Breast CancerPhase 3NCT03343145
A Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients
A Phase 3 study testing Leucostim 5µg/kg/day and Neupogen 5µg/kg/day in people with Breast Cancer, run by Dong-A ST Co., Ltd. at 1 site in Indonesia.
Trial summary
A study to compare the efficacy, safety and immunogenicity of Leucostim® to those of Neupogen® in patients with breast cancer intended to be treated with TAC regimen as a myelosuppressive chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Leucostim 5µg/kg/day and Neupogen 5µg/kg/day
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Jan 2017to 29 Jul 2019
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to provide a written informed consent
- Men or women ≥ 18 and ≤ 70 years of age
- Histologically or cytologically confirmed breast cancer (Stage II to Stage IV)
- Be scheduled to receive TAC regimen as adjuvant therapy
- Subjects who meet the conditions at screening test as follows;
- Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
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- Platelet Count ≥ 100,000/mm3
- ECOG Performance Status : 0~2
- Adequate renal function (Creatinine ≤ 1.5 x ULN at screening test)
- Adequate hepatic function at screening test (Total bilirubin/AST/ALT ≤ 1.5 x ULN, ALP ≤ 2.5 x ULN at screening test)
Who cannot join
- Prior chemotherapy experiences
- Prior bone marrow or stem cell transplantation
- History of treatment with hematopoietic growth factors (e.g. G-CSF, peg-G-CSF, erythropoietin)
- History of prior malignancy other than breast cancer or surgically cured malignancies within 5 years of informed consent date
- Participation in any other clinical study within 4 weeks of informed consent date or planning to simultaneously participate in another clinical study
- Currently receiving radiation therapy or having completed radiation therapy within 4 weeks of informed consent date
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- Active infection which may require systemic antimicrobial or antiviral therapy during the study (e.g. ANC ≥ 12,000/mm3 or Body Temperature > 38.2 degrees C (100.8 degrees F))
- History of systemic antibiotic use within 72 hours prior to chemotherapy
- History of hypersensitivity to the investigational product, components or similar products
- HIV positive
- Pregnant or lactating women, or women of child-bearing potential who are not willing to follow a reliable and effective contraceptive measure during the course of the study and for at least one month after the completion of the study
- Any other cases that is considered by the investigator as an exclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Active-controlled, Multi-center, Phase III Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy
A study to compare the efficacy, safety and immunogenicity of Leucostim® to those of Neupogen® in patients with breast cancer intended to be treated with TAC regimen as a myelosuppressive chemotherapy.
Read the detailed description
TAC regimen (docetaxel, doxorubicin and cyclophosphamide) is recommended for the adjuvant treatment of breast cancer patients. The TAC regimen is known to lead to significant hematological toxicity and induces febrile neutropenia with a rate > 20%. The use of primary G-CSF prophylaxis with the TAC regimen is recommended by guidelines. e.g., by the European Organisation for Research and Treatment of Cancer as well as by the guideline on myeloid growth factors of the National Comprehensive Cancer Network.6,7 This study is to compare the efficacy, safety and immunogenicity of Leucostim® to those of Neupogen® in patients with breast cancer intended to be treated with TAC regimen as a myelosuppressive chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Leucostim 5µg/kg/day, Neupogen 5µg/kg/day
- Keywords
- Neutropenia
- Medical subject headings
- Breast Neoplasms, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leucostim 5µg/kg/dayBiological
5µg/kg/day (based on actual body weight) Leucostim®, subcutaneously, once a day, for up to 14 days or until the target ANC of 10,000/mm3 following the expected chemotherapy-induced ANC nadir
Neupogen 5µg/kg/dayBiological
5µg/kg/day (based on actual body weight) Neupogen®, subcutaneously, once a day, for up to 14 days or until the target ANC of 10,000/mm3 following the expected chemotherapy-induced ANC nadir
| Study group | Role | What they receive |
|---|---|---|
| Test Drug Group | Experimental | Leucostim 5µg/kg/day Receives: Biological: Leucostim 5µg/kg/day |
| Reference Drug Group | Active comparator | Neupogen 5µg/kg/day Receives: Biological: Neupogen 5µg/kg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean duration of Grade 4 Neutropenia (i.e. ANC < 500/mm3) in Cycle 1
Measured: Maximum of 14 Days
Secondary outcomes (3)
Depth of ANC nadir after chemotherapy in Cycle 1
Measured: Maximum of 14 Days
Time to ANC recovery in Cycle 1
Measured: Maximum of 14 Days
Incidence of febrile neutropenia in Cycle 1;
Measured: Maximum of 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start12 Jan 2017
- Primary completion28 Jan 2019
- Study completion29 Jul 2019
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.
