Recruiting
RC48-ADC in HER2-low Advanced Breast Cancer
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.
ClinicalTrials.gov IDNCT05831878
PhaseNA
Enrollment36
SponsorRenJi Hospital
Age18 Years
SexFEMALE
Conditions studied
Advanced Breast Cancer
About this study
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.
Interventions
- Drug: Disitamab vedotin — 2.0mg/kg, iv, day1, every 2 weeks
Primary outcomes
- Objective Response Rate (ORR) (From the date of starting Disitamab Vedotin to the date of first documentation of progression or death (up to approximately 1 year))
Eligibility information
Inclusion Criteria:
* 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 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
Study locations
- Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200127 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.