Trial Title:
A Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer
NCT ID:
NCT06198751
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
6.0 mg/kg of TQB2102 for injection
Description:
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 6.0 mg/kg.
Arm group label:
6 mg/kg of TQB2102 for injection
Intervention type:
Drug
Intervention name:
7.5 mg/kg of TQB2102 for injection
Description:
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 7.5 mg/kg.
Arm group label:
7.5 mg/kg of TQB2102 for injection
Summary:
To evaluate the efficacy and safety of neoadjuvant treatment with TQB2102 for injection
in patients with Her2 positive breast cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Voluntarily participate in this study and sign informed consent;
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1; expected
survival of more than 3 months;
- Histologically confirmed invasive breast cancer, no history of any systemic
anti-tumor therapy for breast cancer;
- Confirmed as HER2 positive;
- Clinical stage at the time of visit is T0-4, N1-3, M0 or T2-4, N0, M0;
- Agree to undergo breast cancer surgery when reaching the surgical criteria after
neoadjuvant therapy;
- Major organ functions are good, meeting certain criteria;
- Agree to use contraception during the study and within 6 months after the study
ends; female patients must have a negative serum pregnancy test within 7 days before
enrollment and must be non-lactating.
Exclusion Criteria:
- IV stage metastatic breast cancer or deemed unable to achieve curative surgical
resection through neoadjuvant therapy by other investigators.
- Bilateral invasive breast cancer.
- Coexisting diseases and medical history:
1. History of invasive breast cancer.
2. Occurrence of any other malignant tumors within the last 3 years or current
simultaneous presence.
3. Underwent significant surgical treatment, incisional biopsy, or significant
trauma within 28 days before the start of the study.
4. Unhealed wounds or fractures.
5. Ocular diseases deemed clinically significant by the investigator.
6. Occurrence of arterial/deep venous thrombotic events within the last 6 months.
7. History of substance abuse with inability to quit or individuals with mental
disorders.
8. ≥ Grade 2 myocardial ischemia or infarction, arrhythmias, or ≥ Grade 2
congestive heart failure.
9. Uncontrolled ≥ CTCAE Grade 2 infection within 14 days before the start of the
study.
10. History of interstitial lung disease/pneumonia requiring intervention with
steroid treatment, or current presence, or suspected interstitial lung
disease/pneumonia during the screening period that cannot be ruled out by the
investigator; individuals with pulmonary diseases deemed unsuitable for
participation by the investigator.
- Tumor-related symptoms and treatment:
1. Received surgery, chemotherapy, radiotherapy, or other anti-tumor therapy
within 4 weeks before the start of the study.
2. Received traditional Chinese medicine treatment with indications for anti-tumor
effects within 2 weeks before the start of the study.
3. Radiological evidence of tumor invasion into major vessels or judged by the
investigator to be highly likely to invade major vessels during the subsequent
study period, leading to fatal hemorrhage.
- Study treatment-related:
1. Experienced severe hypersensitivity reactions after using monoclonal
antibodies.
2. Developed uncontrollable active autoimmune diseases within 2 weeks before the
start of the study.
3. Allergic to any component or excipient in any study drug.
- Participated in other clinical trials of anti-tumor drugs within 4 weeks before the
start of the study.
- Deemed inappropriate for inclusion based on the investigator's judgment.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chongqing Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaohua Zeng, Doctor
Phone:
18996340992
Email:
zxiaohuacqu@126.com
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Chuangui Song, Doctor
Phone:
13960709993
Email:
songcg1971@outlook.com
Facility:
Name:
Guizhou Cancer Hospital
Address:
City:
Guiyang
Zip:
550001
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhihong Wang
Phone:
13595159308
Email:
wzh1968626@sina.com
Facility:
Name:
Harbin medical university cancer hospital
Address:
City:
Harbin
Zip:
150040
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qingyuan Zhang, Doctor
Phone:
13313612989
Email:
nsk86298070@163.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaobo Hu, Doctor
Phone:
13787797003
Email:
8833961@qq.com
Facility:
Name:
Liaoning Cancer Hospital & Institute
Address:
City:
Shenyang
Zip:
110801
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiang Zhang, Doctor
Phone:
18900917799
Email:
zhangqiang8220@163.com
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhimin Shao, Doctor
Phone:
13524514617
Email:
szm@163.com
Start date:
February 5, 2024
Completion date:
February 2026
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06198751
