Spots Global Cancer Trial Database for Extended-release of Octreotide (LF-PB) for the Treatment of Seroma

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Trial Identification

Brief Title: Extended-release of Octreotide (LF-PB) for the Treatment of Seroma

Official Title: A Multicentre, Double Blind, Randomized Placebo Controlled Trial to Assess the Effect of LF-PB on Seroma Formation in Women With Breast Cancer Undergoing Axillary Lymph Node Dissection

Study ID: NCT02668588

Conditions

Seroma

Interventions

extended release of octreotide

extended release of placebo

Study Description

Brief Summary: This is a multicentre, double blind, randomized placebo controlled trial to assess the effect of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph Node Dissection (ALND). Recruited patients will be randomly assigned to receive LF-PB 30 mg or placebo.

Detailed Description: The study will randomize between 24 and 72 subjects that received an ALND. A staged adaptive design is employed with two intermediate analyses and a final analysis. The first interim analysis at 24 treated subjects (at least 12 in each group) and the second at 48 treated subjects (at least 24 in each group).