Subjects with HER2-low advanced breast cancer were treated with Disitamab vedotin as salvage treatment. ORR, PFS, OS and AE were assessed during the trial. HER2-low status is defined as IHC1+ or IHC2+ with negative FISH test.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Female patients aged ≥18 years
Expected survival ≥12 weeks
ECOG 0-1
Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable
At least one measurable lesion according to the RECIST 1.1
No history of antibody-drug conjugate use
Up to one previous chemotherapy for advanced disease
Available hormone receptor status. Hormone receptor-positive subjects are allowed to receive no more than two previous endocrine therapy for advanced disease
HER2-low tumors, defined as IHC1+ or IHC2+ with negative FISH test; or HER2-ultralow tumors, defined as incomplete and faint membrane staining in \>0 but ≤10% of tumor cells
Adequate organ function
You may not be if
History of thromboembolic events
Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc.
Active infections requiring systemic treatment
Pregnant or lactating
Presence of brain metastases and/or carcinomatous meningitis
Clareo Health | RC48-ADC in HER2-low Advanced Breast Cancer
