NCT05831878Recruiting
RC48-ADC in HER2-low Advanced Breast Cancer
Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 16 Apr 2023
- Start date
- 4 May 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- RenJi Hospital
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05831878
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 4 May 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of thromboembolic events
- Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc.
- Active infections requiring systemic treatment
Other
- Pregnant or lactating
- Presence of brain metastases and/or carcinomatous meningitis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiaotong University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.