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RECRUITINGPhase 3INTERVENTIONAL

A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer

A Randomized, Open-label, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus TCbHP in Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a randomized, open, positive drug control, multi center phase III study. Through the evaluation of tpCR, bpCR, ORR, EFS, IDFS, OS , AEs and other indicators, it proves the effectiveness and safety of TQB2102 for injection versus TCbHP in the neoadjuvant treatment of HER2 positive breast cancer patients.

Who May Be Eligible (Plain English)

Who May Qualify: - Voluntarily participate in this study, sign the willing to sign a consent form form, and have good compliance; - Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; expected survival \>6 months; - diagnosed by tissue sample (biopsy-confirmed) HER2-positive invasive breast cancer; - Hormone receptor (HR) status confirmed; - Clinical stage at diagnosis: T2-4 with any N, M0, or any T with N1-3, M0; - Agree to undergo breast cancer resection if meeting surgical criteria after neoadjuvant therapy; - Major organ function is adequate, meeting specific criteria; - Must agree to use contraception during the study and for 6 months after study completion; female patients must have a negative serum pregnancy test within 7 days before enrollment and must not be lactating; male subjects must agree to use contraception during the study and for 6 months after study completion Who Should NOT Join This Trial: - Stage IV metastatic breast cancer or other cases judged by the investigator as unsuitable for radical surgical resection after neoadjuvant therapy; - Bilateral breast cancer or inflammatory breast cancer; - History of invasive breast cancer or ductal carcinoma in situ; - Prior anti-tumor therapy for breast cancer, including chemotherapy, endocrine therapy, targeted therapy, radiotherapy, surgery, etc.; - Comorbidities and medical history: - Other malignancies within 5 years or currently; - Adverse reactions from prior treatment not recovered to CTCAE v5.0 grade ≤1; - Major surgery, significant traumatic injury within 4 weeks before first dose, or anticipated major surgery during the study, or unhealed wounds/fractures; - Conditions affecting intravenous injection or blood sampling; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Voluntarily participate in this study, sign the informed consent form, and have good compliance; * Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; expected survival \>6 months; * Histologically or cytologically confirmed HER2-positive invasive breast cancer; * Hormone receptor (HR) status confirmed; * Clinical stage at diagnosis: T2-4 with any N, M0, or any T with N1-3, M0; * Agree to undergo breast cancer resection if meeting surgical criteria after neoadjuvant therapy; * Major organ function is adequate, meeting specific criteria; * Must agree to use contraception during the study and for 6 months after study completion; female patients must have a negative serum pregnancy test within 7 days before enrollment and must not be lactating; male subjects must agree to use contraception during the study and for 6 months after study completion Exclusion Criteria: * Stage IV metastatic breast cancer or other cases judged by the investigator as unsuitable for radical surgical resection after neoadjuvant therapy; * Bilateral breast cancer or inflammatory breast cancer; * History of invasive breast cancer or ductal carcinoma in situ; * Prior anti-tumor therapy for breast cancer, including chemotherapy, endocrine therapy, targeted therapy, radiotherapy, surgery, etc.; * Comorbidities and medical history: * Other malignancies within 5 years or currently; * Adverse reactions from prior treatment not recovered to CTCAE v5.0 grade ≤1; * Major surgery, significant traumatic injury within 4 weeks before first dose, or anticipated major surgery during the study, or unhealed wounds/fractures; * Conditions affecting intravenous injection or blood sampling; * Congenital bleeding or coagulation disorders, or bleeding/coagulation disorders within 28 days before study treatment, or use of aspirin \>325 mg/day (maximum antiplatelet dose), dipyridamole, ticlopidine, clopidogrel, or cilostazol within 7 days before study treatment; * Arterial/deep venous thrombotic events within 6 months before first dose, e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism; * Poorly controlled blood pressure (systolic ≥150 mmHg or diastolic ≥100 mmHg); * Significant cardiovascular disease, including; * Uncontrolled ≥CTCAE grade 2 infection within 14 days before study treatment; * History of interstitial lung disease/pneumonitis (non-infectious) requiring steroid treatment, current interstitial lung disease/pneumonitis, or suspected interstitial lung disease/pneumonitis on screening imaging that cannot be ruled out; * Tumor-related symptoms and treatment: * Prior excisional biopsy of primary tumor and/or axillary lymph nodes or sentinel lymph node biopsy before study treatment; * Surgery, chemotherapy, radiotherapy, or other anti-tumor therapy within 3 weeks before study treatment (washout period calculated from last treatment); * Prior taxane or carboplatin therapy for any malignancy; * Treatment with National Medical Products Administration-approved traditional Chinese medicine with clear anti-tumor indications within 2 weeks before study treatment. * Study treatment-related: * Severe hypersensitivity to monoclonal antibodies; * Uncontrolled active autoimmune disease within 2 weeks before study treatment; * Allergy to any study drug or its components/excipients; * Live vaccination within 28 days before study treatment, including measles, mumps, rubella, varicella, yellow fever, seasonal flu, Influenza A virus subtype (H1N1) flu, rabies, Bacille Calmette-Guerin vaccine (BCG), and typhoid vaccines. * Any condition judged by the investigator to jeopardize subject safety or study completion.

Treatments Being Tested

DRUG

TQB2102 for injection

TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)

DRUG

Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection

TCbHP is a commonly used chemotherapy scheme for HER2 positive breast cancer. H represents Trastuzumab injection, P represents Pertuzumab Injection, T represents Docetaxel injection and C represents Carboplatin injection.

Locations (20)

The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical University
Wuhu, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Cancer Hospital Affiliated to Chongqing University, Chongqing Cancer Hospital, Chongqing Cancer Research Institute, and Chongqing Cancer Center
Chongqing, Chongqing Municipality, China
The First Hospital Affiliated to Army Medical University
Chongqing, Chongqing Municipality, China
Quanzhou First Hospital
Quanzhou, Fujian, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
Zhongshan Hospital Xiamen university
Xiamen, Fujian, China
ZhangZhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Gansu Provincial Academic Institute for Medical Research, Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Meizhou People's Hospital
Meizhou, Guangdong, China
Shantou Central Hospital
Shantou, Guangdong, China