology Joint Stock Company at 1 site in Vietnam.
Trial summary
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 practice in Vietnam for breast cancer, this regimen is to facilitate the dose-dense… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- pegcyte and Neulastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteVietnam
- Study dates
- 6 Oct 2016to 6 Nov 2017
- Phase
- Phase 3
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged between 18 - 65 years.
- Patients with histological confirmed primary invasive breast cancer; stage I, II or III.
- Patients had no prior chemotherapy treatments.
- Patients scheduled to undergo myelosuppressive Doxorubicin and Cyclophosphamide chemotherapy for 04 cycles, and Paclitaxel chemotherapy for the next 04 cycles; patients were available for 14 days of each cycle for the first 03 chemotherapy cycles.
- Patients with baseline ANC ≥ 1.5 x 109/L, PLT ≥ 100 x 109/L, HgB ≥ 9 g/dL, WBC ≥ 3,000/mL and albumin ≥ 3.0 g/dL.
- Performance status as per ECOG (Eastern Cooperative Oncology Group) score 0, 1 or 2.
- Willing to give written and signed informed consent.
Who cannot join
- Patients with prior exposure of G-CSF or GM-CSF or its pegylated products in clinical development less than 6 months prior to randomization.
- Myelotoxic concomitant treatment such as chloramphenicol, methotrexate, immunomodulating agents, interferons during 10 days before randomization.
- Received systemic antibiotic treatment within 72 hours of chemotherapy.
- Chronic use of corticosteroids, prior bone marrow or stem cell transplant.
- Patients who had an immediate/ concurrent exposure to radiotherapy or surgery (within 4 weeks).
- Severe medical disease: cardiovascular, hepatic, renal, pulmonary…
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- Known cases of hematological disease (sickle cell anemia, AML…)
- History of HIV positive, active hepatitis.
- Pregnant and lactating women or patients planning to become pregnant.
- Known allergic reactions to study medications.
- Positive to anti-pegfilgrastim antibody test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Parallel Study Comparing Efficacy and Safety of Pegcyte (Nanogen) and Reference Product Neulastim (Roche) for Prevention of Chemotherapy (Accelerated AC Regimen)Induced Neutropenia 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 practice in Vietnam for breast cancer, this regimen is to facilitate the dose-dense schedule, patients receive every-2-week therapy along with G-CSF support. the accelerated dose-dense schedule improve disease-free and overall survival among women with breast cancer .Primary objective of this study is to compare the efficacy and safety of Nanogen's Pegcyte and Roche's Neulastim for prevention of chemotherapy (Accelerated AC regimen)-induced neutropenia on breast cancer patients. Breast cancer patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will be recruited in this trial. All eligible patients receive single subcutaneous injection of study drugs 24 hours after chemotherapy administration in each cycle for 3 consecutive cycles. Efficacy and safety assessments will be assessed based on the incidence of severe neutropenia in combination of temperature > 38.3℃ or sepsis or life threatening infection and incidence of serious adverse events.
- Conditions
- Breast Cancer Female
- Being tested
- pegcyte, Neulastim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegcyteDrug
Also called pegfilgrastim
Eligible patients are scheduled to receive three cycles of chemotherapy every two weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
NeulastimDrug
Also called pegfilgrastim
Eligible patients are scheduled to receive three cycles of chemotherapy every two weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
| Study group | Role | What they receive |
|---|---|---|
| Pegcyte (Nanogen pegfilgrastim) | Experimental | 6 mg in each cycle Receives: Drug: pegcyte |
| Neulastim (Roche pegfilgrastim) | Active comparator | 6 mg in each cycle Receives: Drug: Neulastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who developed Febrile neutropenia in cycle 1,2 and 3
Measured: 0 to 42 days)
Secondary outcomes (5)
Incidence of grade 4 severe neutropenia
Measured: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)
Incidence of antibiotics use
Measured: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)
Incidence of adverse events
Measured: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)
Changes in laboratory safety parameters
including vital signs
Measured: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)
Presence of antibodies against Pegfilgrastim
Measured: at the end of cycle 3 (42 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start6 Oct 2016
- Primary completion6 Nov 2017
- Study completion6 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381417
- Sponsor's protocol ID
- NNG05
- Status last verified
- Dec 2017
- First submitted
- 11 Dec 2017
- Last updated
- 2 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Study Comparing Efficacy and Safety of Pegcyte (Nanogen) and Reference Product Neulastim (Roche) for Prevention of Chemotherapy (Accelerated AC Regimen)Induced Neutropenia in Breast-cancer Patients.
