NCT04149444

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Trifluridine/Tipiracil	Oral medication

Timeline

• Start date: 2020-02-01
• Primary completion: 2020-06-09
• Completion: 2020-06-09
• First posted: 2019-11-04
• Last updated: 2020-06-11

Locations

1 site across 1 country: Canada