Early Breast CancerPhase 2NCT07129187
SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response
A Phase 2 study testing SHR-A1811 in people with Early Breast Cancer and HER2 + Breast Cancer, run by Chuan Wang.
Trial summary
This is an open-label, single-arm, multicenter clinical study to evaluate the efficacy and safety of SHR-A1811 in early or locally advanced HER2-positive breast cancer patients with suboptimal response to neoadjuvant regimen. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Early Breast Cancer, HER2 + Breast Cancer, Stage II Breast Cancer
- What is being tested?
- SHR-A1811
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Oct 2030
- Phase
- Phase 2
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Female patients with newly diagnosed breast cancer aged 18 to 70 years old;
- 2.Early or locally advanced HER2-positive invasive breast cancer;
- 3.Known hormone receptor status;
- 4.ECOG score of 0-1;
- 5.Patients who were determined by the researchers to have poor therapeutic effect after 4 cycles of neoadjuvant therapy;
- 6.Organ function levels must meet the following requirements:
- 7.Women of childbearing age must undergo a serum pregnancy test within 7 days before enrollment, with a negative result, and be willing to use a medically approved highly effective contraceptive method during the study and within 3 months after the last administration of the study drug.
- 8.The subjects voluntarily participate in this study and sign the informed consent form.
Who cannot join
- 1. Patients with metastatic or bilateral breast cancer, or inflammatory breast cancer
- 2. Patients with grade 3 or higher thrombocytopenia during previous treatment, or grade 3 or higher nausea and vomiting despite primary prevention
- 3. History of other malignant tumors (except cured carcinoma in situ of the cervix, basal cell carcinoma, etc.) and related treatment history
- 4. Patients who received major non-breast cancer surgery within 4 weeks before enrollment and have not recovered (except biopsy and PICC)
- 5. Autoimmune diseases (except special cases such as hypothyroidism and stable type 1 diabetes)
- 6. Interstitial lung disease, non-infectious pneumonia, uncontrolled systemic diseases
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- 7. History of or planned administration of live attenuated vaccines within 28 days
- 8. HIV infection, active hepatitis (hepatitis B, hepatitis C, etc.), autoimmune hepatitis
- 9. Severe infection within 4 weeks, CTCAE grade ≥ 2 active infection within 2 weeks (except neoplastic fever), or evidence of active tuberculosis within 1 year
- 10. History of allogeneic bone marrow or solid organ transplantation
- 11. Peripheral neuropathy of grade ≥ 2
- 12. Severe heart diseases
- 13. Receipt of systemic immunostimulant therapy within 4 weeks
- 14. Receipt of systemic immunosuppressant therapy within 2 weeks (except local or physiological dose of hormones)
- 15. Allergy to study drugs/excipients, or history of severe allergic reaction to other monoclonal antibodies
- 16. Pregnant or lactating women; fertile women with positive pregnancy test or unwilling to take effective contraception throughout the trial
- 17. History of neurological/psychiatric disorders , or history of substance abuse, alcoholism, or drug addiction
- 18. Other circumstances deemed unsuitable for enrollment by the researcher
About this study
Official title: An Open-label, Single-arm, Multicenter Study of SHR-A1811 as Neoadjuvant Therapy in HER2-positive Breast Cancer Patients With Suboptimal Neoadjuvant Response
This is an open-label, single-arm, multicenter clinical study to evaluate the efficacy and safety of SHR-A1811 in early or locally advanced HER2-positive breast cancer patients with suboptimal response to neoadjuvant regimen. Patients who were determined by the researchers to have poor therapeutic effect will switch to SHR-A1811.
Read the detailed description
Patients will receive SHR-A1811, until completion or treatment discontinuation due to progression, toxicity, or withdrawal. The primary endpoint is tpCR (ypT0/is ypN0). Secondary endpoints include bpCR, RCB, EFS, and safety. The study will recruit 30 eligible patients from multiple centers in China.
