MedTrace Logo

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

NCT04489173 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Breast Neoplasm
  • Chemotherapy Effect

Interventions

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.

Sponsors & Collaborators

  • Erasmus Medical Center

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • Servier

    collaborator INDUSTRY

  • BOOG Study Center

    collaborator OTHER

  • Borstkanker Onderzoek Groep

    lead NETWORK

Principal Investigators

  • A. Elise van Leeuwen-Stok, PhD · BOOG Study Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-25
Primary Completion
2024-01-08
Completion
2026-05-19

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04489173 on ClinicalTrials.gov