6.0 mg/kg of TQB2102 for injection: TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 6.0 mg/kg.
7.5 mg/kg of TQB2102 for injection: TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 7.5 mg/kg.
Study summary
To evaluate the efficacy and safety of neoadjuvant treatment with TQB2102 for injection in patients with Her2 positive breast cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Total physiological complete response (tpCR) — Up to 12 months. The percentage of the patients where the primary breast lesion shows no residual infiltrating cancer and the regional lymph nodes are negative.
Trial sites (7)
Facility
City
Region
Status
Chongqing Cancer Hospital
Chongqing
Chongqing Municipality
Fujian Cancer Hospital
Fuzhou
Fujian
Guizhou Cancer Hospital
Guiyang
Guizhou
Harbin medical university cancer hospital
Harbin
Heilongjiang
Hunan Cancer Hospital
Changsha
Hunan
Liaoning Cancer Hospital & Institute
Shenyang
Liaoning
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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