A phase 2 open-label study of carboplatin in combination with gemcitabine as a dose-dense schedule in patients with locally advanced or metastatic breast cancer that are resistant to anthracyclines and taxanes

• DOI: 10.12688/f1000research.21804.1
• Publication Date: 2020-01-06T14:00:09Z
• Authors: Christopher Mansb...; Peter Simmonds; Nicholas Murray; Andrew Davies; Louise Stanton; Fay Chinnery; Caroline Archer; Peter Barrett-Lee; Tamas Hickish; Simon Crabb
• Keywords: Taxane; Carboplatin; Clinical endpoint

<ns7:p><ns7:bold>Background: </ns7:bold>Anthracycline- and taxane-based regimens form the mainstay of chemotherapy treatment in metastatic breast cancer. In patients who develop resistance to these agents, management options are limited there is no standard care. Thus, investigation into other chemotherapeutic agents warranted.</ns7:p><ns7:p> <ns7:bold>Methods: </ns7:bold>In this non-randomised prospective trial, with human epidermal growth factor 2 (HER-2)-negative locally advanced or cancer that were anthracycline- taxane-resistant treated carboplatin at a dose equivalent an area under concentration–time curve 4.5 mg/ml.min on day 1 gemcitabine 1500 mg/m<ns7:sup>2 </ns7:sup>on every 2-week cycle. The primary end point was overall response rate.</ns7:p><ns7:p> <ns7:bold>Results: </ns7:bold>A total five enrolled prior early termination due difficulty recruitment. principal reason for recruitment mandating anthracycline taxane pre-treatment HER-2 negativity. One patient had complete response, one partial stable disease two progressive disease. Grade 4 neutropenia occurred patients.</ns7:p><ns7:p> <ns7:bold>Conclusions: population, inclusion criteria too stringent may result difficulties reaching targets. Carboplatin combination appears be safe option Due small sample size, it not possible draw firm conclusions regarding efficacy from trial.</ns7:p><ns7:p> <ns7:bold>Registration: </ns7:bold>EU Clinical Trials Register ID <ns7:ext-link xmlns:ns8="http://www.w3.org/1999/xlink" ext-link-type="uri" ns8:href="https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-005164-83/GB">2005-005164-83</ns7:ext-link>, registered 10 April 2006.</ns7:p>