RC48-ADC in HER2-low Advanced Breast Cancer

Recruiting now · Not applicable

Conditions studied: Advanced Breast Cancer

In brief

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.

Key facts

Study ID

NCT05831878

Run by

RenJi Hospital

People needed

36

Starts

2023-05-04

Expected to finish

2027-12-01

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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