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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
Must not have
Patients received prior cytotoxic chemotherapy within the last 5 years
No access to pegfilgrastim or filgrastim prior to randomization
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
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial is testing whether breast cancer patients can safely skip a medication during part of their chemotherapy. This medication helps with white blood cell recovery but can cause painful side effects. The study aims to see if omitting this medication can improve patients' quality of life without increasing infection risks.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am getting specific chemotherapy for breast cancer and need medicine to prevent infection.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had chemotherapy in the past 5 years.
Select...
I have not used pegfilgrastim or filgrastim before joining this study.
Select...
My cancer has spread to other parts of my body.
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patient-reported bone pain during cycle 1 of paclitaxel
Secondary study objectives
Cost-effectiveness ratios
Dose-intensity of paclitaxel chemotherapy
Healthcare resource utilization: Emergency Room Visits
+10 moreSide effects data
From 2014 Phase 3 trial • 118 Patients • NCT0000313831%
Fatigue
23%
Pulmonary
15%
Infection
8%
Cardiac adverse event
8%
Diarrhea
8%
Esophagitis
8%
Hot flashes
8%
Other toxicities
8%
Hemorrhage
8%
Skin
8%
Weight loss
8%
Neuropathy-clinical
8%
Edema
8%
Anemia
8%
Neuropathy-psych
8%
Abdominal cramps
100%
80%
60%
40%
20%
0%
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)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for breast cancer, such as paclitaxel and adriamycin-cyclophosphamide, work by targeting rapidly dividing cancer cells. Paclitaxel stabilizes microtubules, preventing cell division, while adriamycin intercalates DNA and inhibits topoisomerase II, leading to DNA damage and cell death.
Cyclophosphamide adds alkyl groups to DNA, causing cross-linking and apoptosis. These mechanisms are crucial for effectively reducing tumor size and preventing metastasis.
However, they also affect rapidly dividing healthy cells, leading to side effects like neutropenia. Granulocyte Colony-Stimulating Factors (G-CSF) are often used to mitigate this by stimulating bone marrow to produce white blood cells, reducing infection risk and allowing patients to maintain their chemotherapy schedule.
Find a Location
Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
576 Previous Clinical Trials
3,139,688 Total Patients Enrolled
35 Trials studying Breast Cancer
5,270 Patients Enrolled for Breast Cancer
Xinni Song, MDPrincipal InvestigatorOttawa Hospital Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to filgrastim or pegfilgrastim.I can complete questionnaires in English or French.I have had chemotherapy in the past 5 years.I am getting specific chemotherapy for breast cancer and need medicine to prevent infection.I have not used pegfilgrastim or filgrastim before joining this study.My cancer has spread to other parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Receive G-CSF
- Group 2: Omission of G-CSF
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.