Chemotherapy-induced NeutropeniaPhase 2/3NEUGR-002NCT00837265

Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel

A Phase 2/3 study testing Balugrastim, Pegfilgrastim and Chemotherapy Regimen in people with Chemotherapy-induced Neutropenia, run by Teva Branded Pharmaceutical Products R&D, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Determination of the effect of balugrastim on the duration and severity of severe neutropenia. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chemotherapy-induced Neutropenia
What is being tested?: Balugrastim, Pegfilgrastim and Chemotherapy Regimen
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 334 participants
Where: No sites listed yet
Study dates: 21 Aug 2008to 26 Jun 2009
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel).

Who cannot join

Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months).

About this study

Official title: A Randomized Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects With Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel)

Determination of the effect of balugrastim on the duration and severity of severe neutropenia.

Conditions: Chemotherapy-induced Neutropenia
Being tested: Balugrastim, Pegfilgrastim, Chemotherapy Regimen
Keywords: Breast Cancer Supportive Care Neutropenia

What participants receive

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

BalugrastimBiological
Also called Neugranin
Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.
PegfilgrastimDrug
Pegfilgrastim will be administered per dose and schedule specified in the arm description.
Chemotherapy RegimenDrug
The chemotherapy regimen consisting of doxorubicin 60 mg/square meter (m^2) and docetaxel 75 mg/m^2 will be administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles.

Study groups in NCT00837265
Study group	Role	What they receive
Pilot Phase: Balugrastim Low Dose	Experimental	Participants will receive balugrastim low dose administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). Receives: Biological: Balugrastim; Drug: Chemotherapy Regimen
Pilot Phase: Balugrastim Medium Dose	Experimental	Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). Receives: Biological: Balugrastim; Drug: Chemotherapy Regimen
Pilot Phase: Balugrastim High Dose	Experimental	Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). Receives: Biological: Balugrastim; Drug: Chemotherapy Regimen
Pilot Phase: Pegfilgrastim	Active comparator	Participants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). Receives: Drug: Pegfilgrastim; Drug: Chemotherapy Regimen
Main Phase: Balugrastim Medium Dose	Experimental	Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). Receives: Biological: Balugrastim; Drug: Chemotherapy Regimen
Main Phase: Balugrastim High Dose	Experimental	Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). Receives: Biological: Balugrastim; Drug: Chemotherapy Regimen
Main Phase: Pegfilgrastim	Active comparator	Participants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). Receives: Drug: Pegfilgrastim; Drug: Chemotherapy Regimen

What is being measured

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

Duration of Severe Neutropenia in Cycle 1
Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 x 10^9/liter [L]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10^9/L within the cycle.
Measured: Cycle 1 (cycle length = 21 days)

Secondary outcomes (3)

Number of Participants With Febrile Neutropenia
Febrile neutropenia was defined as an imputed or observed ANC <0.5 x 10^9/L and oral temperature ≥38.2 degrees celsius (°C) occurring on the same day. Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.
Measured: Cycles 1 to 4 (each cycle length = 21 days)
Duration of Severe Neutropenia in Cycles 2, 3, and 4
Severe neutropenia was defined as Grade 4 neutropenia (ANC <0.5 x 10^9/L). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10^9/L within the cycle.
Measured: Cycles 2, 3, and 4 (each cycle length = 21 days)
Time to Absolute Neutrophil Count (ANC) Recovery in Cycles 1, 2, 3, and 4
Time to ANC recovery was defined as the time from the nadir ANC to an ANC ≥1.5 x 10^9/L and was calculated for participants with ANC <1.5 x 10^9/L after the beginning of a chemotherapy cycle. Time to ANC recovery was calculated by cycle as the number of days from the nadir (the lowest ANC during a chemotherapy cycle) until a participant reached an ANC >1.5 x 10^9/L.
Measured: Cycles 1, 2, 3, and 4

Timeline

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

21 Aug 200826 Jun 2009

First posted5 Feb 2009 (estimated)
Study start21 Aug 2008
Primary completion26 Jun 2009
Study completion26 Jun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chemotherapy-induced NeutropeniaStudies 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 2/3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 334 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00837265
Sponsor's protocol ID: NEUGR-002
Acronym: NEUGR-002
Status last verified: Apr 2024
First submitted: 4 Feb 2009
Last updated: 3 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

Official record

RecruitingObservational study
Mecapegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Advanced Breast Cancer
Breast Cancer, Chemotherapy-induced Neutropenia
Not yet recruiting
Impact of a Telemonitoring Device on the Occurever at Home in Children at Risk of Chemotherapy-Induced Neutropenia
Oncopediatrics, Febrile Neutropenia
Active, not recruitingPhase 4
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Extensive-stage Small-cell Lung Cancer
Not yet recruitingObservational study
Correlation Between ANC and Bone Pain in Breast Cancer Patients Receiving Long-Acting G-CSF
Breast Cancer, Chemotherapy-Induced Neutropenia
RecruitingPhase 2
Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors
Solid Tumors, Children

All Chemotherapy-induced Neutropenia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects With Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel)
ClinicalTrials.gov ID: NCT00837265
Acronym / sponsor ID: NEUGR-002 / NEUGR-002
Conditions: Chemotherapy-induced Neutropenia
Keywords: Breast Cancer Supportive Care Neutropenia
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 334 participants (actual)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
Study start: 21 Aug 2008 (actual)
Primary completion: 26 Jun 2009 (actual)
Study completion: 26 Jun 2009 (actual)
First posted: 5 Feb 2009 (estimated)
Results: Posted 3 Feb 2023

Clinical summary

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

Determination of the effect of balugrastim on the duration and severity of severe neutropenia.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
Pilot Phase: Balugrastim Low Dose	Experimental	Biological: Balugrastim, Drug: Chemotherapy RegimenParticipants will receive balugrastim low dose administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
Pilot Phase: Balugrastim Medium Dose	Experimental	Biological: Balugrastim, Drug: Chemotherapy RegimenParticipants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
Pilot Phase: Balugrastim High Dose	Experimental	Biological: Balugrastim, Drug: Chemotherapy RegimenParticipants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
Pilot Phase: Pegfilgrastim	Active comparator	Drug: Pegfilgrastim, Drug: Chemotherapy RegimenParticipants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
Main Phase: Balugrastim Medium Dose	Experimental	Biological: Balugrastim, Drug: Chemotherapy RegimenParticipants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
Main Phase: Balugrastim High Dose	Experimental	Biological: Balugrastim, Drug: Chemotherapy RegimenParticipants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
Main Phase: Pegfilgrastim	Active comparator	Drug: Pegfilgrastim, Drug: Chemotherapy RegimenParticipants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel).

Key exclusion criteria (1 listed)

Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months).

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
BalugrastimAlso: NeugraninBalugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.	Biological	Main Phase: Balugrastim High Dose, Main Phase: Balugrastim Medium Dose, Pilot Phase: Balugrastim High Dose, Pilot Phase: Balugrastim Low Dose, Pilot Phase: Balugrastim Medium Dose
PegfilgrastimPegfilgrastim will be administered per dose and schedule specified in the arm description.	Drug	Main Phase: Pegfilgrastim, Pilot Phase: Pegfilgrastim
Chemotherapy RegimenThe chemotherapy regimen consisting of doxorubicin 60 mg/square meter (m^2) and docetaxel 75 mg/m^2 will be administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles.	Drug	Main Phase: Balugrastim High Dose, Main Phase: Balugrastim Medium Dose, Main Phase: Pegfilgrastim, Pilot Phase: Balugrastim High Dose, Pilot Phase: Balugrastim Low Dose, Pilot Phase: Balugrastim Medium Dose, Pilot Phase: Pegfilgrastim

Primary outcome

Duration of Severe Neutropenia in Cycle 1
Time frame: Cycle 1 (cycle length = 21 days)
Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 x 10^9/liter [L]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10^9/L within the cycle.

3 secondary outcomes

Number of Participants With Febrile Neutropenia
Time frame: Cycles 1 to 4 (each cycle length = 21 days)
Duration of Severe Neutropenia in Cycles 2, 3, and 4
Time frame: Cycles 2, 3, and 4 (each cycle length = 21 days)
Time to Absolute Neutrophil Count (ANC) Recovery in Cycles 1, 2, 3, and 4
Time frame: Cycles 1, 2, 3, and 4

Results and safety

Results posted to the registry on 3 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pilot Phase: Balugrastim Low Dose	11	8
Pilot Phase: Balugrastim Medium Dose	21	18
Pilot Phase: Balugrastim High Dose	20	17
Pilot Phase: Pegfilgrastim	26	22
Main Phase: Balugrastim Medium Dose	0	0
Main Phase: Balugrastim High Dose	0	0
Main Phase: Pegfilgrastim	0	0

Primary outcome: Duration of Severe Neutropenia in Cycle 1

Time frame: Cycle 1 (cycle length = 21 days). Mean (Standard Deviation). Unit: days

Measure	Pilot Phase: Balugrastim Low Dose n = 10	Pilot Phase: Balugrastim Medium Dose n = 21	Pilot Phase: Balugrastim High Dose n = 20	Pilot Phase: Pegfilgrastim n = 25	Main Phase: Balugrastim Medium Dose n = 84	Main Phase: Balugrastim High Dose n = 84	Main Phase: Pegfilgrastim n = 86
Value	0.9 (1.37)	1.6 (1.83)	1.1 (1.48)	0.9 (1.13)	1.0 (1.09)	1.3 (1.22)	1.2 (1.34)

Population analysed: mITT population included all participants who were randomized into the study and received at least 1 dose of assigned study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Balugrastim Low Dose	3 of 10 (30%)	9 of 10 (90%)	Not reported
Balugrastim Medium Dose	11 of 105 (10.5%)	102 of 105 (97.1%)	Not reported
Balugrastim High Dose	9 of 104 (8.7%)	100 of 104 (96.2%)	Not reported
Pegfilgrastim	10 of 112 (8.9%)	105 of 112 (93.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chemotherapy-induced Neutropenia

RecruitingObservational study
Mecapegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Advanced Breast Cancer
Breast Cancer, Chemotherapy-induced Neutropenia
Not yet recruiting
Impact of a Telemonitoring Device on the Occurever at Home in Children at Risk of Chemotherapy-Induced Neutropenia
Oncopediatrics, Febrile Neutropenia
Active, not recruitingPhase 4
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Extensive-stage Small-cell Lung Cancer
Not yet recruitingObservational study
Correlation Between ANC and Bone Pain in Breast Cancer Patients Receiving Long-Acting G-CSF
Breast Cancer, Chemotherapy-Induced Neutropenia
RecruitingPhase 2
Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors
Solid Tumors, Children

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.

Teva Medical Expert, MD study director

Teva Branded Pharmaceutical Products R&D, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Balugrastim, Pegfilgrastim and Chemotherapy Regimen in people with Chemotherapy-induced Neutropenia, run by Teva Branded Pharmaceutical Products R&D, Inc..

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 1 inclusion and 1 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 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

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?

Yes. Results are posted in the registry (first posted 3 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Duration of Severe Neutropenia in Cycle 1 (time frame: Cycle 1 (cycle length = 21 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 NCT00837265.

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 3 Apr 2024.