RC48-ADC in HER2-low Advanced Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2026-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital

Criteria

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