Clinical Trials Logo
  1. Home
  2. Early-Stage Breast Cancer
  3. NCT02816112

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

Early Stage Breast Cancer Clinical Trial

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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02816112
Study type Interventional
Source Ottawa Hospital Research Institute
Contact
Status Completed
Phase Phase 4
Start date September 2016
Completion date April 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT02816164 - A Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Febrile Neutropenia Phase 4
Completed NCT03946683 - Cyberknife for Early Stage Breast Cancer N/A
Recruiting NCT04458532 - Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer N/A
Completed NCT01162200 - Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer Phase 1
Completed NCT01965522 - Anti-proliferative Effects of Vitamin D and Melatonin in Breast Cancer Phase 2
Completed NCT00309569 - Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients Phase 3
Terminated NCT01545648 - Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer Phase 2
Completed NCT02428114 - A Multi Centre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Standard of Care Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (React-G Study) N/A
Active, not recruiting NCT02685332 - Phase I Dose Escalation of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation Early Stage Breast CA Phase 1
Completed NCT02159157 - A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer N/A
Completed NCT01871116 - POWER-remote Weight Loss Program in Early Stage Breast Cancer N/A
Terminated NCT01166581 - Impact of Breast Magnetic Resonance Imaging (MRI) on Mastectomy Rates N/A
Recruiting NCT06311357 - Percent Weight Change in the Medical Supplement Group of Early Breast Cancer N/A
Terminated NCT02364960 - Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)
Active, not recruiting NCT03561454 - A Registry of Intra-Operative Radiation Therapy (IORT) Using the Xoft ® Axxent ® eBx ™ System Patients
Completed NCT02485678 - A Pragmatic Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer N/A
Active, not recruiting NCT02297672 - Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant N/A
Completed NCT02335671 - Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy N/A
Completed NCT03102307 - Registry Trial to Evaluate the Clinical Utilization of Targeted Axillary Dissection (TAD)
Recruiting NCT04607473 - ABUS for Early-stage Breast Cancer N/A