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NCT04024436 · ClinicalTrials.gov registry record · Phase 2

A Study of TAS-120 in Patients With Metastatic Breast Cancer

A Phase 2 study, sponsored by Taiho Oncology.

Terminated
Registry status
Phase 2
Development phase
64
Enrollment target

NCT04024436: Clinical Trial Phase 2 study, sponsored by Taiho Oncology.

NCT04024436 is a Phase 2 study that was terminated before completion, run by Taiho Oncology. The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04024436, a Phase 2 study, was terminated before completion, sponsored by Taiho Oncology.

TERMINATED
Registry status
Phase 2
Development phase
64 participants
Enrollment target

Study Summary

The purpose of the trial is to evaluate a patient's response to a Fibroblast Growth Factor Receptor (FGFR) inhibitor, futibatinib (TAS-120), used either alone or in combination with the hormonal therapy, fulvestrant. This study will be conducted in patients with metastatic breast cancer who have specific Fibroblast Growth Factor Receptor gene abnormalities and who have previously received conventional therapies to treat their breast cancer, or who are not able to tolerate certain cancer therapies. This study will also evaluate the safety of taking futibatinib, or futibatinib and fulvestrant, by learning about the potential side effects.

Primary Outcome

ORR was defined as the percentage of participants with a confirmed response of either complete response (CR) or partial response (PR), based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall resp

Interventions

  • DRUG Futibatinib
  • DRUG Futibatinib plus Fulvestrant

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2020-01-28
Est. Completion 2023-09-06
Phase Phase 2
Taiho Oncology

52 total trials

Why NCT04024436 stopped before completion

NCT04024436 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).

The record links to 0 conditions, and to 2 interventions - of which Futibatinib is the first listed.

NCT04024436 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04024436 about?

NCT04024436 is a clinical study titled "A Study of TAS-120 in Patients With Metastatic Breast Cancer". The purpose of the trial is to evaluate a patient's response to a Fibroblast Growth Factor Receptor (FGFR) inhibitor, futibatinib (TAS-120), used either alone or in combination with the hormonal therapy, fulvestrant. This study will be conducted in patients with metastatic breast cancer who have spe...

What is the current status of trial NCT04024436?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2020-01-28. Estimated completion is 2023-09-06.

What interventions are being tested in trial NCT04024436?

The interventions under investigation include: Futibatinib (DRUG), Futibatinib plus Fulvestrant (DRUG).

Who is sponsoring clinical trial NCT04024436?

This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04024436's enrollment target sits among peer trials

64 996th of 2000 higher than 992 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04024436, the US trial registry maintained by the National Library of Medicine. NCT04024436 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.