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New drug shows promise for Hard-to-Treat breast cancers in Real-World setting

NCT ID NCT06210776

Disease control Sponsor: Daiichi Sankyo 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study is tracking 800 Chinese patients with advanced HER2-positive or HER2-low breast cancer who are receiving trastuzumab deruxtecan (T-DXd) in real-world clinics. Researchers want to see how long patients stay on treatment and how well it works outside of clinical trials. The goal is to gather practical evidence on effectiveness and safety for these patient groups.

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 study could confirm that trastuzumab deruxtecan is effective and safe for a broader group of Chinese breast cancer patients in everyday clinical practice.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. Side effects like lung inflammation or heart problems are possible with this drug.

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

Jan 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Approximately 800 eligible subjects with HER2+ or HER2-low unresectable or mBC will be enrolled in this study.

Ages

18 years and older

Sex

Anyone

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.

Patients must meet all of the following inclusion criteria to be eligible for the study: 1. ≥18 years of age at time of consent. 2. Pathologically documented breast cancer that is unresectable or metastatic. 3. Cohort A: Patients with confirmed HER2+ (IHC 3+ or IHC2+, ISH+); and patients have received one or more prior anti-HER2-based regimens; and patients should have received no more than 2 lines therapy in the metastatic settings. Cohort B: Patients with confirmed HER2-low expression (IHC 1+ or IHC 2+, ISH-); and patients have received at least a prior systemic therapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy; and patients should have received no more than 2 lines of previous chemotherapy regimen in the metastatic settings. 4. Decision to newly initiate T-DXd or just have started the first dose no longer than 14 days after the index date per approved label in China. 5. Capable of providing informed consent. 6. Patients capable of completing questionnaires are preferred. If the participant is unable to complete the questionnaire (e.g., being blind, illiterate, not fluent in the available language, or ePRO system is not ready), that participant is exempted from completing PRO questionnaires but may still participate in the study. Patients who meet any of the following criteria will be excluded from the study: 1. Pregnancy or breastfeeding. 2. Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded. 3. Patients who have known to have hypersensitivity reactions to the active substance of T-DXd or any excipients. 4. Patients who have been judged by the investigator to be unfit to participate the study.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm cancer HER2 positive breast carcinoma

As listed by the trial registrant

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

Advanced cancer Breast cancer HER2 low breast cancer HER2-positive breast cancer

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    46 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    WITHDRAWN

    Guangzhou, 510060, China

  • Affiliated Cancer Hospital of Xinjiang Medical University

    RECRUITING

    Ürümqi, 830011, China

  • Affiliated Hospital Of Nantong University

    RECRUITING

    Nantong, 226001, China

  • Affiliated Zhongshan Hospital of Dalian University

    RECRUITING

    Dalian, 116001, China

  • Anhui Provincial Cancer Hospital

    WITHDRAWN

    Hefei, 230031, China

  • Beijing GoBroad Hospital

    RECRUITING

    Beijing, 102206, China

  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

    RECRUITING

    Shenzhen, 518116, China

  • Cancer Hospital of Shantou University Medical College

    RECRUITING

    Shantou, 515031, China

  • Changhai Hospital

    RECRUITING

    Shanghai, 200433, China

  • China-Japan Friendship Hospital

    RECRUITING

    Beijing, 100029, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, 200000, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, 350000, China

  • General Hospital of Ningxia Medical University

    WITHDRAWN

    Yinchuan, 750003, China

  • Hainan Cancer Hospital

    RECRUITING

    Haikou, 570311, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, 150081, China

  • Henan Cancer Hospital

    RECRUITING

    Zengzhou, 450003, China

  • Henan Provincial People's Hospital

    RECRUITING

    Zhengzhou, 463599, China

  • Jiamusi Cancer Hospital

    RECRUITING

    Jiamusi, 154007, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, 210029, China

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, 330000, China

  • Liaoning Cancer Hospital & Institute

    RECRUITING

    Shenyang, 110000, China

  • Nanchang Third Hospital

    RECRUITING

    Nanchang, 330000, China

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, 210008, China

  • Ningbo No.2 Hospital

    WITHDRAWN

    Ningbo, 315010, China

  • Peking University First Hospital

    RECRUITING

    Beijing, 100034, China

  • Peking University Shougang Hospital

    RECRUITING

    Beijing, 100144, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, 100191, China

  • Qingdao Central Hospital

    RECRUITING

    Qingdao, 266042, China

  • Shanxi Provincial Cancer Hospital

    RECRUITING

    Taiyuan, 030000, China

  • Sichuan Cancer Hospital

    RECRUITING

    Chengdu, 610041, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, 610072, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, 510120, China

  • Tangshan People's Hospital

    RECRUITING

    Tangshan, 063001, China

  • The Affiliated Hospital of Xuzhou Medical University

    RECRUITING

    Xuzhou, 221004, China

  • The Fifth Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Zhuhai, 519000, China

  • The Fifth Medical Center of the Chinese PLA General Hospital

    WITHDRAWN

    Beijing, 100039, China

  • The First Affiliated Hospital of Henan University of Science & Technology

    ACTIVE_NOT_RECRUITING

    Luoyang, 450052, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, 710061, China

  • The First Affiliated Hospital of Xinxiang Medical University

    RECRUITING

    Xinxiang, 453100, China

  • The First Affiliated Hospital of Zhengzhou University

    WITHDRAWN

    Zhengzhou, 100142, China

  • The First Affilital of Xiamen University

    RECRUITING

    Xiamen, 361003, China

  • The First People's Hospital of Foshan

    RECRUITING

    Foshan, 528000, China

  • The First People's Hospital of Lianyungang

    RECRUITING

    Lianyungang, 222002, China

  • The Peoples of Guangxi Zhuang Autonomous Region

    RECRUITING

    Nanning, 541000, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, 310009, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, 710004, China

  • The University of Hong Kong- Shenzhen Hospital

    RECRUITING

    Shenzhen, 518053, China

  • Tianjin Cancer Hospital Airport Hospital

    RECRUITING

    Tianjin, 300308, China

  • Weifang People's Hospital

    RECRUITING

    Weifang, 261044, China

  • Wenzhou Central Hospital

    RECRUITING

    Wenzhou, 325000, China

  • Xi'an International Medical Center Hospital

    RECRUITING

    Xi'an, 710119, China

  • Yunnan Cancer Hospital

    WITHDRAWN

    Kunming, 650118, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, 310022, China

  • Zhongshan City People's Hospital

    RECRUITING

    Zhongshan, 528403, China

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