Breast cancer
Conditions
Interventions
Cohort 1:Patients will be assigned to Cohort 1 (HER2 IHC 2+) based on different HER2 immunohistochemical expression levels, where they will first receive T-DXd treatment, followed by SG treatment upon
Cohort 1:Patients will be assigned to Cohort 2 (HER2 IHC <= 1+) based on different HER2 immunohistochemical expression levels, where they will first receive SG treatment, followed by T-DXd treatment u
Sponsors
Xi'an International Medical Center Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Adult patients >= 18 years old; (2) Histologically or cytologically confirmed HR+/HER2- (HER2 IHC 0/IHC 1+ or IHC 2+ with FISH-negative) locally advanced unresectable or metastatic breast cancer, as defined by ASCO/CAP guidelines; (3) Prior treatment with CDK4/6i combined with endocrine therapy, with radiologically confirmed disease progression; (4) Presence of evaluable lesions; (5) Received <= 2 lines of chemotherapy for advanced disease; (6) Adequate organ function and performance status (ECOG score <= 2); (7) Signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Previous treatment with topoisomerase 1 (TOP-1) inhibitor-based therapy; (2) Severe cardiac, hepatic, or renal dysfunction or other serious comorbidities; (3) History of moderate to severe interstitial lung disease (ILD) with concurrent pulmonary insufficiency; (4) Symptomatic brain metastases; (5) History of allergy to key components of the investigational ADC drugs (e.g., payload, antibody, or linker); (6) Patients with active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or a history of intestinal obstruction or gastrointestinal (GI) perforation; (7) Uncontrolled cardiovascular diseases (e.g., NYHA Class III/IV heart failure, myocardial infarction within 6 months); (8) Active infections (e.g., HIV, active HBV/HCV infection); (9) Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS1; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS2;PFS;ORR;OS; | — |
Countries
China
Contacts
Public ContactYan Xue
Xi'an International Medical Center Hospital
Outcome results
None listed