Patients With Low HER2 Expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 Advanced Breast CancerNCT07670182
The Efficacy of Combined Peripheral Blood CTCs and Serum HER2 Detection in Docetaxel-based Treatment for HER2 Low-expression Breast Cancer
An observational study of Patients With Low HER2 Expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 Advanced Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This study is a multicenter, double-cohort clinical research aimed at systematically evaluating the value of jointly detecting the HER2 expression of CTCs/CTECs and the serum HER2 ECD level in predicting the efficacy of T-DXd treatment for patients with HER2 low expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patients With Low HER2 Expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 Advanced Breast Cancer
- What is being tested?
- Anti-HER2-ADC drug Deruxtepracabine
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 1 Jan 2031
- 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: This study focused on breast cancer patients who had received treatment with anti-HER2-ADC drugs.
Who may be able to join
- Patients with a pathological record of breast cancer;
- Group A: Diagnosed with low expression of HER2 (IHC 1+ or IHC 2+ and ISH-); Group B: Diagnosed with HER2 0 expression (IHC 0);
- No history of other malignant tumors;
- Signed the informed consent form at the age of 18 or above;
- Possess relatively complete clinical case characteristic data.
Who cannot join
- 1. Male breast cancer patients; 2. Pregnant or breastfeeding; 3. Patients known to have an allergic reaction to the active substances or any excipients of T-DXd; 4. Patients judged by the investigators to be unsuitable to participate in this study.
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 Prospective, Multicenter Clinical Study on the Efficacy Correlation of Deruxtepruzumab Treatment for Advanced Breast Cancer With Low/Ultra-low HER2 Expression, Guided by Peripheral Blood CTCs/CTECs Combined With Serum HER2 Detection
This study is a multicenter, double-cohort clinical research aimed at systematically evaluating the value of jointly detecting the HER2 expression of CTCs/CTECs and the serum HER2 ECD level in predicting the efficacy of T-DXd treatment for patients with HER2 low expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 advanced breast cancer.
Read the detailed description
The study plans to include 100 patients and divide them into cohort A (HER2 low expression, 70 cases) and cohort B (HER2 IHC 0, 30 cases) based on the tissue HER2 status. This study adopts a non-random design, and patients will be directly included in the corresponding cohort according to their baseline tissue HER2 status. All enrolled patients will receive standard T-DXd treatment after signing the informed consent form until disease progression, occurrence of intolerable toxic reactions, or study termination. The primary endpoint of the study is to explore the correlation between the HER2 expression status of CTCs/CTECs and ORR. The secondary endpoints include the correlation between the baseline HER2 expression status of CTCs/CTECs and the DCR, PFS, and OS of the entire population; the correlation between the baseline serum HER2 ECD level and the ORR, DCR, PFS, and OS of the entire population; and the ORR and PFS of each cohort. Patients will be followed up from the first administration and samples of peripheral blood will be collected for biomarker dynamic monitoring before treatment, at 2 cycles of treatment, and at the time of disease progression (the number of tests may be increased or decreased according to the patient's condition) until disease progression, death, loss to follow-up, or study closure.
- Conditions
- Patients With Low HER2 Expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 Advanced Breast Cancer
- Being tested
- Anti-HER2-ADC drug Deruxtepracabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-HER2-ADC drug DeruxtepracabineDrug
Also called Other medications: The doctor will determine the administration plan based on the specific circumstances.
By monitoring the levels of CTCs/CTECs and serum HER2 expression in breast cancer patients receiving anti-HER2-ADC treatment during the treatment process, we aim to determine the therapeutic monitoring value of CTCs/CTECs and serum HER2 in these breast cancer patients using anti-HER2-ADC drugs.
| Study group | Role | What they receive |
|---|---|---|
| Low expression of HER2 | Patients with low HER2 expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 advanced breast cancer Receives: Drug: Anti-HER2-ADC drug Deruxtepracabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the correlation between the HER2 expression status of baseline CTCs/CTECs and the overall response rate (ORR) of the entire population.
