Treatment for HER2-low advanced breast cancer using Disitamab vedotin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of Disitamab vedotin (RC48-ADC) as a salvage treatment for patients with HER2-low advanced breast cancer who have previously received up to one chemotherapy for recurrent or metastatic disease. The study focuses on patients whose tumors are classified as HER2-low, defined by specific immunohistochemistry and FISH test results. Key outcomes assessed include overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events (AE) during the treatment period.

Why it matters

Who can join: the full rules

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

Where it's running

• Renji Hospital, School of Medicine, Shanghai Jiaotong University
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Wenjin Yin, M.D. — Renji Hospital,School of Medicine, Shanghai Jiaotong University
• Study coordinator: Wenjin Yin, M.D.
• Email: yinwenjin@renji.com
• Phone: 86(21)68385569

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.