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

Davies, Andrew, Mansbridge, Christopher, Simmonds, Peter, Murray, Nicholas, Stanton, Louise, Chinnery, Fay, Archer, Caroline, Barrett-Lee, Peter, Hickish, Tamas and Crabb, Simon (2020) 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. F1000 Research.

Abstract

Background: 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 and there is no standard of care. Thus, investigation into other chemotherapeutic agents is warranted.
Methods: In this non-randomised prospective trial, patients with human epidermal growth factor 2 (HER-2)-negative locally advanced or metastatic breast cancer that were anthracycline- and taxane-resistant were treated with carboplatin at a dose equivalent to an area under the concentration–time curve of 4.5 mg/ml.min on day 1 and gemcitabine 1500 mg/m2 on day 2 of every 2-week cycle. The primary end point was overall response rate.
Results: A total of five patients were enrolled prior to early termination due to difficulty in recruitment. The principal reason for recruitment difficulty was mandating anthracycline and taxane pre-treatment and HER-2 negativity. One patient had a complete response, one had a partial response, one had stable disease and two had progressive disease. Grade 4 neutropenia occurred in two patients.
Conclusions: In this patient population, inclusion criteria that are too stringent may result in difficulties reaching recruitment targets. Carboplatin in combination with gemcitabine appears to be a safe option for treatment of patients with locally advanced or metastatic breast cancer. Due to the small sample size, it is not possible to draw firm conclusions regarding efficacy from this trial.
Registration: EU Clinical Trials Register ID 2005-005164-83, registered on 10 April 2006

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Contributors

Author: Andrew Davies

Author: Louise Stanton

Author: Fay Chinnery

Author: Simon Crabb

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