About this trial
This study is a phase II clinical trial of SSGJ-612 combined with a human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate (ADC) in patients with hormone receptor (HR)-positive, HER2-low or HER2-ultralow metastatic breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary participation in this study, signed informed consent form, good treatment compliance, and willingness to cooperate to complete all trial procedures.
Expected survival duration ≥ 3 months.
Metastatic tumor;
Tumor samples tested by central laboratory confirmed as HER2-low or HER2 ultra-low expression;
Disqualifiers
Uncontrolled or severe cardiovascular disease.
History of interstitial lung disease (ILD)/pneumonia requiring corticosteroid therapy (non-infectious), or current ILD/pneumonia, or suspected ILD/pneumonia not excluded by screening imaging.
Presence of pulmonary-specific, clinically significant comorbid conditions.
Presence of spinal cord compression, or clinically active central nervous system metastases.
Trial design
Parallel
Treatments tested in this trial
SSGJ-612 (HER2-targeted antibody)
DrugIntravenous injection
HER2-targeted ADC
DrugIntravenous injection
Treatment groups
Trial outcomes
Primary outcomes
Objective Response Rate (ORR)
The primary efficacy end point
Secondary outcomes
Incidence and Severity of Adverse Events (AEs)
The secondary safety end point
Progression-Free-Survival (PFS)
The secondary efficacy end point
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: