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.
The study is divided into two parts: Participants in Part 1: Breast cancer patients who have received at least one line of chemotherapy for metastatic disease; Participants in Part 2: Breast cancer patients who have not received any chemotherapy for metastatic disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Intravenous injection
Intravenous injection
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Objective Response Rate (ORR)
The primary efficacy end point
Time frame: 2 years
Incidence and Severity of Adverse Events (AEs)
The secondary safety end point
Time frame: 2 years
Progression-Free-Survival (PFS)
The secondary efficacy end point
Time frame: 2 years
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