Clinical Trials Logo

Clinical Trial Summary

REaCT-5G will compare bone pain from a single dose of Pegfilgrastim to 5 doses of daily filgrastim in breast cancer patients receiving neoadjuvant/adjuvant chemotherapy.


Clinical Trial Description

The use of granulocyte colony-stimulating factors (G-CSF) significantly reduces febrile neutropenia (FN) risk and has helped maintain dose intensity and dose density when treating breast cancer with chemotherapy. This is crucial as survival outcomes are significantly impaired if dose intensity are reduced. National and international guidelines recommend the use of G-CSF as primary prophylaxis with most commonly used breast cancer chemotherapy regimens. Filgrastim (FIL) as a G-CSF that has been in use since the early 90s. Pegfilgrastim (PEG) is a long-acting, pegylated version of FIL that requires only one injection per chemotherapy cycle instead of daily FIL injections for 5 to 10 days per cycle. PEG and FIL both come at the potential cost of bone pain, the most common side effect. G-CSF related bone pain is often severe, leading to refusal or cancellation of G-CSF and early discontinuation of chemotherapy. We propose to perform a pragmatic, multicenter, open-label, randomized clinical trial to compare bone pain experienced by patients receiving either PEG or 5-day-FIL with neoadjuvant or adjuvant chemotherapy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04781959
Study type Interventional
Source Ottawa Hospital Research Institute
Contact
Status Active, not recruiting
Phase Phase 4
Start date June 9, 2021
Completion date December 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05528263 - Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial) N/A
Completed NCT00165243 - Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer Phase 2
Recruiting NCT05559164 - Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Phase 2
Completed NCT03948568 - Evaluating Optimal Timing of Endocrine Therapy and Radiation Therapy in Early-stage Breast Cancer (REaCT-RETT) Phase 4
Recruiting NCT04553770 - Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer Phase 2
Recruiting NCT06001762 - TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer Phase 2
Active, not recruiting NCT03664687 - Comparing a Single-Dose vs. Twice Yearly Zoledronate in Patients With Early Stage Breast Cancer (REaCT-ZOL) Phase 4
Recruiting NCT04603209 - Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer
Completed NCT00233077 - Patient Centered Randomized Controlled Trial N/A
Recruiting NCT02958033 - Shandong Cancer Hospital Affiliated to Shandong University Phase 3
Recruiting NCT03788083 - Intratumoral TriMix Injections in Early Breast Cancer Patients Phase 1
Recruiting NCT03797248 - Prospective Cohort Study of Traditional Chinese Medicine for Survival of Patients With Early Breast Cancer
Recruiting NCT05582499 - Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy Phase 1/Phase 2
Recruiting NCT05871437 - Huaier Granule on Reducing the Level of Tumor Markers in Patients With Early-stage Breast Cancer Phase 4
Recruiting NCT04003558 - Deep Learning Algorithms for Prediction of Lymph Node Metastasis and Prognosis in Breast Cancer MRI Radiomics (RBC-01)
Terminated NCT03894007 - Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer Phase 2
Recruiting NCT02982148 - Methylene Blue Intradermal Injection for Sentinel Lymph Node Biopsy for Breast Cancer Patients Phase 4
Active, not recruiting NCT03553797 - Accelerated Whole Breast Irradiation Hypofractionation Plus Boost VS Standard Whole Breast Irradiation Plus Boost Phase 3
Recruiting NCT06215469 - Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads) N/A
Enrolling by invitation NCT06409221 - VISION: Triple Negative Breast Cancer Sample and Clinical Data Acquisition Study