What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as dose-dense adriamycin-cyclophosphamide and paclitaxel (DD-AC/T), often lead to side effects including neutropenia (low white blood cell count), anemia, thrombocytopenia (low platelet count), nausea, vomiting, hair loss, fatigue, and increased risk of infections. The use of granulocyte colony-stimulating factors (G-CSF) helps to reduce the incidence of neutropenia but can cause bone pain, fever, and injection site reactions. These treatments aim to balance efficacy in cancer control with the management of these side effects.

What prior FDA approvals exist?

The FDA has approved several granulocyte colony-stimulating factors (G-CSF) for the management of chemotherapy-induced neutropenia in breast cancer patients. Notable drugs include filgrastim (Neupogen), pegfilgrastim (Neulasta), and tbo-filgrastim (Granix). These agents are used to stimulate the bone marrow to produce white blood cells, thereby reducing the risk of infection during chemotherapy. The trial on the omission of G-CSF in breast cancer patients receiving paclitaxel as part of dose-dense adriamycin-cyclophosphamide and paclitaxel (DD-AC/T) chemotherapy aims to evaluate the necessity of these agents in this specific treatment regimen.

What other types of research exist?

Promising novel alternatives to the omission of G-CSF for breast cancer patients include the use of long-acting granulocyte colony-stimulating factors such as pegfilgrastim and lipegfilgrastim, which have shown efficacy in reducing chemotherapy-induced neutropenia. Additionally, the use of biosimilars to G-CSF, which are more cost-effective, and the integration of novel agents like trilaciclib, a CDK4/6 inhibitor that protects bone marrow from chemotherapy-induced damage, are also promising options. These alternatives aim to maintain white blood cell counts and reduce the risk of infections during chemotherapy.

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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 below

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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:

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I have had chemotherapy in the past 5 years.

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I have not used pegfilgrastim or filgrastim before joining this study.

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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)

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

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 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)

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.

0 / 4Eligibility criteria met

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.