RecruitingNot ApplicableNCT05831878
RC48-ADC in HER2-low Advanced Breast Cancer
Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer
Sponsor
RenJi Hospital
Enrollment
36 participants
Start Date
May 4, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria10
- 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
Exclusion Criteria5
- 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
Interventions
DRUGDisitamab vedotin
2.0mg/kg, iv, day1, every 2 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05831878
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