Evaluate the correlation between the HER2 expression status of baseline CTCs/CTECs and the overall population's DCR, PFS, and OS. Evaluate the correlation between the baseline serum HER2 ECD level and the overall population's ORR, DCR, PFS, and OS.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Low HER2 Expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 Advanced Breast CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yehui Shi, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670182
- Sponsor's protocol ID
- BC-HER2 test
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Study on the Efficacy Correlation of Deruxtepruzumab Treatment for Advanced Breast Cancer With Low/Ultra-low HER2 Expression, Guided by Peripheral Blood CTCs/CTECs Combined With Serum HER2 Detection
- ClinicalTrials.gov ID
- NCT07670182
- Acronym / sponsor ID
- BC-HER2 test
- Conditions
- Patients With Low HER2 Expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 Advanced Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 26 Jun 2026 (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.
This study is a multicenter, double-cohort clinical research aimed at systematically evaluating the value of jointly detecting the HER2 expression of CTCs/CTECs and the serum HER2 ECD level in predicting the efficacy of T-DXd treatment for patients with HER2 low expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 advanced breast cancer.
Detailed description
The study plans to include 100 patients and divide them into cohort A (HER2 low expression, 70 cases) and cohort B (HER2 IHC 0, 30 cases) based on the tissue HER2 status. This study adopts a non-random design, and patients will be directly included in the corresponding cohort according to their baseline tissue HER2 status. All enrolled patients will receive standard T-DXd treatment after signing the informed consent form until disease progression, occurrence of intolerable toxic reactions, or study termination. The primary endpoint of the study is to explore the correlation between the HER2 expression status of CTCs/CTECs and ORR. The secondary endpoints include the correlation between the baseline HER2 expression status of CTCs/CTECs and the DCR, PFS, and OS of the entire population; the correlation between the baseline serum HER2 ECD level and the ORR, DCR, PFS, and OS of the entire population; and the ORR and PFS of each cohort. Patients will be followed up from the first administration and samples of peripheral blood will be collected for biomarker dynamic monitoring before treatment, at 2 cycles of treatment, and at the time of disease progression (the number of tests may be increased or decreased according to the patient's condition) until disease progression, death, loss to follow-up, or study closure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low expression of HER2 | – | Drug: Anti-HER2-ADC drug DeruxtepracabinePatients with low HER2 expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 advanced breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study focused on breast cancer patients who had received treatment with anti-HER2-ADC drugs.
Key inclusion criteria (5 listed)
- Patients with a pathological record of breast cancer;
- Group A: Diagnosed with low expression of HER2 (IHC 1+ or IHC 2+ and ISH-); Group B: Diagnosed with HER2 0 expression (IHC 0);
- No history of other malignant tumors;
- Signed the informed consent form at the age of 18 or above;
- Possess relatively complete clinical case characteristic data.
Key exclusion criteria (1 listed)
- 1. Male breast cancer patients; 2. Pregnant or breastfeeding; 3. Patients known to have an allergic reaction to the active substances or any excipients of T-DXd; 4. Patients judged by the investigators to be unsuitable to participate in this study.
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 |
|---|---|---|
| Anti-HER2-ADC drug DeruxtepracabineAlso: Other medications: The doctor will determine the administration plan based on the specific circumstances.By monitoring the levels of CTCs/CTECs and serum HER2 expression in breast cancer patients receiving anti-HER2-ADC treatment during the treatment process, we aim to determine the therapeutic monitoring value of CTCs/CTECs and serum HER2 in these breast cancer patients using anti-HER2-ADC drugs. | Drug | Low expression of HER2 |
Primary outcome
Evaluate the correlation between the HER2 expression status of baseline CTCs/CTECs and the overall response rate (ORR) of the entire population.
Time frame: through study completion, an average of 2 year
Evaluate the correlation between the HER2 expression status of baseline CTCs/CTECs and the overall population's DCR, PFS, and OS. Evaluate the correlation between the baseline serum HER2 ECD level and the overall population's ORR, DCR, PFS, and OS.
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 26 Jun 2026.
- Individual participant dataSharing planned: No
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 Patients With Low HER2 Expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 Advanced 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 5 inclusion and 1 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 26 Jun 2026. 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 Yehui Shi Yehui Shi, Doctor of Medicine (+8618622221183, shiyehui@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the correlation between the HER2 expression status of baseline CTCs/CTECs and the overall response rate (ORR) of the entire population. (time frame: through study completion, an average of 2 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 26 Jun 2026.