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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Rate of total physiological complete response (tpCR) evaluated by Independent Review Committee (IRC) [Срок оценки: Up to 26 months after study start]

Вторичные конечные точки (8)

• Rate of total physiological complete response (tpCR) evaluated by the investigator [Срок оценки: Up to 24 months after study start]
• Breast pathological complete response (bpCR) evaluated by IRC and the investigator [Срок оценки: Up to 26 months after study start]
• Objective response rate (ORR) [Срок оценки: Up to 22 months after study start]
• There year Event-free survival (EFS) [Срок оценки: Up to 50 months after study start]
• There year Invasive Disease-free survival (IDFS) [Срок оценки: Up to 50 months after study start]
• Overall Survival (OS) [Срок оценки: Up to 50 months after study start]
• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and indicators of abnormal laboratory tests [Срок оценки: From the date of signing the informed consent to 40 days after the last dosing or radical mastectomy for breast cancer or a new anti-tumor treatment, whichever comes first.]
• Incidence of Anti-drug antibody (ADA) and neutralizing antibodies (NAb) [Срок оценки: Up to 22 months after study start]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 78 центров

• The First Affiliated Hospital of Bengbu Medical University — Bengbu
• Anhui Provincial Cancer Hospital — Хэфэй
• The First Affiliated Hospital of Wannan Medical University — Wuhu
• Peking Union Medical College Hospital — Пекин
• Beijing Cancer Hospital — Пекин
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• The Second Affiliated Hospital of Chongqing Medical University — Чунцин
• The Cancer Hospital Affiliated to Chongqing University, Chongqing Cancer Hospital, Chongqi — Чунцин
• … и ещё 70 центров

Идентификаторы

NCT: NCT07043725 · TQB2102-III-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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