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

NCT ID: NCT05861635

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2026-02-01

Brief 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

Detailed 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

Conditions

Breast Cancer; Neoadjuvant Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Disitamab Vedotin combined with Tislelizumab

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing Yao

Role: STUDY_DIRECTOR

Xiehe Hospital

Locations

WuhanHU

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jing Yao, doctor

Role: CONTACT

jeaneyph@163.com

02785726375

Facility Contacts

Jing Yao

Role: primary

jeaneyph@163.com

02785726375

Other Identifiers

UHCT22575

Identifier Type: -

Identifier Source: org_study_id