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

Last updated: May 16, 2023
Sponsor: Wuhan Union Hospital, China
Overall Status: Active - Recruiting

Phase

4

Condition

Breast Cancer

Cancer

Treatment

Disitamab Vedotin combined with Tislelizumab

Clinical Study ID

NCT05861635
UHCT22575
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 nodenegative, 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+andISH negative;

Exclusion

Exclusion Criteria:

  1. Stage IV breast cancer;
  2. Have received anti-tumor treatment or radiotherapy for any malignant tumor in the pastfive years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma orsquamous cell carcinoma;
  3. At the same time, other clinical trials have received anti-tumor therapy. If theresearcher judges that the patient cannot benefit from the researcher, otheranti-tumor therapy can be ended.
  4. The patient has undergone major surgery unrelated to breast cancer within 4 weeksbefore enrollment, or has not fully recovered from such surgery;
  5. Previously received ADC drugs, immunosuppressants, anti-HER2 and other treatments.

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: Disitamab Vedotin combined with Tislelizumab
Phase: 4
Study Start date:
February 01, 2023
Estimated Completion Date:
February 01, 2026

Study 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

Connect with a study center

  • WuhanHU

    Wuhan, Hubei 430000
    China

    Active - Recruiting

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