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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 Days of Filgrastim | Active Comparator | Receive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy. |
|
| Pegfilgrastim | Active Comparator | Receive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgrastim | Drug | Receive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 days after first G-CSF injection |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Febrile Neutropenia | Number of times participants have Febrile neutropenia during chemotherapy treatment | 2.5 years after study initiation |
| Incidence of treatment-related hospitalizations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terry Ng, MD | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Hospital Research Institute | Ottawa | Ontario | Canada | |||
| Thunder Bay Regional Health Sciences Centre |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 14, 2025 | |
| Reset | Nov 25, 2025 |
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| Pegfilgrastim | Drug | Receive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy |
|
|
Number of times participants have a treatment-related hospitalization
| 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 | 2.5 years after study initiation |
| Incidence of chemotherapy-related mortality | Number of times there is a chemotherapy-related mortality | 2.5 years after study initiation |
| Rate of G-CSF compliance as prescribed | Number of times there is a G-CSF compliance | 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 | 2.5 years after study initiation |
| HR-QoL | HR-QoL based on EQ-5D-5L | 2.5 years after study initiation |
| Cost-effectiveness | Cost differences associated with prescribing Filgrastim and Pegfilgrastim | 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 | 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 | 1 year after study initiation |
| Thunder Bay |
| Ontario |
| P7B 6V4 |
| Canada |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 14, 2025 | Nov 25, 2025 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| C455861 | pegfilgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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