Exploratory Study of SHR-A1811 Via Different Administration Routes in Patients
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital
About this trial
An Exploratory Study on the Efficacy and Safety of Different Administration Routes of SHR-A1811 in the Treatment of HER2-Positive Advanced Breast Cancer
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SHR-A1811
- SHR-A1811
- SHR-A1811
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov