This is a prospective, multicenter, randomized controlled study aimed at evaluating the efficacy and safety of Trop2-ADC monotherapy or immune combination strategy in the treatment of advanced triple-negative breast cancer.
This prospective, multicenter, randomized controlled study aims to evaluate the 3-month treatment efficacy (ORR) of three therapeutic strategies-ADC monotherapy, ADC in combination with immunotherapy, and ADC in combination with immunotherapy and anti-angiogenesis-in patients with advanced breast cancer, and to assess potential adverse events related to the treatment regimens. Participants will receive treatment with a Trop-2-targeting ADC drug containing a TOP1 inhibitor (such as Gosituzumab or SKB264), in accordance with the defined protocol. Regular assessments will include imaging, histopathological analysis, and safety monitoring. The objective of this study is to provide novel treatment strategies for triple-negative breast cancer by evaluating the efficacy and safety of trop2-ADC+ immunotherapy + antiangiogenic agents and trop2-ADC+ antiangiogenic agents versus trop2-ADC monotherapy in patients with metastatic triple-negative breast cancer (mTNBC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Accept ADC monotherapy
Accept ADC combined with anti-angiogenic drug
ADC combined with PD1 monoclonal antibody and anti-angiogenic drug
Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China;
Guangzhou, Guangdong, China
RECRUITINGObjective response rate 3 months after treatment (ORR)
Time frame: Three months after enrollment
Overall survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
living quality
The scores of EORTC-c30 scale were compared before and after enrollment.
Time frame: "through study completion, an average of 1 year
Clinical benefit rate
Time frame: 3 months after enrollment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.