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

NCT05753618 | Recruiting Phase 4

• 1 other identifier: REaCT-OGF
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 3

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

Keywords

Filgrastim; Pegfilgrastim; Bone pain; Paclitaxel

Outcome Measures

Primary Outcomes (1)

• Patient-reported bone pain during cycle 1 of paclitaxel

  The primary outcome is patient-reported bone pain from day 1 to 5 during cycle 1 of paclitaxel chemotherapy. The total measure of bone pain over the five days will be summarized by the area under the curve (AUC) using the trapezoidal quadrature method for patients reported daily pain score from day 1 to 5 during cycle 1 of paclitaxel chemotherapy. Day 1 being the morning after first dose of G-CSF injection, or 48 hours after chemotherapy injection in the No G-CSF arm. The daily pain score ranges from 0-40. Peak pain is defined as the maximum pain rating over day 1 to day 5. To reiterate the scoring system, every morning, patients are asked to rate the most severe pain they experienced in the last 24 hours on a visual analogue scale (VAS) from 0 (no pain) to 10 (pain as bad as you can imagine). The X axis of the AUC represents time (i.e., days) and the Y axis represents pain severity (0-10).

  At the end of cycle 1 of paclitaxel chemotherapy (each cycle is 14 days)

Secondary Outcomes (13)

• Patient-reported bone pain across all paclitaxel cycles

  After each of the paclitaxel chemotherapy cycles (each cycle is 14 days)

• Peak bone pain experienced

  Days 1 to 5 of the each of the paclitaxel chemotherapy cycles (each cycle is 14 days)

• Patient health-related quality of life

  Through study completion, average of 12 weeks

• Rates of completion of 4 cycles of paclitaxel

  Through study completion, average of 12 weeks

• Dose-intensity of paclitaxel chemotherapy

  Through study completion, average of 12 weeks

Study Arms (2)

Receive G-CSF

ACTIVE COMPARATOR

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

Drug: Granulocyte Colony-Stimulating Factor (G-CSF)

Omission of G-CSF

EXPERIMENTAL

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

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

Interventions

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

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

Omission of G-CSF

Granulocyte Colony-Stimulating Factor (G-CSF) DRUG

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

Also known as: Filgrastim, Pegfilgrastim

Receive G-CSF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (3)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

Lakeridge Health

Oshawa, Ontario, L1G 2B9, Canada

RECRUITING

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Related Links

• The Rethinking Clinical Trials (REaCT) website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim; pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Xinni Song, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Vandermeer, MSc

CONTACT

613-737-7700; lvandermeer@ohri.ca

Carol Stober

CONTACT

613-737-7700; cstober@toh.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: March 3, 2023
• Study Start: April 17, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

CA (3)