| Title: |
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 |
| Authors: |
Guchelaar,Niels A.D.; Mathijssen,Ron H.J.; de Boer,Maaike; van Bekkum,Marlies L.; Heijns,Joan B.; Vriens,Birgit E.P.J.; van Rosmalen,Mandy M.; Kessels,Lonneke W.; Hamming,Lisanne; Beelen,Karin J.; Nieboer,Peter; van den Berg,Susan M.; Hoop,Esther Oomen de; Bijlsma, Rhodé M.; Bos,Monique E.M.M.; Dutch Breast Cancer Research Group (BOOG); MS Medische Oncologie; Cancer |
| Publication Year: |
2025 |
| Subject Terms: |
Chemotherapy; Metastatic breast cancer; Treatment; Trifluridine-tipiracil; General Medicine |
| Description: |
Background: Effective later-line chemotherapy treatment options are scarce for patients with metastatic breast cancer (MBC). Trifluridine-tipiracil has shown survival benefit in heavily pre-treated patients with metastatic colorectal and in gastric cancer refractory to a fluoropyrimidine. This study aimed to investigate the efficacy of trifluridine-tipiracil in a Western population of previously treated patients with oestrogen receptor (ER+), HER2− MBC to facilitate further optimization of this treatment strategy. Methods: Adult patients at least 18 years old diagnosed with hormone receptor positive, HER2− receptor negative MBC with a performance status of 0 or 1 who have been treated with capecitabine in the metastatic setting and up to two other lines of chemotherapy, including a taxane, were enrolled in this single-arm, multicentre, phase 2 study in the Netherlands. The participants received trifluridine-tipiracil 35 mg/m2 orally twice a day on days 1–5 and days 8–12 during a 28-day cycle until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was the disease control rate (DCR) at 8 weeks, defined as the percentage of patients that had stable disease, partial response or complete response according to RECIST 1.1, in all patients that received at least one dose of trifluridine-tipiracil and met the key eligibility criteria defined a priori. Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and quality of life and were performed in all patients that received at least one dose of trifluridine-tipiracil. The primary endpoint was considered met, justifying further research of this treatment regimen, if the lower boundary of the 80% confidence interval (CI) exceeded 30%. The study was registered within ClinicalTrials.gov (NCT04489173) and is closed for inclusion. Findings: Fifty female patients were enrolled from September 2020 to July 2023, with a median of 3 (IQR, 2–3) previous endocrine therapy lines and 2 (IQR, 2–3) chemotherapy ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
text/plain |
| Language: |
English |
| ISSN: |
2589-5370 |
| Relation: |
https://dspace.library.uu.nl/handle/1874/460476 |
| Availability: |
https://dspace.library.uu.nl/handle/1874/460476 |
| Rights: |
info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.172202EC |
| Database: |
BASE |