- ClinicalTrials.gov ID
- NCT03381417
- Acronym / sponsor ID
- NNG05
- Conditions
- Breast Cancer Female
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2016 (actual)
- Primary completion
- 6 Nov 2017 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 22 Dec 2017 (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.
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 practice in Vietnam for breast cancer, this regimen is to facilitate the dose-dense schedule, patients receive every-2-week therapy along with G-CSF support. the accelerated dose-dense schedule improve disease-free and overall survival among women with breast cancer .Primary objective of this study is to compare the efficacy and safety of Nanogen's Pegcyte and Roche's Neulastim for prevention of chemotherapy (Accelerated AC regimen)-induced neutropenia on breast cancer patients. Breast cancer patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will be recruited in this trial. All eligible patients receive single subcutaneous injection of study drugs 24 hours after chemotherapy administration in each cycle for 3 consecutive cycles. Efficacy and safety assessments will be assessed based on the incidence of severe neutropenia in combination of temperature > 38.3℃ or sepsis or life threatening infection and incidence of serious adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pegcyte (Nanogen pegfilgrastim) | Experimental | Drug: pegcyte6 mg in each cycle |
| Neulastim (Roche pegfilgrastim) | Active comparator | Drug: Neulastim6 mg in each cycle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients aged between 18 - 65 years.
- Patients with histological confirmed primary invasive breast cancer; stage I, II or III.
- Patients had no prior chemotherapy treatments.
- Patients scheduled to undergo myelosuppressive Doxorubicin and Cyclophosphamide chemotherapy for 04 cycles, and Paclitaxel chemotherapy for the next 04 cycles; patients were available for 14 days of each cycle for the first 03 chemotherapy cycles.
- Patients with baseline ANC ≥ 1.5 x 109/L, PLT ≥ 100 x 109/L, HgB ≥ 9 g/dL, WBC ≥ 3,000/mL and albumin ≥ 3.0 g/dL.
Key exclusion criteria (11 listed)
- Patients with prior exposure of G-CSF or GM-CSF or its pegylated products in clinical development less than 6 months prior to randomization.
- Myelotoxic concomitant treatment such as chloramphenicol, methotrexate, immunomodulating agents, interferons during 10 days before randomization.
- Received systemic antibiotic treatment within 72 hours of chemotherapy.
- Chronic use of corticosteroids, prior bone marrow or stem cell transplant.
- Patients who had an immediate/ concurrent exposure to radiotherapy or surgery (within 4 weeks).
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 |
|---|---|---|
| pegcyteAlso: pegfilgrastimEligible patients are scheduled to receive three cycles of chemotherapy every two weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application. | Drug | Pegcyte (Nanogen pegfilgrastim) |
| NeulastimAlso: pegfilgrastimEligible patients are scheduled to receive three cycles of chemotherapy every two weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application. | Drug | Neulastim (Roche pegfilgrastim) |
Primary outcome
Percentage of patients who developed Febrile neutropenia in cycle 1,2 and 3
Time frame: 0 to 42 days)
5 secondary outcomes
Incidence of grade 4 severe neutropenia
Time frame: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)
Incidence of antibiotics use
Time frame: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)
Incidence of adverse events
Time frame: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)
Changes in laboratory safety parameters
Time frame: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)
Presence of antibodies against Pegfilgrastim
Time frame: at the end of cycle 3 (42 day)
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 Jan 2018.
- 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.
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 3 study testing pegcyte and Neulastim in people with Breast Cancer Female, run by Nanogen Pharmaceutical Biotechnology Joint Stock Company at 1 site in Vietnam.
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 7 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: finished, as of the sponsor's last update on 2 Jan 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 Vietnam. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage of patients who developed Febrile neutropenia in cycle 1,2 and 3 (time frame: 0 to 42 days)). 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 Jan 2018.