NCT04280536

Phase II Study of FTD/TPI (Lonsurf) in Metastatic Breast Cancers With or Without Prior Exposure to Fluoropyrimidines (LONBRECA)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-label, lead in phase Ib dose confirmation, followed by phase II study with 2 parallel study cohorts.

Detailed description

Phase Ib Patients will be treated with twice-daily dosing of FTD/TPI in a 3+3 dose escalation design Phase II Oral FTD/TPI at RP2D will be administered until disease progression, intolerable toxicity or patient withdrawal. 2 parallel cohorts of patients will be enrolled : Cohort A : patients with prior exposure to fluoropyrimidines Cohort B : patients without prior exposure to fluoropyrimidines

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Cohort A	Oral FTD/TPI at RP2D will be administered until disease progression, intolerable toxicity or patient withdrawal.
DRUG	Cohort B	Oral FTD/TPI at RP2D will be administered until disease progression, intolerable toxicity or patient withdrawal.

Timeline

• Start date: 2019-08-14
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2020-02-21
• Last updated: 2025-09-23

Locations

1 site across 1 country: Singapore