HER2positivePhase 2NCT07560475
Exploratory Study of SHR-A1811 Via Different Administration Routes in Patients
A Phase 2 study testing SHR-A1811 in people with HER2positive and Advanced Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
An Exploratory Study on the Efficacy and Safety of Different Administration Routes of SHR-A1811 in the Treatment of HER2-Positive Advanced Breast Cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2positive, Advanced Breast Cancer, HER2 + Breast Cancer
- What is being tested?
- SHR-A1811
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2026to 31 Dec 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years old.
- Pathologically confirmed HER2-positive advanced breast cancer. HER2 positivity is defined as IHC 3+ in >10% immunoreactive cells or HER2 gene amplification confirmed by in situ hybridization (ISH), which shall be verified by the pathology department of the participating center.
- Patients with advanced breast cancer who have received no more than 2 lines of prior systemic therapies.
- Expected survival time ≥ 4 months.
- Have at least one measurable lesion per RECIST 1.1 criteria (helical CT scan lesion diameter ≥ 10 mm with slice thickness ≤ 5 mm).
- Adequate major organ function without blood transfusion.
- Voluntarily participate in the study, sign informed consent form, with good compliance and willingness to complete follow-up visits.
Who cannot join
- Prior treatment with anti-HER2 antibody-drug conjugates (ADC).
- Known leptomeningeal metastasis or active brain metastasis.
- A history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ, cutaneous basal cell carcinoma and squamous cell carcinoma. Malignancies cured solely by surgery more than 5 years prior to enrollment are allowed.
- Major surgery or severe trauma within 4 weeks before enrollment, or planned major surgery during the study period.
- Participation in other investigational new drug clinical trials within 4 weeks prior to enrollment.
- Presence of hereditary bleeding tendency or coagulation disorders.
Show all 14Show fewer
- Uncontrolled hypertension with systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg despite standard antihypertensive therapy.
- A history of clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, active pneumonia, pulmonary fibrosis and radiation pneumonitis (excluding asymptomatic post-radiation changes without treatment requirement).
- A history of severe cardiac diseases or uncontrolled cardiac conditions, including NYHA class II or higher cardiac insufficiency, unstable angina, myocardial infarction within one year, and arrhythmias requiring clinical intervention.
- Conditions affecting drug intake and absorption, such as dysphagia, chronic diarrhea and intestinal obstruction.
- Known allergy to any component of the study drugs.
- Uncontrolled pleural effusion or ascites that cannot be relieved by drainage or other clinical interventions.
- Severe uncontrolled comorbidities, including immune deficiency disorders (e.g. HIV positivity, history of organ transplantation), active hepatitis B or hepatitis C, and severe ongoing infections requiring systemic anti-infective treatment.
- Any other conditions considered inappropriate for study enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Cancer Insititute and Hospital
Tianjin, 300060
About this study
Official title: Exploratory Study of Efficacy and Safety of Different Administration Routes of SHR-A1811 in Patients With HER2-Positive Advanced Breast Cancer
An Exploratory Study on the Efficacy and Safety of Different Administration Routes of SHR-A1811 in the Treatment of HER2-Positive Advanced Breast Cancer
- Conditions
- HER2positive, Advanced Breast Cancer, HER2 + Breast Cancer
- Being tested
- SHR-A1811
- 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
SHR-A1811 administered weekly
SHR-A1811Drug
SHR-A1811 administered every two weeks (q2w)
SHR-A1811Drug
SHR-A1811 administered every three weeks (q3w)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Weekly administration group | Experimental | Not described Receives: Drug: SHR-A1811 |
| Arm 2: Every-two-weeks (Q2W) administration group | Experimental | Not described Receives: Drug: SHR-A1811 |
| Arm 3: Every-three-weeks (Q3W) administration group | Experimental | Not described Receives: Drug: SHR-A1811 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Defined as the proportion of patients who achieve confirmed complete response (CR) or partial response (PR) to the study treatment, assessed per RECIST 1.1 criteria.
Measured: From enrollment until disease progression or up to 2 years
Secondary outcomes (1)
Progression-Free Survival (PFS)
Defined as the time from study enrollment to the first documentation of disease progression (per RECIST 1.1) or all-cause death, whichever occurs first.
Measured: From enrollment until disease progression or up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start10 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2positiveStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560475
- Sponsor's protocol ID
- MA-BC-II-145
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 11 Jun 2026
- 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Efficacy and Safety of Different Administration Routes of SHR-A1811 in Patients With HER2-Positive Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07560475
- Acronym / sponsor ID
- MA-BC-II-145
- Conditions
- HER2positive, Advanced Breast Cancer, HER2 + Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 May 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.
An Exploratory Study on the Efficacy and Safety of Different Administration Routes of SHR-A1811 in the Treatment of HER2-Positive Advanced Breast Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Weekly administration group | Experimental | Drug: SHR-A1811 |
| Arm 2: Every-two-weeks (Q2W) administration group | Experimental | Drug: SHR-A1811 |
| Arm 3: Every-three-weeks (Q3W) administration group | Experimental | Drug: SHR-A1811 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥ 18 years old.
- Pathologically confirmed HER2-positive advanced breast cancer. HER2 positivity is defined as IHC 3+ in >10% immunoreactive cells or HER2 gene amplification confirmed by in situ hybridization (ISH), which shall be verified by the pathology department of the participating center.
- Patients with advanced breast cancer who have received no more than 2 lines of prior systemic therapies.
- Expected survival time ≥ 4 months.
- Have at least one measurable lesion per RECIST 1.1 criteria (helical CT scan lesion diameter ≥ 10 mm with slice thickness ≤ 5 mm).
Key exclusion criteria (14 listed)
- Prior treatment with anti-HER2 antibody-drug conjugates (ADC).
- Known leptomeningeal metastasis or active brain metastasis.
- A history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ, cutaneous basal cell carcinoma and squamous cell carcinoma. Malignancies cured solely by surgery more than 5 years prior to enrollment are allowed.
- Major surgery or severe trauma within 4 weeks before enrollment, or planned major surgery during the study period.
- Participation in other investigational new drug clinical trials within 4 weeks prior to enrollment.
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-A1811SHR-A1811 administered weekly | Drug | Arm 1: Weekly administration group |
| SHR-A1811SHR-A1811 administered every two weeks (q2w) | Drug | Arm 2: Every-two-weeks (Q2W) administration group |
| SHR-A1811SHR-A1811 administered every three weeks (q3w) | Drug | Arm 3: Every-three-weeks (Q3W) administration group |
Primary outcome
Objective Response Rate (ORR)
Time frame: From enrollment until disease progression or up to 2 years
Defined as the proportion of patients who achieve confirmed complete response (CR) or partial response (PR) to the study treatment, assessed per RECIST 1.1 criteria.
1 secondary outcome
Progression-Free Survival (PFS)
Time frame: From enrollment until disease progression or up to 2 years
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 11 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for HER2positive
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-A1811 in people with HER2positive and Advanced Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site 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 7 inclusion and 14 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 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Objective Response Rate (ORR) (time frame: From enrollment until disease progression or up to 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 11 Jun 2026.