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Clinical Trial Summary

This is a multicenter phase 2 study evaluating the efficacy and safety of trifluridine/tipiracil in women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.


Clinical Trial Description

Multicenter phase 2 study evaluating the efficacy and safety of trifluridine/tipiracil in women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy. This study will be conducted under the sponsorship of BOOG, Amsterdam, NL. Objectives: To evaluate the efficacy of trifluridine/tipiracil by determination of the percentage of patients being progression free at 8 weeks on trifluridine/tipiracil prescribed for ER-positive, HER2-negative advanced breast cancer patients previously treated with a taxane and capecitabine. Endpoints: Progression-free survival Response rate CR/PR at 16 weeks Adverse events Translational research on biological factors that may be of influence on the outcome of treatment QoL Main eligibility criteria: Metastatic Her2 negative, ER-positive breast cancer patients that progressed on, or after treatment with Capecitabine. Previous treatment with Taxanes is obligatory. Adequate hematology, liver and renal function tests. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04489173
Study type Interventional
Source Borstkanker Onderzoek Groep
Contact M.M.E.M. Bos, MD PhD
Phone +31-107034897
Email m.bos@erasmusmc.nl
Status Recruiting
Phase Phase 2
Start date September 25, 2020
Completion date July 2024

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