Evaluation of the Effects of Pasireotide LAR Administration on Lymphocele Prevention after Axillary Node Dissection for Breast Cancer: Results of a Randomized Non-Comparative Phase 2 Study.

ABSTRACT:

Objective

The aim of this study was to assess the efficacy (response rate centered on 80%) of a somatostatin analog with high affinity for 4 somatostatin receptors in reducing the postoperative incidence of symptomatic lymphocele formation following total mastectomy with axillary lymph node dissection.

Setting

This prospective, double-blind, randomised, placebo-controlled, phase 2 trial was conducted in two secondary care centres.

Participants

All female patients for whom mastectomy and axillary lymph node dissection were indicated were eligible for the study, including patients who had received neo-adjuvant chemotherapy. Main exclusion criteria were related to diabetes, cardiac insufficiency, disorder of cardiac conduction or hepatic failure.

Interventions

Pat

SUBMITTER: Chereau E 

PROVIDER: S-EPMC4900597 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature