HER 2 Low-expressing Breast CancerNCT06492447
Correlation Study of Serum HER 2 Against HER 2-ADC Drug Efficacy in HER 2 Low-expressing Breast Cancer
An observational study of HER 2 Low-expressing Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
Breast cancer is one of the most common malignancies in women worldwide, with HER2-positive breast cancer accounting for about 15-20% of all breast cancer cases. HER2 (Human epidermal growth factor receptor 2) is a tyrosine kinase receptor that, when overexpressed, promotes the growth and spread of tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER 2 Low-expressing Breast Cancer
- What is being tested?
- Against HER 2-ADC Drug
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 4 Jul 2024to 4 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Breast cancer patients treated with anti-HER2-ADC drugs
Who may be able to join
- 1. Subjects with pathologically confirmed breast cancer; 2. The therapeutic drugs are anti-HER2-ADC drugs; 3. No history of other tumors; 4. Age > 18 years old; 5. Have relatively complete clinical case characteristics data.
Who cannot join
- 1. Male breast cancer subjects; 2. Suffering from other malignant neoplasms; 3. Subjects with incomplete clinical case characteristics.
Trial locations and contacts
No sites are listed yet.
About this study
Breast cancer is one of the most common malignancies in women worldwide, with HER2-positive breast cancer accounting for about 15-20% of all breast cancer cases. HER2 (Human epidermal growth factor receptor 2) is a tyrosine kinase receptor that, when overexpressed, promotes the growth and spread of tumor cells. The advent of anti-HER2 therapy, particularly antibody-coupled drugs (ADCs), has resulted in significant survival benefits for HER2-positive breast cancer subjects.
At present, the value of serum HER2 in the monitoring of anti-HER2-ADC drug therapy is insufficient. The purpose of this study was to investigate changes in serum HER2 expression levels in breast cancer subjects treated with anti-HER2-ADC drugs and the relationship between these changes and treatment effect. The therapeutic effect of HER2 was evaluated by continuous detection of HER2 serum, which provided a theoretical basis for the selection of clinical drug treatment.
Read the detailed description
ADC drugs are a new type of targeted therapy. ADC drugs are composed of monoclonal antibodies, linkers and drug carriers, which bind to the target antigen on the surface of tumor cells through antibodies, endocytosis/internalization to form early endosomes in cells, and then mature into late endosomes and fuse with lysosomes. ADC drugs break apart in the lysosome and release the drug carrier, eventually leading to apoptosis or death while minimizing damage to normal cells. However, not all subjects with HER2-positive breast cancer respond well to ADC drugs, and resistance may develop during treatment. Therefore, effective biomarkers are needed to monitor treatment effects and guide individualized treatment. Serum HER2 refers to the HER2 protein fragment present in the subject's serum. Serum HER2 levels may be more readily available than HER2 expression in tumor tissue and can be sampled multiple times during treatment, allowing real-time monitoring of disease progression and drug efficacy. If monitoring of serum HER2 levels accurately reflects tumor sensitivity to ADC drugs, it could be a valuable therapeutic monitoring tool.
In view of the excellent efficacy of ADC drugs in HER2-positive and low-expression breast cancer patients, this study intends to judge the therapeutic efficacy of breast cancer patients treated by anti-HER2-ADC drugs (such as T-DXd) through continuous detection of their serum HER2, providing a theoretical basis for the selection of clinical drug therapy.
- Conditions
- HER 2 Low-expressing Breast Cancer
- Being tested
- Against HER 2-ADC Drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Against HER 2-ADC DrugDrug
Breast cancer subjects receiving anti-HER2-ADC drugs were treated with a 3-week treatment cycle lasting 6 cycles. Serum of patients before and after treatment was collected, and the changes of serum HER2 level before chemotherapy and after 2, 4 and 6 cycles of chemotherapy were dynamically monitored, and the relationship between HER2 level and the therapeutic effect of different targeted drugs was analyzed.
| Study group | Role | What they receive |
|---|---|---|
| HER2 low-expressing | Not described Receives: Drug: Against HER 2-ADC Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR) according to RECIST 1.1.
Measured: 1-2 years
Secondary outcomes (1)
PFS
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start4 Jul 2024 (estimated)
- Primary completion4 Jan 2026 (estimated)
- Study completion4 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER 2 Low-expressing 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen New Industries Biomedical Engineering Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492447
- Sponsor's protocol ID
- HR-BLTN-016
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Study of Serum HER 2 Against HER 2-ADC Drug Efficacy in HER 2 Low-expressing Breast Cancer
- ClinicalTrials.gov ID
- NCT06492447
- Acronym / sponsor ID
- HR-BLTN-016
- Conditions
- HER 2 Low-expressing Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Shenzhen New Industries Biomedical Engineering Co., Ltd.
- Study start
- 4 Jul 2024 (estimated)
- Primary completion
- 4 Jan 2026 (estimated)
- Study completion
- 4 Mar 2026 (estimated)
- First posted
- 9 Jul 2024 (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.
Breast cancer is one of the most common malignancies in women worldwide, with HER2-positive breast cancer accounting for about 15-20% of all breast cancer cases. HER2 (Human epidermal growth factor receptor 2) is a tyrosine kinase receptor that, when overexpressed, promotes the growth and spread of tumor cells. The advent of anti-HER2 therapy, particularly antibody-coupled drugs (ADCs), has resulted in significant survival benefits for HER2-positive breast cancer subjects.
At present, the value of serum HER2 in the monitoring of anti-HER2-ADC drug therapy is insufficient. The purpose of this study was to investigate changes in serum HER2 expression levels in breast cancer subjects treated with anti-HER2-ADC drugs and the relationship between these changes and treatment effect. The therapeutic effect of HER2 was evaluated by continuous detection of HER2 serum, which provided a theoretical basis for the selection of clinical drug treatment.
Detailed description
ADC drugs are a new type of targeted therapy. ADC drugs are composed of monoclonal antibodies, linkers and drug carriers, which bind to the target antigen on the surface of tumor cells through antibodies, endocytosis/internalization to form early endosomes in cells, and then mature into late endosomes and fuse with lysosomes. ADC drugs break apart in the lysosome and release the drug carrier, eventually leading to apoptosis or death while minimizing damage to normal cells. However, not all subjects with HER2-positive breast cancer respond well to ADC drugs, and resistance may develop during treatment. Therefore, effective biomarkers are needed to monitor treatment effects and guide individualized treatment. Serum HER2 refers to the HER2 protein fragment present in the subject's serum. Serum HER2 levels may be more readily available than HER2 expression in tumor tissue and can be sampled multiple times during treatment, allowing real-time monitoring of disease progression and drug efficacy. If monitoring of serum HER2 levels accurately reflects tumor sensitivity to ADC drugs, it could be a valuable therapeutic monitoring tool.
In view of the excellent efficacy of ADC drugs in HER2-positive and low-expression breast cancer patients, this study intends to judge the therapeutic efficacy of breast cancer patients treated by anti-HER2-ADC drugs (such as T-DXd) through continuous detection of their serum HER2, providing a theoretical basis for the selection of clinical drug therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2 low-expressing | – | Drug: Against HER 2-ADC Drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients treated with anti-HER2-ADC drugs
Key inclusion criteria (1 listed)
- 1. Subjects with pathologically confirmed breast cancer; 2. The therapeutic drugs are anti-HER2-ADC drugs; 3. No history of other tumors; 4. Age > 18 years old; 5. Have relatively complete clinical case characteristics data.
Key exclusion criteria (1 listed)
- 1. Male breast cancer subjects; 2. Suffering from other malignant neoplasms; 3. Subjects with incomplete clinical case characteristics.
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 |
|---|---|---|
| Against HER 2-ADC DrugBreast cancer subjects receiving anti-HER2-ADC drugs were treated with a 3-week treatment cycle lasting 6 cycles. Serum of patients before and after treatment was collected, and the changes of serum HER2 level before chemotherapy and after 2, 4 and 6 cycles of chemotherapy were dynamically monitored, and the relationship between HER2 level and the therapeutic effect of different targeted drugs was analyzed. | Drug | HER2 low-expressing |
Primary outcome
Objective Response Rate
Time frame: 1-2 years
Percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR) according to RECIST 1.1.
1 secondary outcome
PFS
Time frame: 1-2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for HER 2 Low-expressing Breast Cancer
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Breast Cancer
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of HER 2 Low-expressing 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 1 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: status not confirmed, as of the sponsor's last update on 9 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yehui Shi, PhD (+8618622221183, shiyehui@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 1-2 years). 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 9 Jul 2024.