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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 nodenegative, 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+andISH negative;
Exclusion
Exclusion Criteria:
- Stage IV breast cancer;
- 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;
- 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.
- The patient has undergone major surgery unrelated to breast cancer within 4 weeksbefore enrollment, or has not fully recovered from such surgery;
- 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
Connect with a study center
WuhanHU
Wuhan, Hubei 430000
ChinaActive - Recruiting

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