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

May 16, 2023 updated by: Wuhan Union Hospital, China

Union Hospital Affiliated to Huazhong University of Science and Technology

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • WuhanHU
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathological complete remission (pCR) rate
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Investigators

  • Study Director: Jing Yao, Xiehe Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Anticipated)

February 1, 2025

Study Completion (Anticipated)

February 1, 2026

Study Registration Dates

First Submitted

February 18, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHCT22575

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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