Lymphorrhea Clinical Trial
Official title:
A Randomized, Double-Blind, Double Dummy, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of LF-PB 10 mg, 20 mg, and 30 mg to Treat Lymphorrhea Post Axillary Dissection in Breast Cancer
This is a phase II, multicenter, double-blind, double-dummy, parallel-group,
placebo-controlled, study to evaluate LF-PB versus placebo in female patients with brest
cancer who are undergoing breast surgery with axillary lymphnode dissection.
Recruited patients will be randomly assigned to one of the following treatment groups:
Placebo, LF-PB 10 mg, LF-PB 20 mg and LF-PB 30 mg.
Mode of administration is single intramuscular (IM) injection so the treatments arms are as
follows:
Placebo: 2 injections of placebo LF-PB 10 mg: 2 injections = placebo + 10 mg LF-PB 20 mg: 2
injections = placebo + 20 mg LF-PB 30 mg: 2 injections = 10 mg + 20 mg
The study will randomize a total of 120 patients (30 per arm) in about 10 Italian Sites.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment