Clinical trial · Interventional
Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy
A Randomized Pragmatic Trial Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy (REaCT-OGF)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this randomized, pragmatic clinical trial is to evaluate the omission of granulocyte colony-stimulating factors (G-CSF) in breast cancer patients receiving paclitaxel portion of dose-dense adriamycin-cyclophosphamide and paclitaxel (DD-AC/T) chemotherapy. Participants will be randomized to either take G-CSF while on the paclitaxel portion of DD-AC/T chemotherapy or to omit G-CSF while on the paclitaxel portion of DD-AC/T chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Granulocyte Colony-Stimulating Factor (G-CSF) | Drug | — | UNRESOLVED |
| Omission of Granulocyte Colony-Stimulating Factor (G-CSF) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Receive G-CSF
- description
- Receive G-CSF injections (either filgrastim or pegfilgrastim) after each cycle of paclitaxel chemotherapy.
- interventionNames
- Drug: Granulocyte Colony-Stimulating Factor (G-CSF)
- type
- EXPERIMENTAL
- label
- Omission of G-CSF
- description
- Omission of G-CSF injections after each cycle of paclitaxel chemotherapy.
- interventionNames
- Drug: Omission of Granulocyte Colony-Stimulating Factor (G-CSF)
Primary outcomes (1)
- measure
- Patient-reported bone pain during cycle 1 of paclitaxel
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with early-stage or locally-advanced breast cancer receiving neoadjuvant or adjuvant DD-AC/T chemotherapy requiring primary febrile neutropenia prophylaxis with G-CSF * Able to provide verbal consent * Able to complete questionnaires in English or French Exclusion Criteria: * No access to pegfilgrastim or filgrastim prior to randomization * Metastatic cancer * Known hypersensitivity to filgrastim or pegfilgrastim or one of its components * Patients received prior cytotoxic chemotherapy within the last 5 years * Patients with uncontrolled inter-current illness that would limit compliance with study requirements or other significant diseases or disorders that, in the investigator's opinion, would exclude the subject from participating in the study
References
Publications (0)
Data not yet available