A Study of Trifluridine/Tipiracil in Triple Negative Metastatic Breast Cancer — TACTIC  

Metastatic Triple Negative Breast Cancer Clinical Trial

Official title: A Phase 2 Study of Trifluridine/Tipiracil in Triple Negative Metastatic Breast Cancer

Status Withdrawn

Clinical Trial Summary

This is an open-label, single arm, multi-stage, phase II trial of Trifluridine/tipiracil as a palliative treatment for patients with metastatic triple negative breast cancer who have failed both a taxane and anthracycline or have contraindications to these agents.

Clinical Trial Description

This is an open-label, single arm, multi-stage, phase II trial of Trifluridine/tipiracil (TAS-102) as a palliative treatment for patients with metastatic triple negative breast cancer who have failed both a taxane and anthracycline or have contraindications to these agents.

The trial will begin with a safety run-in of 10 patients treated as follows:

Cycle 1: Trifluridine/tipiracil administered at 30 mg/m2 orally bid, 5 days per week, with 2 days of rest, for 2 weeks, followed by 14 day rest. Intra-patient dose escalation to 35 mg/m2 orally bid, 5 days per week, with 2 days of rest, for 2 weeks, followed by 14 day rest for subsequent cycles in the absence of dose limiting toxicities. As long as at least 80% of patients tolerate dose escalation, the trial will proceed to the next stage.

Patients enrolled in stages I and II will start Trifluridine/tipiracil at 35 mg/m2 orally bid, 5 days per week, with 2 days of rest, for 2 weeks, followed by 14 day rest. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

• NCT number: NCT04149444
• Study type: Interventional
• Source: AHS Cancer Control Alberta
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2020
• Completion date: June 9, 2020