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

Breast Cancer Clinical Trial

Official title:

Union Hospital Affiliated to Huazhong University of Science and Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861635
• Other study ID #: UHCT22575
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: February 2023
• Source: Wuhan Union Hospital, China
• Contact: Jing Yao, doctor
• Phone: 02785726375
• Email: jeaneyph[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neoadjuvant Therapy

Intervention

Drug:
• Disitamab Vedotin combined with Tislelizumab
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

Locations

Country	Name	City	State
China	WuhanHU	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete remission (pCR) rate		16 weeks