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

NCT04280536 | Active Not Recruiting Phase 1

• 1 other identifier: BR01/02/19
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

FTD/TPI; TAS-102; Trifluridine

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Primary endpoint is proportion of patients who are PFS at 4 months in Cohort A

  4 months

Secondary Outcomes (3)

• Overall Response

  5 years

• Progression Free Survival (PFS)

  6 months

• Safety and Efficacy

  5 years

Study Arms (2)

Cohort A

EXPERIMENTAL

Patients with prior exposure to fluoropyrimidines

Drug: Cohort A

Cohort B

EXPERIMENTAL

Patients without prior exposure to fluoropyrimidines

Drug: Cohort B

Interventions

Cohort A DRUG

Oral FTD/TPI at RP2D will be administered until disease progression, intolerable toxicity or patient withdrawal.

Also known as: trifluridine/tipiracil, TAS-102 [Lonsurf]

Cohort A

Cohort B DRUG

Oral FTD/TPI at RP2D will be administered until disease progression, intolerable toxicity or patient withdrawal.

Also known as: trifluridine/tipiracil, TAS-102 [Lonsurf]

Cohort B

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 21 years.
• Histological or cytological diagnosis of breast carcinoma.
• ECOG 0-2.
• HER2 negative tumor (IHC 0 -1+ or IHC 2+ and confirmed on HER2 FISH to be negative based on histological report).
• Patients with HER2 positive tumor may be enrolled if they have failed at least two lines of anti-HER2 based therapies in the metastatic setting, or are intolerant to trastuzumab
• Any hormone receptor status.
• Any number of lines of prior palliative endocrine therapy for patients with hormone receptor positive cancer.
• Has measureable or evaluable disease based on RECIST 1.1 criteria
• Estimated life expectancy of at least 12 weeks.
• Has documented progressive disease from last line of therapy.
• Has recovered from acute toxicities from prior anti-cancer therapies
• Adequate organ function including the following:
• oBone marrow: (I) Absolute neutrophil (segmented and bands) count (ANC) ≥1.5 x 109/L (ii) Platelets ≥100 x 109/L (ii) Hemoglobin ≥8 x 109/L oHepatic: (I)Bilirubin ≤ 1.5 x upper limit of normal (ULN), (ii)ALT or AST ≤ 2.5x ULN, (or ≤ 5 X with liver metastases) oRenal: (I) Creatinine ≤1.5x ULN
• Signed informed consent from patient or legal representative.
• Able to comply with study-related procedures.

You may not qualify if:

• Treatment within the last 30 days with any investigational drug.
• Concurrent administration of any other tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
• Major surgery within 28 days of study drug administration.
• Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
• Pregnancy.
• Breast feeding.
• Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
• Active bleeding disorder or bleeding site.
• Non-healing wound.
• Poorly controlled diabetes mellitus.
• Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
• Symptomatic brain metastasis.
• History of significant neurological or mental disorder, including seizures or dementia.
• Unable to comply with study procedures

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Related Publications (2)

• Caswell-Jin JL, Plevritis SK, Tian L, Cadham CJ, Xu C, Stout NK, Sledge GW, Mandelblatt JS, Kurian AW. Change in Survival in Metastatic Breast Cancer with Treatment Advances: Meta-Analysis and Systematic Review. JNCI Cancer Spectr. 2018 Nov;2(4):pky062. doi: 10.1093/jncics/pky062. Epub 2018 Dec 24.

  PMID: 30627694 BACKGROUND

• Crown J, Dieras V, Kaufmann M, von Minckwitz G, Kaye S, Leonard R, Marty M, Misset JL, Osterwalder B, Piccart M. Chemotherapy for metastatic breast cancer-report of a European expert panel. Lancet Oncol. 2002 Dec;3(12):719-27. doi: 10.1016/s1470-2045(02)00927-0.

  PMID: 12473512 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Soo Chin Lee

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 parallel cohorts of patients will be enrolled : Cohort A : patients with prior exposure to fluoropyrimidines Cohort B : patients without prior exposure to fluoropyrimidines

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 21, 2020
• Study Start: August 14, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)