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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
SHR-A1811
DrugSHR-A1811 administered weekly
SHR-A1811
DrugSHR-A1811 administered every two weeks (q2w)
SHR-A1811
DrugSHR-A1811 administered every three weeks (q3w)
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Arm 1: Weekly administration groupExperimental treatment 1 intervention
Group B: Arm 2: Every-two-weeks (Q2W) administration groupExperimental treatment 1 intervention
Group C: Arm 3: Every-three-weeks (Q3W) administration groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment until disease progression or up to 2 yearsSecondary 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.
Time frame
From enrollment until disease progression or up to 2 yearsOther outcomes
1
Overall Survival (OS)
Defined as the time from study enrollment to all-cause death.
Time frame
From enrollment until all-cause death.2
Safety and Tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame
From first dose of study drug up to 30 days after last doseSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: