This is a trial of up to 6-months duration for safety, tolerability, clinical efficacy assessments, PK and biomarkers analysis in breast carcinoma patients with secondary lymphoedema
This trial will utilize a randomised, double-blinded, placebo controlled design that will assess the safety, tolerability, and secondarily clinical efficacy of LYT-100 over a period of up to 6-months of dosing in breast carcinoma patients with secondary lymphoedema following sentinel lymph node biopsy and/or axillary node dissection, with or without radiation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
BCRL patients will receive LYT-100 BID for 6 months
BCRL patients will receive Placebo BID for 6 months
City of Hope National Medical Center
Duarte, California, United States
MACRO Trials
Los Angeles, California, United States
Accel Research Network
Maitland, Florida, United States
Accel Research Network
Atlanta, Georgia, United States
Safety and Tolerability: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Evaluate the safety and tolerability of LYT-100 as measured by TEAEs
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of the Sunshine Coast
Sippy Downs, Queensland, Australia
Ballarat Health Services
Ballarat, Victoria, Australia
Flinders University
Adelaide, Australia
Macquarie University Health Sciences Centre
Sydney, Australia