Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy

Trial Title: Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy

NCT ID: NCT05753618

Condition: Early-stage Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Lenograstim

Conditions: Keywords:
Filgrastim
Pegfilgrastim
Bone pain
Paclitaxel

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Granulocyte Colony-Stimulating Factor (G-CSF)
Description: Participants will receive G-CSF injection (either filgrastim or pegfilgrastim) after each paclitaxel cycle of DD-AC/T chemotherapy.
Arm group label: Receive G-CSF

Other name: Filgrastim

Other name: Pegfilgrastim

Intervention type: Drug
Intervention name: Omission of Granulocyte Colony-Stimulating Factor (G-CSF)
Description: Participants will omit the use of G-CSF (either filgrastim or pegfilgrastim) after each paclitaxel cycle of DD-AC/T chemotherapy
Arm group label: Omission of G-CSF

Summary: 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.

Detailed description: Optimal curative chemotherapy treatment in the early-stage setting for breast cancer patients can reduce the risk of recurrence and result in improvement in breast cancer survival. The pivotal Cancer and Leukemia Group B (CALGB) 9741 clinical trial demonstrated improved efficacy from administering 4 cycles of adriamycin and cyclophosphamide (AC) followed by 4 cycles of paclitaxel using a dose-dense schedule every 2-weeks instead of every 3 weeks in patients with high-risk early-stage breast cancer. It has since become a widely accepted standard care treatment option. Granulocyte colony-stimulating factor (G-CSF) such as filgrastim (FIL) and pegfilgrastim (PEG) are key supportive medications used with the dose-dense regimen to facilitate timely recovery of neutrophil count before the next cycle of treatment. However, G-CSF is associated with increased bone pain after chemotherapy (up to 40%) and drug-induced fever, which can result in additional clinical or emergency room visits. Clinicians have questioned if primary prophylactic G-CSF use is necessary with paclitaxel in the dose-dense regimen and the risk of hematological toxicity, such as the risk of low neutrophils and the risk of infection is lower with paclitaxel. Results from two retrospective studies suggest that it is safe and feasible to omit G-CSF during the paclitaxel portion of the DD-AC/T regimen. Based on the current trial data, there is a stong suggestion that it is safe, feasible and likely preferable to omit G-CSF during the paclitaxel portion of DD-AC/T chemotherapy. Given the majority of chemotherapy dose delays are related to issues such as bone pain (from G-CSF and paclitaxel) and peripheral neuropathy (from paclitaxel), and this may even be exacerbated by the use of G-CSF, it is anticipated that omitting G-CSF during paclitaxel chemotherapy may improve completion rates while improving health related quality of life (HR-QoL). Therefore, the researchers propose a randomized study to further evaluate patient-reported bone pain and HR-QoL from the omission of primary prophylactic G-CSF use during the paclitaxel portion of DD-AC/T chemotherapy while demonstrating supportive evidence that omitting G-CSF is safe and feasible.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: The Ottawa Hospital Cancer Centre

Address:
City: Ottawa
Country: Canada

Status: Recruiting

Contact:
Last name: Lisa Vandermeer, MSc

Phone: 613-737-7700

Phone ext: 70170
Email: lvandermeer@ohri.ca

Start date: April 17, 2023

Completion date: October 2025

Lead sponsor:
Agency: Ottawa Hospital Research Institute
Agency class: Other

Source: Ottawa Hospital Research Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05753618