Combining vidicizumab and tirelizumab for treating low HER2 breast cancer

Union Hospital Affiliated to Huazhong University of Science and Technology

This study is testing if a combination of two drugs, vidicizumab and tirelizumab, can help improve treatment outcomes for patients with early high-risk breast cancer that has low HER2 levels before surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Wuhan Union Hospital, China (Academic / other)
• Drugs / interventions: vidicizumab, tirelizumab, immunotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05861635 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of vidicizumab in combination with tirelizumab for patients with early high-risk or locally advanced breast cancer that has low HER2 expression. The study aims to determine if this combination can serve as a new neoadjuvant treatment option, potentially improving patient outcomes. Participants will receive these treatments prior to surgery, with the goal of enhancing their prognosis and quality of life. The trial focuses on patients who meet specific criteria regarding their cancer stage and HER2 expression levels.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with early or locally advanced breast cancer and low HER2 expression.

Not a fit: Patients with stage IV breast cancer or those who have received recent anti-tumor treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with low HER2 expression breast cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches in treating low HER2 expression breast cancer, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age: 18 to 75 years old, male or female;
2. Early or locally advanced breast cancer confirmed by pathology;
3. Lymph node positive or lymph node negative, ER and PR negative, T ≥ 2 or lymph node negative, ER positive or PR positive, T ≥ 5;
4. ECOG PS: 0-1; 5）Patients with low expression of HER-2: HER-2 IHC 1+or HER2 IHC 2+and ISH negative;

Exclusion Criteria:

1. Stage IV breast cancer;
2. Have received anti-tumor treatment or radiotherapy for any malignant tumor in the past five years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma;
3. At the same time, other clinical trials have received anti-tumor therapy. If the researcher judges that the patient cannot benefit from the researcher, other anti-tumor therapy can be ended.
4. The patient has undergone major surgery unrelated to breast cancer within 4 weeks before enrollment, or has not fully recovered from such surgery;
5. Previously received ADC drugs, immunosuppressants, anti-HER2 and other treatments.

Where this trial is running

Wuhan, Hubei

• WuhanHU — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Jing Yao, doctor

Conditions Breast Cancer; Neoadjuvant Therapy