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Breast NeoplasmPhase 2TIBETNCT04489173

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

A Phase 2 study testing trifluridine/tipiracil in people with Breast Neoplasm and Chemotherapy Effect, run by Borstkanker Onderzoek Groep at 10 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multicenter phase 2 study evaluating the efficacy and safety of trifluridine/tipiracil in women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasm, Chemotherapy Effect
What is being tested?
trifluridine/tipiracil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
10 sitesNetherlands
Study dates
25 Sep 2020to 19 May 2026
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult women(≥ 18 years of age) with proven diagnosis of metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy
  • Documented ER positive (10%) and/or PR positive (10%) and HER2 negative metastatic breast cancer
  • Progressive disease based on imaging
  • Women previously treated with capecitabine (in metastatic setting), and a maximum of two other lines of chemotherapy including a taxane either in the (neo)adjuvant or metastatic setting.
  • Evaluable disease as defined per RECIST v.1.1 (see Appendix B). Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated site after completion of therapy is clearly documented.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
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  • Life expectancy of ≥ 12 weeks
  • Willing and able to comply with scheduled visits and study procedures
  • Adequate organ, bone marrow and coagulation function as shown by:
  • Absolute neutrophil count (ANC) ≥ 1.5 ×109/L
  • Platelets ≥ 75 ×109/L
  • Hemoglobin (Hgb) ≥ 5.6 mmol/L
  • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN (or ≤ 5 if hepatic metastases are present)
  • Total serum bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients known to have Gilbert Syndrome)
  • Creatinine clearance ≥60 ml/min
  • Written informed consent obtained before any screening procedure and according to local guidelines.
  • Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 Grade ≤1, except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion.

Who cannot join

  • HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive) and ER-negative patients are not eligible
  • No more than two lines of chemotherapy for advanced disease
  • Resolution of side-effects from previous chemotherapy > grade 1 (except for alopecia)
  • Radiotherapy within four weeks prior to enrollment is not allowed except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. Patients must have recovered from radiotherapy toxicities prior to enrollment.
  • 30% or more marrow-bearing bone being irradiated. Other primary tumors within the last 5 years before study entry are not allowed, except for adequately controlled basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
  • Previous or current CNS metastases, carcinomatous meningitis, are not allowed. A CT or MRI of the brain must be performed within 4 weeks prior to registration if the presence of metastases at this site is suspected.
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  • Evidence of clinically significant cardiovascular or pulmonary disease or any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or that may affect patient compliance with study routines, or places the patient at high risk from treatment related complications. (e.g lactose intolerance)
  • Previously received trifluridine/tipiracil
  • Since trifluridine/tipiracil contains lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine
  • Diagnosis of any other malignancy prior to registration, except those that are not believed to influence the patient's prognosis and do not require any further treatment.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Netherlands10 sites

  • 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

Other trials in Netherlands

About this study

Official title: A Phase 2 Study of Trifluridine/Tipiracil in Patients With ER-positive, HER2-negative Advanced Breast Cancer That Previously Received Chemotherapy

This is a multicenter phase 2 study evaluating the efficacy and safety of trifluridine/tipiracil in women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.

Read the detailed description

Multicenter phase 2 study evaluating the efficacy and safety of trifluridine/tipiracil in women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy. This study will be conducted under the sponsorship of BOOG, Amsterdam, NL.

Objectives:

To evaluate the efficacy of trifluridine/tipiracil by determination of the percentage of patients being progression free at 8 weeks on trifluridine/tipiracil prescribed for ER-positive, HER2-negative advanced breast cancer patients previously treated with a taxane and capecitabine.

Endpoints:

Progression-free survival at 8 weeks.

Progression-free survival.

Response rate CR/PR at 16 weeks.

Adverse events.

Translational research on biological factors that may be of influence on the outcome of treatment.

QoL.

Main eligibility criteria:

Metastatic Her2 negative, ER-positive breast cancer patients that progressed on, or after treatment with Capecitabine. Previous treatment with Taxanes is obligatory. Adequate hematology, liver and renal function tests.

Being tested
trifluridine/tipiracil
Keywords
TAS102
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • trifluridine/tipiracilDrug

    Also called Lonsurf, TAS102

    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.

Study groups in NCT04489173
Study groupRoleWhat they receive
TreatmentExperimentalTreatment with TAS102
Receives: Drug: trifluridine/tipiracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Response rate CR/PR

    Measured: 8 weeks

Secondary outcomes (2)

  1. Adverse events

    CTCAE version 4.0

    Measured: every 4 weeks

  2. QoL

    Quality of Life questionnaire EORTC QLQ-C30

    Measured: 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2020
  2. Study start25 Sep 2020
  3. Primary completion8 Jan 2024
  4. Study completion19 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Multicenter, single arm, phase 2 study evaluating the efficacy and safety of trifluridine/tipiracil in women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy. 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.
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04489173
Sponsor's protocol ID
BOOG 2019-01
Acronym
TIBET
Status last verified
May 2026
First submitted
22 Jul 2020
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Guchelaar NAD, Mathijssen RHJ, de Boer M, van Bekkum ML, Heijns JB, Vriens BEPJ, van Rosmalen MM, Kessels LW, Hamming L, Beelen KJ, Nieboer P, van den Berg SM, Hoop EO, Bijlsma RM, Bos MEMM; Dutch Breast Cancer Research Group (BOOG). Trifluridine-tipiracil in previously treated patients with oestrogen receptor-positive, HER2-negative metastatic breast cancer (BOOG 2019-01 TIBET trial): a single-arm, multicentre, phase 2 trial. EClinicalMedicine. 2025 Jan 27;80:103065. doi: 10.1016/j.eclinm.2024.103065. eCollection 2025 Feb.

    PubMed 40017682

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