HER2 OverexpressionNCT07035353
A Real-world Clinical Study of T-DXd for the Treatment of Chinese Patients With HER2 Overexpressing and HER2 Underexpressing Advanced Breast Cancer
An observational study of HER2 Overexpression and Advanced Stage Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
The study is an open, prospective study to collect data on the efficacy and safety of T-DXd (DS8201) in Chinese patients with HER2 overexpressing and HER2 underexpressing advanced breast cancer in actual clinical practice in China. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2 Overexpression, Advanced Stage Breast Cancer, Low Expression of HER2
- What is being tested?
- T-DXd (DS8201) 5.4 mg/kg, IVD, 1 cycle every 21 days.
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 1 May 2035
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving T-DXd (DS8201) for HER2 overexpression and HER2 underexpression advanced breast cancer in actual clinical practice in China Chinese patients
Who may be able to join
- Must be competent and able to sign and date an Institutional Review Board (IRB) or Ethics Committee (EC)-approved ICF prior to any study-specific procedure or trial.
- Female patients aged ≥18 years with advanced breast cancer who are adults.
- Pathologically confirmed breast cancer that meets the following criteria:
- unresectable or metastatic, with evidence of recurrent or metastatic disease.
- HER2 overexpression, or HER2 hyperexpression as determined by the central laboratory in accordance with the American Society of Clinical Oncology-Society of American Pathologists guidelines.
- Patients must have measurable lesions according to RECIST 1.1 criteria.
- Unmenopausal, menopausal, and perimenopausal female patients were allowed to be enrolled.
- Prior antitumor therapy against recurrent metastatic disease is allowed.
Who cannot join
- Early stage breast cancer
- Patients who do not meet the criteria for HER2 overexpression and HER2 underexpression.
- Female patients during pregnancy or lactation.
- Patients deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Study Evaluating the Efficacy and Safety of Real-world T-DXd in Treating Chinese Patients With HER2 Overexpression and HER2 Underexpression Advanced Breast Cancer
The study is an open, prospective study to collect data on the efficacy and safety of T-DXd (DS8201) in Chinese patients with HER2 overexpressing and HER2 underexpressing advanced breast cancer in actual clinical practice in China.
Cohort A:
Read more
HER2 overexpressing patients with advanced breast cancer
Cohort B:
HER2 underexpressing patients with advanced breast cancer A total of 400 subjects will be enrolled in the program, with 200 enrolled in Cohort A and 200 enrolled in Cohort B. The study will be conducted by a physician in accordance with current clinical practice. The treatment plan will be recommended to the subjects by the treating physician based on the current clinical practice guidelines in conjunction with the clinical practice, and the patient's decision to be treated with T-DXd (DS8201) should precede enrollment in this study. Because of the non-interventional nature of this study, this study does not alter or interfere with clinician treatment decisions, and the actual medical practice of patients.
Inclusion in the study after the first treatment with the drug is based on inclusion/exclusion criteria. Subject enrollment in this study should be within 2 months of the subject's first dose of medication and prior to the first efficacy assessment. Demographic data, past medical and treatment history, ECOG score, vital signs + physical examination, laboratory tests, objective tumor evaluation, coadministration/concomitant therapy, adverse events, time to progression/death, and subsequent antitumor therapy were collected at baseline, during treatment, and at subsequent follow-up. Imaging evaluation was performed according to RECIST 1.1 criteria. Adverse events evaluation criteria were based on NCI-CTCAE version 5.0.
- Being tested
- T-DXd (DS8201) 5.4 mg/kg, IVD, 1 cycle every 21 days.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-DXd (DS8201) 5.4 mg/kg, IVD, 1 cycle every 21 days.Drug
The treatment plan will be recommended to the subject by the treating physician in accordance with current clinical practice guidelines and clinical practice, and the patient's decision to receive T-DXd (DS8201) should precede enrollment in this study. The strategy for administering a particular treatment to a subject is not determined a priori by the trial protocol, but should be in accordance with current clinical practice. Because of the non-interventional nature of this study, this study does not alter or interfere with the patient's actual current medical practice.
