Not yet recruiting NCT07560475
Exploratory Study of SHR-A1811 Via Different Administration Routes in Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-A1811, SHR-A1811, SHR-A1811.
- Who it may be relevant to
- Registry conditions: HER2positive, Advanced Breast Cancer, HER2 + Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exploratory Study of Efficacy and Safety of Different Administration Routes of SHR-A1811 in Patients With HER2-Positive Advanced Breast Cancer
Overview
An Exploratory Study on the Efficacy and Safety of Different Administration Routes of SHR-A1811 in the Treatment of HER2-Positive Advanced Breast Cancer
Interventions
- Drug SHR-A1811
SHR-A1811 administered weekly - Drug SHR-A1811
SHR-A1811 administered every two weeks (q2w) - Drug SHR-A1811
SHR-A1811 administered every three weeks (q3w)
Primary outcome measures
- Objective Response Rate (ORR) [Time frame: From enrollment until disease progression or up to 2 years]
Secondary outcome measures (1)
- Progression-Free Survival (PFS) [Time frame: From enrollment until disease progression or up to 2 years]
Eligibility criteria
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.
- 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).
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Medical University Cancer Insititute and Hospital — Tianjin
Identifiers
NCT: NCT07560475 · MA-BC-II-145