Early-stage Breast CancerPhase 4NCT04781959
A Randomized, Multicenter Pragmatic Trial Comparing Bone Pain From a Single Dose of Pegfilgrastim to 5 Doses of Daily Filgrastim in Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy
A Phase 4 study testing Filgrastim and Pegfilgrastim in people with Early-stage Breast Cancer, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial summary
REaCT-5G will compare bone pain from a single dose of Pegfilgrastim to 5 doses of daily filgrastim in breast cancer patients receiving neoadjuvant/adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early-stage Breast Cancer
- What is being tested?
- Filgrastim and Pegfilgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 2 sitesCanada
- Study dates
- 9 Jun 2021to 28 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with early-stage or locally-advanced breast cancer receiving neoadjuvant or adjuvant chemotherapy requiring primary febrile neutropenia prophylaxis with G-CSF
- Able to provide verbal consent
- Able to complete questionnaires in English or French
Who cannot join
- No access to pegfilgrastim or filgrastim prior to randomization
- Metastatic cancer
- Known hypersensitivity to filgrastim or pegfilgrastim or one of its components
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Ottawa Hospital Research Institute
Ottawa, Ontario
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
About this study
Official title: A Randomized, Multicenter Pragmatic Trial Comparing Bone Pain From a Single Dose of Pegfilgrastim to 5 Doses of Daily Filgrastim in Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy (REaCT-5G)
REaCT-5G will compare bone pain from a single dose of Pegfilgrastim to 5 doses of daily filgrastim in breast cancer patients receiving neoadjuvant/adjuvant chemotherapy.
Read the detailed description
The use of granulocyte colony-stimulating factors (G-CSF) significantly reduces febrile neutropenia (FN) risk and has helped maintain dose intensity and dose density when treating breast cancer with chemotherapy. This is crucial as survival outcomes are significantly impaired if dose intensity are reduced. National and international guidelines recommend the use of G-CSF as primary prophylaxis with most commonly used breast cancer chemotherapy regimens. Filgrastim (FIL) as a G-CSF that has been in use since the early 90s. Pegfilgrastim (PEG) is a long-acting, pegylated version of FIL that requires only one injection per chemotherapy cycle instead of daily FIL injections for 5 to 10 days per cycle. PEG and FIL both come at the potential cost of bone pain, the most common side effect. G-CSF related bone pain is often severe, leading to refusal or cancellation of G-CSF and early discontinuation of chemotherapy. We propose to perform a pragmatic, multicenter, open-label, randomized clinical trial to compare bone pain experienced by patients receiving either PEG or 5-day-FIL with neoadjuvant or adjuvant chemotherapy.
- Conditions
- Early-stage Breast Cancer
- Being tested
- Filgrastim, Pegfilgrastim
- Keywords
- Filgrastim, 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.
FilgrastimDrug
Also called Neupogen
Receive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy
PegfilgrastimDrug
Also called Neulasta
Receive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 5 Days of Filgrastim | Active comparator | Receive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy. Receives: Drug: Filgrastim |
| Pegfilgrastim | Active comparator | Receive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy Receives: Drug: Pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone pain
Bone pain over the first 5 days after the administration of G-CSF. The total measure of bone pain over the five days will be summarized by the area under the curve (AUC) based on a patient's daily pain score, starting after the first dose of G-CSF injection.
Measured: 5 days after first G-CSF injection
Secondary outcomes (10)
Incidence of Febrile Neutropenia
Number of times participants have Febrile neutropenia during chemotherapy treatment
Measured: 2.5 years after study initiation
Incidence of treatment-related hospitalizations
Number of times participants have a treatment-related hospitalization
Measured: 2.5 years after study initiation
Incidence of chemotherapy alteration
Number of times participants have a chemotherapy alteration including: dose delay, reduction and/or discontinuation
Measured: 2.5 years after study initiation
Incidence of chemotherapy-related mortality
Number of times there is a chemotherapy-related mortality
Measured: 2.5 years after study initiation
Rate of G-CSF compliance as prescribed
Number of times there is a G-CSF compliance
Measured: 2.5 years after study initiation
Differences in healthcare resource utilization
Differences in healthcare resource utilization: number of emergency room visits, number of planned/unplanned provider clinic visits (including stretcher bay), patient-reported phone calls or email to patient support line or provider, and additional medication use or management strategies related to G-CSF side effects or efficacy
Measured: 2.5 years after study initiation
HR-QoL
HR-QoL based on EQ-5D-5L
Measured: 2.5 years after study initiation
Cost-effectiveness
Cost differences associated with prescribing Filgrastim and Pegfilgrastim
Measured: 2.5 years after study initiation
Patient G-CSF preference
To survey patient preference in selection of G-CSF treatment before and after undergoing chemotherapy and G-CSF treatment
Measured: 2.5 years after study initiation
Study feasibility
Interim analysis/feasibility. After the first year of study initiation, if study recruitment is less than 30% at one year (70 patients), or if there are unanticipated safety issues, a review of study conduct will be performed to consider stopping the study unless there are unexpected or exceptional reasons, or in the case of low recruitment, there is a plan to boost recruitment efforts
Measured: 1 year after study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start9 Jun 2021
- Primary completion23 Feb 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terry Ng, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781959
- Sponsor's protocol ID
- REaCT-5G
- Status last verified
- Mar 2025
- First submitted
- 1 Mar 2021
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter Pragmatic Trial Comparing Bone Pain From a Single Dose of Pegfilgrastim to 5 Doses of Daily Filgrastim in Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy (REaCT-5G)
- ClinicalTrials.gov ID
- NCT04781959
- Acronym / sponsor ID
- REaCT-5G
- Conditions
- Early-stage Breast Cancer
- Keywords
- Filgrastim, Pegfilgrastim
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 4 Mar 2021 (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.
