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Association between pertuzumab induced diarrhea and cutaneous rash and survival outcomes in patients with HER2-positive metastatic breast cancer enrolled in the CLEOPATRA trial








Association between pertuzumab induced diarrhea and cutaneous rash and survival outcomes in patients with HER2-positive metastatic breast cancer enrolled in the CLEOPATRA trial


Evandro de Azambuja


Institut Jules Bordet


None




28 Jan 2019


Breast cancer is a common and deadly disease. One of the most common problems faced by patients and physicians during treatment of breast cancer is the difficulty of knowing, at an early point in treatment, whether a particular treatment is helping a patient or not. This very often leads to patients receiving treatment that do not help them. To avoid this, a lot of research is today performed in order to discover different forms of predicting whether a patient will benefit from specific treatments. Recently, one such predictor was identified for a drug used against breast cancer called lapatinib. Women who receive lapatinib to treat breast cancer and whom during treatment experience a skin rash have a higher chance of benefitting from treatment than women who do not experience a skin rash. Thus, in medical terms skin rash for patients receiving lapatinib is a predictor of benefit from treatment.Pertuzumab is a drug approved by authorities for use in certain breast cancer cases, similarly to lapatinib. As these drugs kill cancer cells by targeting the same molecule, our research project will test the hypothesis that skin rash works as a predictor of pertuzumab benefitting patients when they who receive it to treat their breast cancer. Since diarrhoea is also a common side effect of pertuzumab, we also aim to evaluate whether patients who experience diarrhoea benefit more from pertuzumab treatment than those who do not. The CLEOPATRA study is the most important study conducted thus far with pertuzumab in patients with breast cancer. We intend to use data from this study to test our hypothesis.



[{ "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" }]

Statistical Analysis Plan