| Study group | Role | What they receive |
|---|---|---|
| HER2 overexpression in advanced breast cancer patients | Not described Receives: Drug: T-DXd (DS8201) 5.4 mg/kg, IVD, 1 cycle every 21 days. | |
| Patients with advanced breast cancer with low HER2 expression | Not described Receives: Drug: T-DXd (DS8201) 5.4 mg/kg, IVD, 1 cycle every 21 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess progression-free survival (PFS) of Chinese patients with advanced breast cancer with HER2 overexpression and HER2 underexpression treated with real-world T-DXd (DS8201).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 OverexpressionStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035353
- Sponsor's protocol ID
- TDXD2025
- Status last verified
- Apr 2025
- First submitted
- 12 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Efficacy and Safety of Real-world T-DXd in Treating Chinese Patients With HER2 Overexpression and HER2 Underexpression Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07035353
- Acronym / sponsor ID
- TDXD2025
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2035 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is an open, prospective study to collect data on the efficacy and safety of T-DXd (DS8201) in Chinese patients with HER2 overexpressing and HER2 underexpressing advanced breast cancer in actual clinical practice in China.
Cohort A:
HER2 overexpressing patients with advanced breast cancer
Cohort B:
HER2 underexpressing patients with advanced breast cancer A total of 400 subjects will be enrolled in the program, with 200 enrolled in Cohort A and 200 enrolled in Cohort B. The study will be conducted by a physician in accordance with current clinical practice. The treatment plan will be recommended to the subjects by the treating physician based on the current clinical practice guidelines in conjunction with the clinical practice, and the patient's decision to be treated with T-DXd (DS8201) should precede enrollment in this study. Because of the non-interventional nature of this study, this study does not alter or interfere with clinician treatment decisions, and the actual medical practice of patients.
Inclusion in the study after the first treatment with the drug is based on inclusion/exclusion criteria. Subject enrollment in this study should be within 2 months of the subject's first dose of medication and prior to the first efficacy assessment. Demographic data, past medical and treatment history, ECOG score, vital signs + physical examination, laboratory tests, objective tumor evaluation, coadministration/concomitant therapy, adverse events, time to progression/death, and subsequent antitumor therapy were collected at baseline, during treatment, and at subsequent follow-up. Imaging evaluation was performed according to RECIST 1.1 criteria. Adverse events evaluation criteria were based on NCI-CTCAE version 5.0.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HER2 overexpression in advanced breast cancer patients | – | Drug: T-DXd (DS8201) 5.4 mg/kg, IVD, 1 cycle every 21 days. |
| Patients with advanced breast cancer with low HER2 expression | – | Drug: T-DXd (DS8201) 5.4 mg/kg, IVD, 1 cycle every 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving T-DXd (DS8201) for HER2 overexpression and HER2 underexpression advanced breast cancer in actual clinical practice in China Chinese patients
Key inclusion criteria (8 listed)
- Must be competent and able to sign and date an Institutional Review Board (IRB) or Ethics Committee (EC)-approved ICF prior to any study-specific procedure or trial.
- Female patients aged ≥18 years with advanced breast cancer who are adults.
- Pathologically confirmed breast cancer that meets the following criteria:
- Patients must have measurable lesions according to RECIST 1.1 criteria.
- Unmenopausal, menopausal, and perimenopausal female patients were allowed to be enrolled.
Key exclusion criteria (4 listed)
- Early stage breast cancer
- Patients who do not meet the criteria for HER2 overexpression and HER2 underexpression.
- Female patients during pregnancy or lactation.
- Patients deemed unsuitable for enrollment by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-DXd (DS8201) 5.4 mg/kg, IVD, 1 cycle every 21 days.The treatment plan will be recommended to the subject by the treating physician in accordance with current clinical practice guidelines and clinical practice, and the patient's decision to receive T-DXd (DS8201) should precede enrollment in this study. The strategy for administering a particular treatment to a subject is not determined a priori by the trial protocol, but should be in accordance with current clinical practice. Because of the non-interventional nature of this study, this study does not alter or interfere with the patient's actual current medical practice. | Drug | HER2 overexpression in advanced breast cancer patients, Patients with advanced breast cancer with low HER2 expression |
Primary outcome
To assess progression-free survival (PFS) of Chinese patients with advanced breast cancer with HER2 overexpression and HER2 underexpression treated with real-world T-DXd (DS8201).
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2 Overexpression and Advanced Stage Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
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 8 inclusion and 4 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 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Weixin Sun ((022)65150123-8212, scarcity0@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess progression-free survival (PFS) of Chinese patients with advanced breast cancer with HER2 overexpression and HER2 underexpression treated with real-world T-DXd (DS8201). (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2025.