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Cytokine

G-CSF Omission for Breast Cancer (REaCT-OGF Trial)

Phase 4

Recruiting

Led By Xinni Song, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

REaCT-OGF Trial Summary

This trial tests if breast cancer patients need to take G-CSF during chemo. Participants are randomly assigned to either take or omit G-CSF.

Who is the study for?

This trial is for early-stage or locally-advanced breast cancer patients who are about to receive DD-AC/T chemotherapy and need drugs to prevent infection due to low white blood cell counts. Participants must be able to consent and complete questionnaires in English or French, but can't join if they have metastatic cancer, past severe reactions to G-CSF, recent chemo within 5 years, or other serious health issues.Check my eligibility

What is being tested?

The study is testing whether it's safe for breast cancer patients on the paclitaxel part of their DD-AC/T chemotherapy regimen to skip taking G-CSF—a drug usually given to boost white blood cells and prevent infections. Patients will either continue with G-CSF as usual or go without it during this phase of treatment.See study design

What are the potential side effects?

G-CSF can cause bone pain, muscle aches, fever-like symptoms, headache, fatigue, skin rash and redness at the injection site. Not using G-CSF might increase the risk of getting an infection due to lower levels of white blood cells.

REaCT-OGF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am getting specific chemotherapy for breast cancer and need medicine to prevent infection.

REaCT-OGF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1 to 5 of the each of the paclitaxel chemotherapy cycles (each cycle is 14 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1 to 5 of the each of the paclitaxel chemotherapy cycles (each cycle is 14 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1 to 5 of the each of the paclitaxel chemotherapy cycles (each cycle is 14 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient-reported bone pain during cycle 1 of paclitaxel

Secondary outcome measures

Cost-effectiveness ratios

Dose-intensity of paclitaxel chemotherapy

Healthcare resource utilization: Emergency Room Visits

+10 more

Side effects data

From 2014 Phase 3 trial • 118 Patients • NCT00003138

31%

Fatigue

23%

Pulmonary

15%

Infection

Cardiac adverse event

Diarrhea

Esophagitis

Hot flashes

Other toxicities

Hemorrhage

Skin

Weight loss

Neuropathy-clinical

Edema

Anemia

Neuropathy-psych

Abdominal cramps

100%

80%

60%

40%

20%

Study treatment Arm

Erythropoietin (300 Units/kg) and Filgrastim (Step 4)

Supportive Care (Step 1)

Erythropoietin (Step 1)

Erythropoietin (Cross-over; Step 2)

Erythropoietin (150 Units/kg) and Filgrastim (Step 3)

REaCT-OGF Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Omission of G-CSFExperimental Treatment1 Intervention

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

Group II: Receive G-CSFActive Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,254 Total Patients Enrolled

35 Trials studying Breast Cancer

5,261 Patients Enrolled for Breast Cancer

Xinni Song, MDPrincipal InvestigatorOttawa Hospital Research Institute

Media Library

Omission of Granulocyte Colony-Stimulating Factor (G-CSF) (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT05753618 — Phase 4

Breast Cancer Research Study Groups: Receive G-CSF, Omission of G-CSF

Breast Cancer Clinical Trial 2023: Omission of Granulocyte Colony-Stimulating Factor (G-CSF) Highlights & Side Effects. Trial Name: NCT05753618 — Phase 4

Omission of Granulocyte Colony-Stimulating Factor (G-CSF) (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05753618 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any possible risks associated with the exclusion of Growth Colony Stimulating Factor?

"The safety of Omission of G-CSF was rated a 3 on our institution's scale, as this is already an approved Phase 4 treatment."

Answered by AI

Are researchers currently seeking participants for this investigation?

"Clinicaltrials.gov does not show that this particular medical study is presently seeking participants, as it was last updated on February 22nd 2023. However, there are over two thousand other clinical trials actively searching for candidates to join their studies at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05753618.