- 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
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343145
- Sponsor's protocol ID
- DAGCSF_NP_III
- Status last verified
- Dec 2020
- First submitted
- 10 Nov 2017
- Last updated
- 28 Dec 2020
- 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 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Active-controlled, Multi-center, Phase III Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy
- ClinicalTrials.gov ID
- NCT03343145
- Acronym / sponsor ID
- DAGCSF_NP_III
- Conditions
- Breast Cancer
- Keywords
- Neutropenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 17 Nov 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.
A study to compare the efficacy, safety and immunogenicity of Leucostim® to those of Neupogen® in patients with breast cancer intended to be treated with TAC regimen as a myelosuppressive chemotherapy.
Detailed description
TAC regimen (docetaxel, doxorubicin and cyclophosphamide) is recommended for the adjuvant treatment of breast cancer patients. The TAC regimen is known to lead to significant hematological toxicity and induces febrile neutropenia with a rate > 20%. The use of primary G-CSF prophylaxis with the TAC regimen is recommended by guidelines. e.g., by the European Organisation for Research and Treatment of Cancer as well as by the guideline on myeloid growth factors of the National Comprehensive Cancer Network.6,7 This study is to compare the efficacy, safety and immunogenicity of Leucostim® to those of Neupogen® in patients with breast cancer intended to be treated with TAC regimen as a myelosuppressive chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Drug Group | Experimental | Biological: Leucostim 5µg/kg/dayLeucostim 5µg/kg/day |
| Reference Drug Group | Active comparator | Biological: Neupogen 5µg/kg/dayNeupogen 5µg/kg/day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing to provide a written informed consent
- Men or women ≥ 18 and ≤ 70 years of age
- Histologically or cytologically confirmed breast cancer (Stage II to Stage IV)
- Be scheduled to receive TAC regimen as adjuvant therapy
- Subjects who meet the conditions at screening test as follows;
Key exclusion criteria (12 listed)
- Prior chemotherapy experiences
- Prior bone marrow or stem cell transplantation
- History of treatment with hematopoietic growth factors (e.g. G-CSF, peg-G-CSF, erythropoietin)
- History of prior malignancy other than breast cancer or surgically cured malignancies within 5 years of informed consent date
- Participation in any other clinical study within 4 weeks of informed consent date or planning to simultaneously participate in another clinical study
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 |
|---|---|---|
| Leucostim 5µg/kg/day5µg/kg/day (based on actual body weight) Leucostim®, subcutaneously, once a day, for up to 14 days or until the target ANC of 10,000/mm3 following the expected chemotherapy-induced ANC nadir | Biological | Test Drug Group |
| Neupogen 5µg/kg/day5µg/kg/day (based on actual body weight) Neupogen®, subcutaneously, once a day, for up to 14 days or until the target ANC of 10,000/mm3 following the expected chemotherapy-induced ANC nadir | Biological | Reference Drug Group |
Primary outcome
Mean duration of Grade 4 Neutropenia (i.e. ANC < 500/mm3) in Cycle 1
Time frame: Maximum of 14 Days
3 secondary outcomes
Depth of ANC nadir after chemotherapy in Cycle 1
Time frame: Maximum of 14 Days
Time to ANC recovery in Cycle 1
Time frame: Maximum of 14 Days
Incidence of febrile neutropenia in Cycle 1;
Time frame: Maximum of 14 Days
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 28 Dec 2020.
- 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 3 study testing Leucostim 5µg/kg/day and Neupogen 5µg/kg/day in people with Breast Cancer, run by Dong-A ST Co., Ltd. at 1 site in Indonesia.
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 10 inclusion and 12 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 28 Dec 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 Indonesia. 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?
Mean duration of Grade 4 Neutropenia (i.e. ANC < 500/mm3) in Cycle 1 (time frame: Maximum of 14 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 28 Dec 2020.