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Breast CancerVeri-HER2ULNCT07782086

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

A study testing Trastuzumab Deruxtecan (T-DXd, ENHERTU®) in people with Breast Cancer, run by Shuangyue Liu at 14 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Trastuzumab Deruxtecan (T-DXd, ENHERTU®)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
14 sitesChina
Study dates
7 Sep 2026to Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For inclusion in the study subjects should fulfil the following criteria based on local regulations:
  • Provision of ICF prior to any study-specific qualification procedures.
  • Adults ≥ 18 years of age at the time the ICF is signed.
  • Must have an adequate tumor tissue sample available for assessment of HER2 status obtained most recently at the time of metastatic disease or later. If a suitable archival sample is not available, a fresh biopsy sample may be used to determine eligibility.
  • Pathologically documented BC that:
  • Is unresectable and/or metastatic.
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  • Is documented as HR+ (either estrogen receptor [ER] and/or progesterone receptor [PR] positive [ER or PR ≥1%]) per ASCO CAP guidelines32 in the metastatic setting. If a patient has had multiple ER/PR results after metastatic disease, the most recent test result will be used to confirm eligibility.
  • Has a history of HER2 IHC 0 (with/without membrane staining).
  • Was never previously reported as HER2+ (IHC 3+ or ISH+) as per ASCO CAP guidelines.
  • Is scored as HER2-null (IHC 0; no membrane staining) by a local laboratory using the PATHWAY/VENTANA® HER2 (4B5) assay, and subsequently re-scored as HER2-ultralow (IHC 0; with membrane staining) under AI assistance by the central laboratory based on the stained slides sent by local laboratory.
  • Must have progressed on at least one and up to two prior lines of ET ± targeted therapy in the metastatic setting.
  • Have received no more than one chemotherapy in the metastatic setting but chemotherapy must not be the most recent treatment for patients at disease progression.
  • Presence of at least one measurable lesion based on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the Investigator, per RECIST version 1.1.
  • Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
  • Has a minimum life expectancy of 12 weeks at Screening.
  • Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days before enrollment.
  • Adequate organ and bone marrow function within 14 days before enrolment.. All parameters must be the most recent results available.
  • Note: Transfusion (red blood cell or platelet) or granulocyte colony-stimulating factor (G-CSF) administration is not allowed within 14 days prior to the day on which bone marrow function is assessed, or at any time after this day and prior to Cycle 1 Day 1 (C1D1).
  • Adequate treatment washout period before enrollment,
  • Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner. For women of childbearing potential, a negative result for serum pregnancy test (test must have a sensitivity of at least 25 mIU/mL) must be available at the Screening visit and urine beta-human chorionic gonadotropin (β-HCG) pregnancy test prior to each administration of study treatment.Women of childbearing potential are defined as those who are not surgically sterile (i.e. underwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
  • Female subjects of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 4 from the time of Screening and must agree to continue using such precautions for 7 months after the last dose of study treatment. Not all methods of contraception are highly effective. It is strongly recommended that non-sterilized male partners of female subjects of childbearing potential use a male condom plus spermicide while on study and for 7 months after the last dose of study treatment (note: male condoms are not reliable as a sole contraception method). Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is in line with the subject's usual lifestyle (consideration must be made to the duration of the clinical study); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.
  • Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide from Screening to 4 months after the final dose of study treatment. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is in line with the subject's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable. It is strongly recommended for the female partners of a male subject to also use at least one highly effective method of contraception throughout this period, as described in Table 4. In addition, male subjects should refrain from fathering a child throughout the study Treatment Period and for 4 months after the last dose of study treatment. Male subjects should refrain from freezing or donating sperm from the time of first exposure until 4 months after the final dose of the study treatment. Preservation of sperm should be considered prior to enrollment in this study.
  • Female subjects must not donate, or retrieve for their own use, ova from the time of enrollment and throughout the study Treatment Period, and for at least 7 months after the final study treatment administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrollment in this study.

