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NCT04383275 · ClinicalTrials.gov record · last posted 2026-08-19

Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS)

Name: Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS) — clinical trial record (NCT04383275)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: IRIS

StatusActive, Not Recruiting

PhasePhase 2

SponsorFudan University

Started2020-05-20

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

This is an open label, phase II study evaluating the efficacy and safety of trastuzumab combined with oral chemotherapy or endocrine therapy in patients with HER-2 positive stage I breast cancer.

Protocol amendment history 3 changes detected by DataLookout

2026-08-20

Enrollment closed, study ongoing

2026-08-20

Primary completion pushed: 2025-05-15 → 2031-07-06

2026-08-20

Completion pushed: 2027-05-15 → 2031-07-06

Trial Details

NCT Number	NCT04383275
Lead Sponsor	Fudan University
Conditions	Breast Cancer
Enrollment	367 participants
Start Date	2020-05-20
Primary Completion	2031-07-06 (estimated)
Study Completion	2031-07-06 (estimated)
Updated on ClinicalTrials.gov	2026-08-19