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Breast cancer study seeks to match drug to tumor patterns

NCT ID NCT06551220

Knowledge-focused Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study tracks 800 people with metastatic breast cancer to see if differences in HER2 levels across tumors affect how well trastuzumab deruxtecan works. Researchers will compare progression-free and overall survival based on HER2 patterns. The goal is to better understand who benefits most from this targeted therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trastuzumab deruxtecan (T-DXd)
What this could lead to
If successful, this could help doctors predict which patients with metastatic breast cancer will benefit most from trastuzumab deruxtecan based on HER2 patterns.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test a new therapy, and results may not change practice immediately.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study is a multicenter, retrospective study led by the Sun Yat-sen University Cancer Center. A total of 16 centers are planned to participate in the study, and it aims to include patients with advanced or locally unresectable breast cancer who have received treatment with T-DXd.

Ages

18 to 80 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with advanced or locally unresectable breast cancer; * Treated with T-DXd (DS-8201, trastuzumab deruxtecan) regardless of line of therapy, HR, and HER2 expression level; * HER2 immunohistochemistry staining information of the primary lesion or metastatic/recurrent lesion; * Measurable lesions with treatment response results that can be evaluated through imaging examinations; * Able to follow up with the latest progression-free survival or overall survival. Exclusion Criteria: * Patients with missing basic clinical information or HER2 immunohistochemistry staining information; * Patients with missing pathological results for both primary and metastatic/recurrent lesions; * Patients with no measurable lesions and unable to evaluate T-DXd treatment response; * Discontinue T-DXd therapy for unacceptable adverse events or other reasons; * Patients lost to follow-up after T-DXd treatment.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Cancer Hospital of Inner Mongolia Medical University

    RECRUITING

    Hohhot, Inner Mongolia, China

  • Cancer Hospital of Shantou University Medical College

    RECRUITING

    Shantou, Guangdong, 515041, China

  • Changde Hospital, Xiangya School of Medicine, Central South University

    RECRUITING

    Changde, Hunan, China

  • Dana-Farber Cancer Institute, Harvard Medical School

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Fujian Cancer Hospital, Fujian Medical University

    RECRUITING

    Fuzhou, Fujian, China

  • Guangdong Provincial Hospital of Chinese Medicine

    RECRUITING

    Guangzhou, Guangdong, China

  • Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

    RECRUITING

    Changsha, Hunan, 410013, China

  • National Cancer Center Shenzhen Hospital

    RECRUITING

    Shenzhen, Guangdong, China

  • Shenzhen People's Hospital

    RECRUITING

    Shenzhen, Guangdong, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • The 10th Affiliated Hospital of Southern Medical University

    RECRUITING

    Dongguan, Guangdong, China

  • The Affiliated Cancer Hospital, Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • The Affiliated Panyu Central Hospital, Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 511400, China

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Zhuhai, Guangdong, 519000, China

  • The First Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • The First Affiliated Hospital, Hengyang Medical School, University of South China

    RECRUITING

    Hengyang, Hunan, China

  • The First People's Hospital of Foshan

    RECRUITING

    Foshan, Guangdong, China

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, China

  • The Sixth Affiliated Hospital, School of Medicine, South China University of Technology.

    RECRUITING

    Foshan, Guangdong, China

  • Xinhua Hospital Afliated to Shanghai Jiaotong University

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • Yuebei People's Hospital of Shantou University

    RECRUITING

    Shaoguan, Guangdong, China

  • Zhongshan City People's Hospital

    RECRUITING

    Zhongshan, Guangdong, China

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