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

NCT05861635 | Unknown Phase 4 DMC

• 1 other identifier: UHCT22575
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Pathological complete remission (pCR) rate

  16 weeks

Study Arms (1)

Disitamab Vedotin combined with Tislelizumab

EXPERIMENTAL

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

Interventions

Disitamab Vedotin combined with Tislelizumab 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

Disitamab Vedotin combined with Tislelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

WuhanHU

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jing Yao

  Xiehe Hospital

  STUDY DIRECTOR

Central Study Contacts

Jing Yao, doctor

CONTACT

02785726375; jeaneyph@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: May 17, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: May 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)