To hear about similar clinical trials, please enter your email below
Trial Title:
The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression
NCT ID:
NCT05861635
Condition:
Breast Cancer
Neoadjuvant Therapy
Conditions: Official terms:
Breast Neoplasms
Tislelizumab
Disitamab vedotin
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Disitamab Vedotin combined with Tislelizumab
Description:
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
Arm group label:
Disitamab Vedotin combined with Tislelizumab
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
WuhanHU
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Yao
Phone:
02785726375
Email:
jeaneyph@163.com
Start date:
February 1, 2023
Completion date:
February 1, 2026
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05861635
