Recruiting

Paclitaxel

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT05753618

Conditions

Early-stage Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Granulocyte Colony-Stimulating Factor (G-CSF)

Omission of Granulocyte Colony-Stimulating Factor (G-CSF)

Study Details

Brief 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.

Conditions

Early-stage Breast Cancer

Study ID

NCT05753618

Start date

Apr 17, 2023

Status verified date

Jul, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

242 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Receive G-CSF

Receive G-CSF injections (either filgrastim or pegfilgrastim) after each cycle of paclitaxel chemotherapy.

experimental: Omission of G-CSF

Omission of G-CSF injections after each cycle of paclitaxel chemotherapy.

Interventions

Granulocyte Colony-Stimulating Factor (G-CSF)

Participants will receive G-CSF injection (either filgrastim or pegfilgrastim) after each paclitaxel cycle of DD-AC/T chemotherapy.

Omission of Granulocyte Colony-Stimulating Factor (G-CSF)

Participants will omit the use of G-CSF (either filgrastim or pegfilgrastim) after each paclitaxel cycle of DD-AC/T chemotherapy

Primary outcome measure

  • Patient-reported bone pain during cycle 1 of paclitaxel [ Time Frame: At the end of cycle 1 of paclitaxel chemotherapy (each cycle is 14 days) ]

Central Contacts and Locations

Central contacts

Lisa Vandermeer, MSc

613-737-7700lvandermeer@ohri.ca

Carol Stober

613-737-7700cstober@toh.ca

Locations

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Lakeridge Health

Recruiting

Oshawa, Ontario, Canada, L1G 2B9

The Ottawa Hospital Cancer Centre

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Lisa Vandermeer, MSc

613-737-7700lvandermeer@ohri.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Filgrastim
  • Pegfilgrastim
  • Bone pain
  • Paclitaxel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-07-08.