Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia

Early Stage Breast Cancer Clinical Trial

— REaCT-TC2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816112
• Other study ID #: OTT 16-03
• Status: Completed
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: April 2020

Study information

• Verified date: May 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: April 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Early Stage Breast Cancer
• Febrile Neutropenia
• Neutropenia

Intervention

Drug:
• Ciprofloxacin
Antibiotic
• Neupogen
Granulocyte-colony stimulating factor

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Febrile neutropenia	Number of participants with febrile neutropenia	2 years
Primary	Treatment-related hospitalization	Number of participants admitted to hospital for treatment-related reasons	2 years
Secondary	Chemotherapy dose reduction	Number of participants who receive a dose reduction of their TC chemotherapy	2 years
Secondary	Chemotherapy dose delay	Number of participants who receive a dose delay in their TC chemotherapy	2 years
Secondary	Chemotherapy discontinuation	Number of participants who stop TC chemotherapy for any reason	2 years
Secondary	Microbiologic infections	Number of participants who have a microbiologic infection (i.e: Clostridium difficile)	2 years