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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

September 25, 2020

Primary Completion Date

January 8, 2024

Study Completion Date

November 30, 2025

Conditions
Breast NeoplasmChemotherapy 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."

Trial Locations (10)

Unknown

Rijnstate, Arnhem

Wilhelmina ziekenhuis, Assen

Amphia Ziekenhuis, Breda

Reinier de Graaf Groep, Delft

Deventer ziekenhuis, Deventer

Catharina Ziekenhuis, Eindhoven

MC Leeuwarden, Leeuwarden

MUMC, Maastricht

Erasmus MC, Rotterdam

UMC Utrecht, Utrecht

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Erasmus Medical Center

OTHER

collaborator

UMC Utrecht

OTHER

collaborator

Servier

INDUSTRY

collaborator

BOOG Study Center

OTHER

lead

Borstkanker Onderzoek Groep

NETWORK