Jacobs Journal of Internal Medicine

Protocol For A Randomised, Multicentre, Double Blinded Phase III Study Of Perioperative Ketorolac In Women Of African Descent With Operable Breast Cancer

*Osaro Erhabor
Haematology Department, Usmanu Danfodiyo University, Sokoto, Nigeria

*Corresponding Author:
Osaro Erhabor
Haematology Department, Usmanu Danfodiyo University, Sokoto, Nigeria
Email:n_osaro@yahoo.com

Published on: 2018-04-19

Abstract

Cancer remains one of the leading causes of morbidity and mortality worldwide. Breast cancer is the most common form of malignancy occurring in women around the world. The aim of this present protocol is to outline the procedure for a randomised, multicentre, double blinded phase III study of perioperative Ketorolac in Women of African Descent with Operable Breast Cancer. The typical type of breast cancer in sub Saharan Africa is triple negative breast cancer (TNBC) and is usually considered the worst early breast cancer diagnosis since there are no known targeted therapies and patients often relapse and die early. sub-Saharan Africa seems the perfect place to conduct a randomized controlled double blinded clinical trial of perioperative NSAID Romano Demicheli 1, Erhabor Osaro 2, Michael Retsky 3 Forget Patrice 4.Vaidya Jayant S 5. Scientific Directorate Fondazione IRCCS Istituto Nazionale Tumori di Milano Italy 1, Usmanu Danfodiyo University, Sokoto, Nigeria 2, Harvard TH Chan School of Public Health Boston MA USA 3, Department of Anesthesiology, Universite catholique de Louvain, St-Luc Hospital, Av. Hippocrate 10-1821, 1200 Brussels, Belgium 4, University College Hospital, London, UK 5.etorolac to potentially reduce early relapses in breast cancer. The primary and secondary objectives of this trial are to evaluate and compare the Disease Free Survival (DFS) and Overall Survival (OS) of operable breast cancer patients randomised to standard treatment versus standard treatment plus perioperative Ketorolac and to compare the safety and tolerability of the treatment as well as to identify pre- and post-operative factors with prognostic relevance and establish correlations with clinical outcomes. It is anticipated that trial will be successful and would turn TNBC from the worst prognosis to the best and potentially help improve the quality of life of African women suffering from breast cancer.

Keywords

Protocol; Randomised double blinded phase III study; perioperative; Ketorolac; Women; African; Breast Cancer

Introduction

Breast cancer is the most common form of malignancy occurring in women around the world. Each year, more than 200,000 women in the United States are diagnosed with breast cancer and 40,410 women died from the disease in 2006 [1]. In the European Community, an estimated 135,000 new cases per year and 58,000 recorded deaths per year are reported [2]. In sub-Saharan Africa the figures are 94,000 new cases per year and 48,000 deaths per year [3].