Who cannot join

  • Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
  • Subjects with contraindications to T-DXd per the local prescribing information and T-DXd IB cannot be enrolled to the study.
  • Previous treatment with anti-HER2 therapy.
  • Prior treatment with an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor.
  • Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
  • Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
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  • Subjects with a medical history of myocardial infarction (MI) within 6 months before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV). Subjects with troponin levels above upper limit of normal (ULN) at Screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrollment to rule out MI.
  • Corrected QT interval by Fredericia's method (QTcF) prolongation to > 470 ms (females) or > 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG).
  • History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
  • Lung criteria:
  • Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g. pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disorder [COPD], restrictive lung disease, pleural effusion, etc.).
  • Any autoimmune, connective tissue or inflammatory disorders (including Rheumatoid arthritis, Sjogren's and sarcoidosis) where there is documented, or a suspicion of pulmonary involvement at the time of Screening.
  • Prior pneumonectomy (complete).
  • Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals.
  • Active primary immunodeficiency, known uncontrolled active human immunodeficiency virus (HIV) infection, or active hepatitis B (hepatitis B virus surface antigen [HBsAg] or hepatitis B virus core antibody [HBcAb] positive, at Screening) or C virus infection. Subjects should be tested for HIV prior to enrollment if required by local regulations or institutional review board (IRB)/ethics committee (EC). Subjects positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). Subjects with past or resolved hepatitis B virus (HBV) infection are eligible only if they meet all of the following criteria:
  • HBsAg (-) (for > 6 months off anti-viral treatment).
  • Anti-hepatitis B core antibody (HBc) (+) (IgG or total Ig).
  • HBV DNA undetectable.
  • Absence of cirrhosis or fibrosis on prior imaging or biopsy.
  • Absence of HCV co-infection or history of HCV co-infection.
  • Access to a local hepatitis B expert during and after the study. Such subjects should be closely monitored for HBV reactivation. Further instructions for monitoring and management of subjects at risk of HBV reactivation are provided in Appendix C.
  • Receipt of live, attenuated vaccine (messenger RNA [mRNA] and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of study treatment.
  • Note: Subjects, if enrolled, should not receive live vaccine during the study and up to 90 days after the last dose of study treatment.
  • Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to >Grade 2 for at least 3 months prior to enrollment and managed with standard-of-care treatment) that the Investigator deems related to previous anticancer therapy, such as:
  • Chemotherapy-induced neuropathy.
  • Fatigue.
  • Residual toxicities from prior immuno-oncology (IO) treatment: Grade 2 endocrinopathies which may include:
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  • Hypothyroidism/hyperthyroidism.
  • Type 1 diabetes.
  • Hyperglycemia.
  • Adrenal insufficiency.
  • Adrenalitis.
  • Skin hypopigmentation (vitiligo).
  • Known allergy or hypersensitivity to study treatment or any of the study drug excipients.
  • History of severe hypersensitivity reactions to other monoclonal antibodies.
  • Pregnant or breastfeeding female subjects, or subjects who are planning to become pregnant.
  • Multiple primary malignancies within 3 years, with the exception of:
  • Adequately resected non-melanoma skin cancer.
  • Curatively treated in-situ disease.
  • Other solid tumors curatively treated.
  • Contralateral BC.
  • Any other clinically significant medical conditions, that may, in the opinion of the Investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.
  • Social, familial, or geographical factors that would interfere with study participation or follow-up.

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

ping zhang contact

028-85422953

zheng.zd@wchscu.cn

14 sites in 1 country

China14 sites

  • Peking University Of Third Hospital

    Beijing, Beijing Municipality

    Mopei Wang

  • Sichuan Cancer Hospital

    Chengdu, Sichuan

    Hao Wang, unique909@126.com

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Ting Luo, 028-85422953, luoting@wchscu.cn

  • Affiliated Zhongshan Hospital Of Dalian University

    Dalian, Liaoning

    Xuening Ji, 1544136878@qq.com

  • The Second Affiliated Hospital Of Anhui Medical University

    Hefei, Anhui

    Fanfan Li, fflahykdx@163.com

  • The Affiliated Hospital Of Southwest Medical University

    Luzhou, Sichuan

    Lijia He, 908380148@qq.com

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

    Wei Li, liwei1218@njmu.edu.cn

  • Changhai Hospital

    Shanghai, Shanghai Municipality

    Hengyu Li, drlhy@foxmail.com

  • Tongji Hospital Tongji University

    Shanghai, Shanghai Municipality

    Fengfeng Cai, 15221184079@163.com

  • Tianjing Cancer Hospital Airport Hospital

    Tianjin, Tianjin Municipality

    Chunfang Hao, haochf@163.com

  • The 1st Affiliated Hospital of WMU

    Wenzhou, Zhejiang

    Ouchen Wang, woc@wmu.edu.cn

  • Xijing Hospital, Air Force Medical University

    Xi’an, Shanxi

    Ting Wang, ting_w100@126.com

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Xiaoxiao Liu, drliuxx@126.com

  • Zigong First People's Hospital

    Zigong, Sichuan

    Haomiao Lan, 5788127@qq.com

Other trials in China

About this study

Official title: A Prospective, Multicenter, Single-Arm Study Verifying the Benefit of Trastuzumab Deruxtecan (T-DXd) in AI Re-Scored HER2-Ultralow (HER2UL) Unresectable or Metastatic Breast Cancer Manually Scored as HER2-Null

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.

