A Study of TAS-120 in Patients with Metastatic Breast Cancer
Research type
Research Study
Full title
A Phase 2 Study of TAS-120 in Metastatic Breast Cancers Harboring Fibroblast Growth Factor Receptor (FGFR) Amplifications
IRAS ID
270199
Contact name
Karim Benhadji
Contact email
Sponsor organisation
Taiho Oncology, Inc.
Eudract number
2019-001164-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 15 days
Research summary
FGFR gene mutations, particularly amplifications, play an important role in the development of breast cancer; FGFR1 and FGFR2 gene amplifications are present in approximately 10% and 2%, respectively, of all invasive breast cancers. TAS-120, an inhibitor of FGFR1-4, has shown promising preclinical activity in the treatment of
breast cancers and other cancer types; in a Phase 1 clinical study, TAS-120 monotherapy was associated with 2 durable partial responses (PRs) in patients with treatment-refractory breast cancer.Accordingly, this Phase 2 study will include patients with breast cancer harboring FGFR gene amplifications. Recent evidence suggests that the addition of an FGFR inhibitor may overcome resistance to hormonal therapy in breast cancer.
This is a Phase 2, open-label, non-randomized, multicenter study designed to evaluate the efficacy and safety of TAS-120 and TAS-120 + fulvestrant in adult patients with locally advanced/metastatic breast cancer harbouring FGFR gene amplifications. 168 patients globally will be enrolled to 1 of 4 treatment cohorts based on diagnosis and FGFR gene amplification status, and will receive either single agent TAS-120 in Cohorts 1-3 or TAS-120 plus fulvestrant in Cohort 4.
Treatment will continue until disease progression, unacceptable toxicity, or any other of the criteria for treatment discontinuation is met. For patients who discontinue treatment for reasons other than disease progression, tumor assessments should be continued until radiologic disease progression is documented or until initiation of subsequent new anticancer therapy (whichever occurs first). Patients will be followed for survival every 12 weeks until survival events (deaths) have been reported for 75% of enrolled patients or the study is terminated early by the Sponsor.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/1608
Date of REC Opinion
22 Nov 2019
REC opinion
Further Information Favourable Opinion