Overview
To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.
Description
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.
Eligibility
Inclusion Criteria:
- Female patients aged 18-70 years (including 18 years and 70 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
- Adequate organ function
Exclusion Criteria:
- 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