Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia (REaCT-TC2)

A Multi-Centre Study to Compare Granulocyte-colony Stimulating Factors to Antibiotics for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induced Febrile Neutropenia REaCT-TC2

Taxotere-cyclophosphamide (TC) chemotherapy is commonly used as an adjuvant chemotherapy regimen in patients with resected early stage breast cancer. TC chemotherapy can cause febrile neutropenia (FN) which can be serious and associated with treatment delays and dose reductions, thereby compromising treatment efficacy. To reduce the risk of chemotherapy-induced FN,TC is administered with either one of two highly effective standard treatments; namely primary prophylaxis with either ciprofloxacin or granulocyte colony-stimulating factor (G-CSF). However, there are considerable cost differences between these strategies; subcutaneous daily G-CSF costs at least $12,000 over 4 cycles of treatment while oral ciprofloxacin costs about $100.

The investigators have therefore been performing a feasibility study to explore whether the "integrated consent model" involving oral consent is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials. This feasibility study (REaCT-TC NCT02173262) has been an amazing success and the investigators are therefore now performing a definitive study comparing G-CSF with ciprofloxacin. This study will not be evaluating feasibility endpoints, but rather clinically important endpoints of hospitalizations and febrile neutropenia rates.

Study Overview

• Status: Completed
• Conditions: Early Stage Breast Cancer
• Intervention / Treatment: Drug: Ciprofloxacin; Drug: Neupogen

• Study Type: Interventional
• Enrollment (Actual): 458
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • The Ottawa Hospital Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically confirmed primary breast cancer
• Planned TC chemotherapy
• ≥19 years of age
• Able to provide verbal consent

Exclusion Criteria:

• Contraindication to either Ciprofloxacin or G-CSF

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ciprofloxacin; Oral tablet taken twice a day at home starting 5 days after chemotherapy for 14 days for every cycle of TC	Drug: Ciprofloxacin; Antibiotic
Active Comparator: G-CSF; Daily injection at home for the number of days as chosen by the treating physician	Drug: Neupogen; Granulocyte-colony stimulating factor; Other Names: filgrastim

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Febrile neutropenia	Number of participants with febrile neutropenia	2 years
Treatment-related hospitalization	Number of participants admitted to hospital for treatment-related reasons	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chemotherapy dose reduction	Number of participants who receive a dose reduction of their TC chemotherapy	2 years
Chemotherapy dose delay	Number of participants who receive a dose delay in their TC chemotherapy	2 years
Chemotherapy discontinuation	Number of participants who stop TC chemotherapy for any reason	2 years
Microbiologic infections	Number of participants who have a microbiologic infection (i.e: Clostridium difficile)	2 years

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Mark Clemons, MD, The Ottawa Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: June 24, 2016
• First Submitted That Met QC Criteria: June 27, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia; Febrile Neutropenia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: OTT 16-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make IDP available.