REaCT-5G will compare bone pain from a single dose of Pegfilgrastim to 5 doses of daily filgrastim in breast cancer patients receiving neoadjuvant/adjuvant chemotherapy.
Detailed description
The use of granulocyte colony-stimulating factors (G-CSF) significantly reduces febrile neutropenia (FN) risk and has helped maintain dose intensity and dose density when treating breast cancer with chemotherapy. This is crucial as survival outcomes are significantly impaired if dose intensity are reduced. National and international guidelines recommend the use of G-CSF as primary prophylaxis with most commonly used breast cancer chemotherapy regimens. Filgrastim (FIL) as a G-CSF that has been in use since the early 90s. Pegfilgrastim (PEG) is a long-acting, pegylated version of FIL that requires only one injection per chemotherapy cycle instead of daily FIL injections for 5 to 10 days per cycle. PEG and FIL both come at the potential cost of bone pain, the most common side effect. G-CSF related bone pain is often severe, leading to refusal or cancellation of G-CSF and early discontinuation of chemotherapy. We propose to perform a pragmatic, multicenter, open-label, randomized clinical trial to compare bone pain experienced by patients receiving either PEG or 5-day-FIL with neoadjuvant or adjuvant chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 Days of Filgrastim | Active comparator | Drug: FilgrastimReceive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy. |
| Pegfilgrastim | Active comparator | Drug: PegfilgrastimReceive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with early-stage or locally-advanced breast cancer receiving neoadjuvant or adjuvant chemotherapy requiring primary febrile neutropenia prophylaxis with G-CSF
- Able to provide verbal consent
- Able to complete questionnaires in English or French
Key exclusion criteria (3 listed)
- No access to pegfilgrastim or filgrastim prior to randomization
- Metastatic cancer
- Known hypersensitivity to filgrastim or pegfilgrastim or one of its components
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 |
|---|---|---|
| FilgrastimAlso: NeupogenReceive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy | Drug | 5 Days of Filgrastim |
| PegfilgrastimAlso: NeulastaReceive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy | Drug | Pegfilgrastim |
Primary outcome
Bone pain
Time frame: 5 days after first G-CSF injection
Bone pain over the first 5 days after the administration of G-CSF. The total measure of bone pain over the five days will be summarized by the area under the curve (AUC) based on a patient's daily pain score, starting after the first dose of G-CSF injection.
10 secondary outcomes
Incidence of Febrile Neutropenia
Time frame: 2.5 years after study initiation
Incidence of treatment-related hospitalizations
Time frame: 2.5 years after study initiation
Incidence of chemotherapy alteration
Time frame: 2.5 years after study initiation
Incidence of chemotherapy-related mortality
Time frame: 2.5 years after study initiation
Rate of G-CSF compliance as prescribed
Time frame: 2.5 years after study initiation
Differences in healthcare resource utilization
Time frame: 2.5 years after study initiation
HR-QoL
Time frame: 2.5 years after study initiation
Cost-effectiveness
Time frame: 2.5 years after study initiation
Patient G-CSF preference
Time frame: 2.5 years after study initiation
Study feasibility
Time frame: 1 year after study initiation
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 21 Mar 2025.
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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.
Terry Ng, MD principal investigator
Ottawa Hospital Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Filgrastim and Pegfilgrastim in people with Early-stage Breast Cancer, run by Ottawa Hospital Research Institute at 2 sites in Canada.
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 3 inclusion and 3 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
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?
Bone pain (time frame: 5 days after first G-CSF injection). 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 21 Mar 2025; AzTrials last refreshed its copy on 29 Oct 2026.