Treatment for HER2-low advanced breast cancer using Disitamab vedotin
Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer
NA · RenJi Hospital · NCT05831878
This study is testing a new treatment called Disitamab vedotin for people with HER2-low advanced breast cancer who have already tried one round of chemotherapy to see if it can help them feel better and live longer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | RenJi Hospital (other) |
| Drugs / interventions | chemotherapy, Disitamab |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05831878 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are female patients aged 18-70 years with HER2-low advanced breast cancer who have received no more than one previous chemotherapy.
Not a fit: Patients with a history of thromboembolic events, uncontrolled systemic diseases, or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with HER2-low advanced breast cancer who have limited treatment alternatives.
How similar studies have performed: While the specific approach of using Disitamab vedotin for HER2-low advanced breast cancer is novel, similar antibody-drug conjugate strategies have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Breast Cancer