Exploratory Study of SHR-A1811 Via Different Administration Routes in Patients (NCT07560475) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Exploratory Study of SHR-A1811 Via Different Administration Routes in Patients
China60 participantsStarted 2026-06-10
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1SHR-A1811 is being studied in different administration routes in this trial — what are those routes, and based on what my doctor knows so far, are there meaningful differences in how they might work or feel for a patient like me?
2Since this is a Phase 2 trial and it's not yet recruiting, how much do we already know about SHR-A1811's safety profile from earlier studies, and what side effects should I be most aware of before deciding whether to wait for this trial to open?
3The trial is measuring objective response rate as its main goal — can you help me understand what that means in practice, and how this compares to the response rates I might expect from HER2-positive breast cancer treatments that are already approved?
4Given that this trial is not yet recruiting, how long might I realistically wait before I could even enroll, and would waiting potentially affect my treatment options or disease progression in the meantime?
5Are there currently approved or standard treatments for HER2-positive advanced breast cancer that I should consider starting now, and how would starting one of those affect my eligibility if I later wanted to join this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From enrollment until disease progression or up to 2 years
Trial details
NCT IDNCT07560475
SponsorTianjin Medical University Cancer Institute and Hospital
. 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.
. 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).