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A Study of T-DXd in AI-Assessed HER2-Ultralow Metastatic Breast Cancer

NCT07782086 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-24

No results posted yet for this study

Summary

This is a prospective, multicenter, single-arm study designed to verify the efficacy and safety of trastuzumab deruxtecan (T-DXd) in subjects with hormone receptor-positive (HR+) unresectable and/or metastatic breast cancer who are identified as HER2-ultralow by artificial intelligence (AI)-assisted re-scoring after being manually scored as HER2-null. Eligible subjects will have progressed on at least one and up to two prior lines of endocrine therapy in the metastatic setting. Subjects are permitted to have received no more than one prior chemotherapy in the metastatic setting; however, chemotherapy must not have been the most recent treatment regimen at disease progression. Approximately 30 subjects will be enrolled at about 15 sites in China. The primary endpoint is objective response rate (ORR) by investigator assessment per RECIST 1.1.

Conditions

Interventions

DRUG

Trastuzumab Deruxtecan (T-DXd, ENHERTU®)

5.4 mg/kg IV infusion every 3 weeks (Q3W)

Sponsors & Collaborators

  • Shuangyue Liu

    lead OTHER

Principal Investigators

  • Haomiao Lan · Zigong No.1 Peoples Hospital

  • Ting Wang · The First Affiliated Hospital of Air Force Medicial University

  • Lijia He · The Affiliated Hospital Of Southwest Medical University

  • Hao Wang · Sichuan Cancer Hospital and Research Institute

  • Xuening Ji · Affiliated Zhongshan Hospital of Dalian University

  • Xiaoxiao Liu · The Affiliated Hospital of Xuzhou Medical University

  • Fanfan Li · The Second Hospital of Anhui Medical University

  • Mopei Wang · Peking University Of Third Hospital

  • Fengfeng Cai · Tongji Hospital Tongji University

  • Wei Li · The First Affiliated Hospital with Nanjing Medical University

  • Ouchen Wang · The 1st Affiliated Hospital of WMU

  • Hengyu Li · Changhai Hospital

  • Chunfang Hao · Tianjing Cancer Hospital Airport Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-07
Primary Completion
2029-07-31
Completion
2029-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07782086 on ClinicalTrials.gov