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A study to identify the associated factor of reported adverse event severity among HER2-positive metastatic breast cancer patient from clinical trials.

A study to identify the associated factor of reported adverse event severity among HER2-positive metastatic breast cancer patient from clinical trials.


Centre for Investigational New Product, National Pharmaceutical Regulatory Agency (NPRA)Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia


28 Jan 2019

An adverse event is a public health problem with a significant increase in the complication and the cost of healthcare. The incidence of the adverse event among trial subject in breast cancer clinical trial is high and what more worrying is the subject may suffer a number of severe complication from an adverse event. However, very few data are available on the incidence and risk factors associated with higher severity of adverse event development in patients with HER2-positive breast cancer which tend to be more aggressive.RIBBON 1, 2, LUX-BREAST 1, CLEOPATRA and EMILIA are the large global phase 3 randomised placebo-controlled multicentre studies of HER2-positive breast cancer. All studies evaluated the ability of a novel molecule targeted therapy, to improve the patients' overall survival or progression-free survival. Therefore, we propose that data from these studies would allow conducting a comprehensive and overall assessment regarding the incidence and associated factors of adverse event severity during the treatment period among these patients. I am an MSc student in medical statistic and research methodology at the Universiti Sains Malaysia and propose to conduct this research as my dissertation. The study participants will be around 3,511 subjects who were participating in multiple breast cancer clinical trials sponsored by different pharmaceutical company. To determine the associated factor of adverse event severity in this subset of patients, multiple variable ordinal regression models with various assumption checking will be applied. Potential risk factors analyzed will depend on the available of data collected in the requested study; however, based on literature review, we propose the variable to be studied may include but not limited to: demographic factors (age, gender, race, smoking status, height, weight, BMI, region), treatment factors (chemotherapy, radiotherapy, molecule targeted therapy, number of concomitant medications), co-morbidity factors ( hypertension, diabetes mellitus, hyperlipidemia, heart disease, stroke, clinical parameters (glycemic control, renal profile, lipid profile, cancer marker profile), HER2-positive cancer characteristics (family history, disease duration since diagnosis, hormone receptor status, tumor staging, number of lymph node, tumor size, vascular invasion) The availability of this result will permit enhancing the quality of management of patients with such characteristics in daily practice. In detail, they will enable to establish a more careful strategy in the quality of management of patient safety profile.The findings will be interpreted within the limits of research and will be communicated by presentations at national or international conferences. A peer reviewed publication will be submitted summarizing the results as well.

[{ "PostingID": 1310, "Title": "ROCHE-AVF3694G", "Description": "A multicenter, phase III, randomized, placebo-controlled trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy regimens in subjects with previously untreated metastatic breast cancer" },{ "PostingID": 1340, "Title": "ROCHE-WO20698 (CLEOPATRA)", "Description": "A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Herceptin + docetaxel + pertuzumab versus Herceptin + docetaxel + placebo in previously untreated HER2-positive metastatic breast cancer" },{ "PostingID": 2549, "Title": "ROCHE-AVF3693G", "Description": "A Phase III, Multicenter, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Treated Metastatic Breast Cancer" },{ "PostingID": 2574, "Title": "ROCHE-BO21977", "Description": "A randomized, Multicenter, Phase III Open-Label study of the efficacy and safety of Trastuzumab-MCC-DM1 vs. Capecitabine + Lapatinib in patients with HER2-Positive locally advanced or metastic breast cancer who have received prior Trastuzumab-based therapy." }]

Statistical Analysis Plan