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NCT03248492 · ClinicalTrials.gov registry record · Phase 2

A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)

A Phase 2 study, sponsored by Daiichi Sankyo.

Terminated
Registry status
Phase 2
Development phase
253
Enrollment target

NCT03248492: Clinical Trial Phase 2 study, sponsored by Daiichi Sankyo.

NCT03248492 is a Phase 2 study that was terminated before completion, run by Daiichi Sankyo. The registered enrollment target is 253 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03248492, a Phase 2 study, was terminated before completion, sponsored by Daiichi Sankyo.

TERMINATED
Registry status
Phase 2
Development phase
253 participants
Enrollment target

Study Summary

Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients.

Primary Outcome

The number of participants with objective response was assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment, by independent central imaging facility review based on RECIST version 1.1.

Interventions

  • DRUG DS-8201a

Trial Details

FieldValue
Enrollment Target 253 participants
Start Date 2017-08-25
Est. Completion 2024-05-06
Phase Phase 2
Daiichi Sankyo

236 total trials

Why NCT03248492 stopped before completion

NCT03248492 is an interventional study that assigns participants to a tested intervention. The registered 253 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% higher).

The record links to 0 conditions, and to 1 intervention - of which DS-8201a is the first listed.

NCT03248492 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03248492 about?

NCT03248492 is a clinical study titled "A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)". Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. Thi...

What is the current status of trial NCT03248492?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 253 participants. The study started on 2017-08-25. Estimated completion is 2024-05-06.

What interventions are being tested in trial NCT03248492?

The interventions under investigation include: DS-8201a (DRUG).

Who is sponsoring clinical trial NCT03248492?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03248492's enrollment target sits among peer trials

253 220th of 2000 higher than 1,781 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 NCT03248492, the US trial registry maintained by the National Library of Medicine. NCT03248492 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.