Read the detailed description

This is a prospective, multicenter, single-arm, open-label study. The study will consist of four periods: Tissue Screening, Screening, Treatment, and Follow-up (including long-term follow-up). Subjects will receive T-DXd 5.4 mg/kg via intravenous infusion on Day 1 of each 21-day cycle. Radiographic tumor assessments will be performed every 6 weeks for the first 24 weeks, and then every 12 weeks thereafter until investigator-assessed disease progression. The primary objective is to evaluate the efficacy as assessed by ORR. Secondary objectives include PFS, DCR, and DoR. Safety will be assessed by TEAEs, SAEs, AESIs, and laboratory findings. One interim analysis is planned at approximately 6 months after the last subject enrolled. The study is expected to enroll 30 subjects at approximately 15 sites in China. The End of Study is defined as the timepoint at which 20 PFS events have been observed, estimated to occur approximately 15 months after the last subject is enrolled.

Conditions
Breast Cancer
Being tested
Trastuzumab Deruxtecan (T-DXd, ENHERTU®)
Keywords
Breast Cancer, HER2-ultralow, Trastuzumab Deruxtecan, T-DXd, AI-assisted Pathology, Metastatic Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab Deruxtecan (T-DXd, ENHERTU®)Drug

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

Study groups in NCT07782086
Study groupRoleWhat they receive
Trastuzumab Deruxtecan (T-DXd) Treatment ArmExperimentalSingle-arm treatment group: All participants will receive trastuzumab deruxtecan (T-DXd) 5.4 mg/kg intravenously every 3 weeks until disease progression, unacceptable toxicity, or study withdrawal.
Receives: Drug: Trastuzumab Deruxtecan (T-DXd, ENHERTU®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by Investigator.

    Measured: From first dose to progression/death, assessed every 6 weeks for 24 weeks, then every 12 weeks, up to approximate 36 months following subject enrolment.

Secondary outcomes (3)

  1. PFS

    PFS is defined as the time from first dose of study treatment until progression per RECIST 1.1 as assessed by Investigator, or death due to any cause in the absence of progression regardless of whether the subject withdraws from study treatment or received another anticancer therapy prior to progression.

    Measured: From first dose to progression/death, assessed every 6 weeks for 24 weeks, then every 12 weeks, up to approximate 36 months following subject enrolment.

  2. DCR

    DCR is defined as the percentage of subjects who have a BOR of CR/PR/SD.

    Measured: From first dose to progression/death, assessed every 6 weeks for 24 weeks, then every 12 weeks, up to approximate 36 months following subject enrolment .

  3. DoR

    DoR is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression as assessed by the Investigator per RECIST 1.1 or death in the absence of disease progression.

    Measured: From confirmed response to progression/death, assessed every 6 weeks for 24 weeks, then every 12 weeks, up to approximate 36 months following subject enrolment .

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2026
  2. Study start7 Sep 2026 (estimated)
  3. Primary completionJul 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single-arm, open-label, Post marketl study. All eligible subjects will receive trastuzumab deruxtecan (T-DXd) at 5.4 mg/kg via intravenous infusion every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or study withdrawal. No control group is included; all studys are assigned to the same treatment arm to evaluate the efficacy and safety of T-DXd in subjects7/6/2026 with manually scored HER2-null, AI re-scored HER2-ultralow (HER2UL) unresectable or metastatic breast cancer.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07782086
Sponsor's protocol ID
D9673L00026
Acronym
Veri-HER2UL
Status last verified
Aug 2026
First submitted
6 Jul 2026
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The sponsor doesn't intend to share de-identified individual subjects data with external investigator due to confidentiality restrictions and limited resources for data

Questions about this trial

What is this clinical trial studying?

A study testing Trastuzumab Deruxtecan (T-DXd, ENHERTU®) in people with Breast Cancer, run by Shuangyue Liu at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ping zhang (028-85422953, zheng.zd@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: From first dose to progression/death, assessed every 6 weeks for 24 weeks, then every 12 weeks, up to approximate 36 months following subject enrolment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07782086.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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