NCT04489173

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Borstkanker Onderzoek Groep · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 at 8 weeks. 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.

Conditions

• Breast Neoplasm
• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	trifluridine/tipiracil	Study medication should be started within 3 days after completion of screening and continue until a study treatment discontinuation criterion is met. Trifluridine/tipiracil will be administered orally BID on days 1 through 5, with the first dose administered in the morning of day 1 of each cycle and the last dose administered in the evening of day 5, followed by a recovery period from day 6 through day 7. Trifluridine/tipiracil will be administered orally BID on days 8 through 12, with the first dose administered in the morning of day 8 of each cycle and the last dose administered in the evening of day 12, followed by a recovery period from day 13 through day 28. Each cycle will be 28 days.

Timeline

• Start date: 2020-09-25
• Primary completion: 2024-01-08
• Completion: 2025-11-01
• First posted: 2020-07-28
• Last updated: 2025-09-19

Locations

10 sites across 1 country: Netherlands