- Conditions
- Early Breast Cancer, HER2 + Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
- Being tested
- SHR-A1811
- Keywords
- neoadjuvant therapy, antibody drug conjugate, SHR-A1811, suboptimal response
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
Drug: SHR-A1811 4.8mg/kg
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 | Experimental | Not described Receives: Drug: SHR-A1811 |
What is being measured
The primary outcome is the main question the study is designed to answer.
tpCR
It is defined as the absence of residual invasive carcinoma in the resected breast cancer specimens stained with hematoxylin and eosin, and no cancer metastasis in all ipsilateral lymph node samples, after completion of neoadjuvant therapy and surgery.
Measured: immediately after surgery
Secondary outcomes (3)
Breast Pathological Complete Response
It is defined as the absence of residual invasive carcinoma in the primary breast lesion after neoadjuvant therapy, with the permission of residual ductal carcinoma in situ within the primary breast lesion.
Measured: immediately after surgery
event free survival
Measured: until the end of the study
residual cancer burden
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Breast CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuan Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chuan Wang, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129187
- Sponsor's protocol ID
- MA-BC-II-124
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 26 Aug 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 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Multicenter Study of SHR-A1811 as Neoadjuvant Therapy in HER2-positive Breast Cancer Patients With Suboptimal Neoadjuvant Response
- ClinicalTrials.gov ID
- NCT07129187
- Acronym / sponsor ID
- MA-BC-II-124
- Conditions
- Early Breast Cancer, HER2 + Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
- Keywords
- neoadjuvant therapy, antibody drug conjugate, SHR-A1811, suboptimal response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chuan WangUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 19 Aug 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.
This is an open-label, single-arm, multicenter clinical study to evaluate the efficacy and safety of SHR-A1811 in early or locally advanced HER2-positive breast cancer patients with suboptimal response to neoadjuvant regimen. Patients who were determined by the researchers to have poor therapeutic effect will switch to SHR-A1811.
Detailed description
Patients will receive SHR-A1811, until completion or treatment discontinuation due to progression, toxicity, or withdrawal. The primary endpoint is tpCR (ypT0/is ypN0). Secondary endpoints include bpCR, RCB, EFS, and safety. The study will recruit 30 eligible patients from multiple centers in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811 | Experimental | Drug: SHR-A1811 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1.Female patients with newly diagnosed breast cancer aged 18 to 70 years old;
- 2.Early or locally advanced HER2-positive invasive breast cancer;
- 3.Known hormone receptor status;
- 4.ECOG score of 0-1;
- 5.Patients who were determined by the researchers to have poor therapeutic effect after 4 cycles of neoadjuvant therapy;
Key exclusion criteria (18 listed)
- 1. Patients with metastatic or bilateral breast cancer, or inflammatory breast cancer
- 2. Patients with grade 3 or higher thrombocytopenia during previous treatment, or grade 3 or higher nausea and vomiting despite primary prevention
- 3. History of other malignant tumors (except cured carcinoma in situ of the cervix, basal cell carcinoma, etc.) and related treatment history
- 4. Patients who received major non-breast cancer surgery within 4 weeks before enrollment and have not recovered (except biopsy and PICC)
- 5. Autoimmune diseases (except special cases such as hypothyroidism and stable type 1 diabetes)
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 |
|---|---|---|
| SHR-A1811Drug: SHR-A1811 4.8mg/kg | Drug | SHR-A1811 |
Primary outcome
tpCR
Time frame: immediately after surgery
It is defined as the absence of residual invasive carcinoma in the resected breast cancer specimens stained with hematoxylin and eosin, and no cancer metastasis in all ipsilateral lymph node samples, after completion of neoadjuvant therapy and surgery.
3 secondary outcomes
Breast Pathological Complete Response
Time frame: immediately after surgery
event free survival
Time frame: until the end of the study
residual cancer burden
Time frame: immediately after surgery
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 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-A1811 in people with Early Breast Cancer and HER2 + Breast Cancer, run by Chuan Wang.
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 18 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 Aug 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tpCR (time frame: immediately after surgery). 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 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.