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

NCT02816112 | Completed Phase 4

• 1 other identifier: OTT 16-03
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early Stage Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Chemotherapy dose reduction

  2 years

• Chemotherapy dose delay

  2 years

• Chemotherapy discontinuation

  2 years

• Microbiologic infections

  2 years

Study Arms (2)

Ciprofloxacin

ACTIVE COMPARATOR

Oral tablet taken twice a day at home starting 5 days after chemotherapy for 14 days for every cycle of TC

Drug: Ciprofloxacin

G-CSF

ACTIVE COMPARATOR

Daily injection at home for the number of days as chosen by the treating physician

Drug: Neupogen

Interventions

Ciprofloxacin DRUG

Antibiotic

Ciprofloxacin

Neupogen DRUG

Granulocyte-colony stimulating factor

Also known as: filgrastim

G-CSF

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Contraindication to either Ciprofloxacin or G-CSF

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Location

MeSH Terms

Interventions

Ciprofloxacin; Filgrastim

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Mark Clemons, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 28, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)