TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer — TIBET  

Chemotherapy Effect Clinical Trial

Official title: A Phase 2 Study of Trifluridine/Tipiracil in Patients With ER-positive, HER2-negative Advanced Breast Cancer That Previously Received Chemotherapy

Status Active, not recruiting

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. ;

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Chemotherapy Effect

• NCT number: NCT04489173
• Study type: Interventional
• Source: Borstkanker Onderzoek Groep
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 25, 2020
• Completion date: December 2024