The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of vidicizumab combined with tirelizumab in the treatment of early high-risk or locally advanced breast cancer with low HER2 expression

Detailed Description
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Studies have shown that vidicizumab has good efficacy and safety in advanced HER-2 low expression breast cancer. Vidicizumab combined with immunotherapy may be a new adjuvant treatment option for HER-2 low expression breast cancer patients. Therefore, we plan to carry out a clinical study to evaluate the efficacy, safety and tolerance of vidicizumab combined with tirelizumab during neoadjuvant therapy, in order to provide new treatment options for patients with breast cancer with HER-2 low expression in neoadjuvant therapy, improve their prognosis and improve their quality of life

Official Title
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Union Hospital Affiliated to Huazhong University of Science and Technology

Conditions
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Breast Cancer, Neoadjuvant Therapy

Intervention / Treatment
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* Drug: Disitamab Vedotin combined with Tislelizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 to 75 years old, male or female; Early or locally advanced breast cancer confirmed by pathology; Lymph node positive or lymph node negative, ER and PR negative, T ≥ 2 or lymph node negative, ER positive or PR positive, T ≥ 5; 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: Stage IV breast cancer; 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; 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. The patient has undergone major surgery unrelated to breast cancer within 4 weeks before enrollment, or has not fully recovered from such surgery; Previously received ADC drugs, immunosuppressants, anti-HER2 and other treatments.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disitamab Vedotin combined with Tislelizumab<br>Subjects who meet the requirements of the protocol will receive neoadjuvant treatment, and the specific administration arrangement is as follows: Disitamab Vedotin, 2 mg/Kg, q2W, 8cycle Tislelizumab, 200mg, iv, q3W, 6cycle | Drug: Disitamab Vedotin combined with Tislelizumab<br>* Subjects who meet the requirements of the protocol will receive neoadjuvant treatment, and the specific administration arrangement is as follows: Disitamab Vedotin, 2 mg/Kg, q2W, 8cycle Tislelizumab, 200mg, iv, q3W, 6cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete remission (pCR) rate |  | 16 weeks |