A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer

Официальное название

A Randomized, Open, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) Positive Recurrent or Metastatic Breast Cancer

Обзор

This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or docetaxel combined with trastuzumab and pertuzumab, respectively.

Вмешательства

• Препарат TQB2102 for Injection
  TQB2102 is a next-generation HER2 Antibody-Drug Conjugate drug proposed for patients with HER2 positive Recurrent/Metastatic Breast Cancer.
• Препарат Docetaxel combined + Trastuzumab +Pertuzumab
  Positive control.

Первичные конечные точки

• Objective Response Rate [Срок оценки: Up to approximately 30 months]
• Progression-Free Survival [Срок оценки: Up to approximately 30 months]

Вторичные конечные точки (8)

• Overall Survival [Срок оценки: Up to approximately 30 months]
• Duration of Remission [Срок оценки: Up to approximately 30 months]
• The incidence of adverse events [Срок оценки: Up to approximately 52 months]
• The severity of adverse events [Срок оценки: Up to approximately 52 months]
• Blood concentrations of the Antibody-Drug Conjugate (ADC) drug TQB2102 [Срок оценки: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8and 15 minutes after the end of infusion for Cycle 2, Cycle 4, (21 days as a treatment cycle)]
• The incidence of drug-resistant antibodies (ADA) and neutralizing antibodies (NAb) [Срок оценки: within 60 minutes prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8, Cycle16,and before administration and 28 days (± 7 days), (21 days as a treatment cycle)]
• Total antibodies [Срок оценки: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8and 15 minutes after the end of infusion for Cycle 2, Cycle 4, (21 days as a treatment cycle)]
• The small molecule toxin TQ22723 [Срок оценки: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8and 15 minutes after the end of infusion for Cycle 2, Cycle 4, (21 days as a treatment cycle)]

Критерии участия

Критерии включения

• Subjects voluntarily enrolled in this study with good compliance
• Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1
• HER2 positive, recurrent or metastatic invasive breast cancer confirmed by histopathology or cell pathology
• Defined hormone receptor (HR) status
• Has not received systemic anti-tumor therapy during the recurrence/metastasis stage (acceptable ≤ first-line endocrine therapy)
• If receiving (new) adjuvant therapy, it is required that the time interval between the end of systemic therapy (excluding endocrine therapy) and the discovery of recurrence/metastasis be greater than 12 months
• Have at least one measurable lesion according to RECIST 1.1 criteria;
• Good major organ function

Критерии исключения

• It is known that there is spinal cord compression or active central nervous system metastasis;
• Subjects with only skin and/or brain lesions as target lesions
• Combined diseases and medical history

• Have had or currently have other malignant tumors within the past 5 years of randomization
• Unrelieved toxic reactions above Common Terminology Criteria (CTC) AE grade 1 caused by any previous treatment
• Received major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to randomization
• There are diseases that affect intravenous injection and venous blood collection
• There are congenital bleeding and coagulation disorders present
• An arterial/deep vein thrombosis event occurred within 6 months prior to the first administration
• Poor blood pressure control
• Suffering from significant cardiovascular disease
• There is an uncontrolled infection of ≥ CTC AE grade 2 within 14 days before the start of treatment
• History of interstitial lung disease/pneumonia (non infectious) requiring steroid medication intervention in the past
• Individuals with moderate to severe pulmonary dysfunction/disease within 3 months prior to the first administration
• Active viral hepatitis with poor control
• Active syphilis infected individuals in need of treatment
• Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation
• Immunosuppressants or systemic or absorbable local hormone therapy are required to achieve immunosuppression
• History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases
• Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification>1.0 g
• Patients with renal failure requiring hemodialysis or peritoneal dialysis
• Poor control of diabetes
• Individuals with epilepsy who require treatment
• Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders
• Tumor related symptoms and treatment

• There is a third interstitial fluid accumulation or cancerous lymphangitis that cannot be controlled by drainage or other methods
• History of cumulative dose exposure to anthracyclines in the past
• Received radiation therapy within 3 weeks prior to the start of study treatment and endocrine therapy within 2 weeks prior to the start of study treatment
• Traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks before the start of the study treatment
• Research treatment related

• Previously received antibody conjugate therapy consisting of topoisomerase I inhibitors,;
• Allergic to any research drug or any ingredient or excipient in the drug;
• Individuals who experience severe hypersensitivity reactions after using monoclonal antibodies;
• Participated in other clinical trials of anti-tumor therapy within 4 weeks before the start of the research treatment.
• According to the researcher's judgment, there are situations that seriously endanger the safety of the subjects or affect their ability to complete the study.

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 · 25 центров

• Anhui Provincial Cancer Hospital — Хэфэй
• Anhui Provincial Hospital — Хэфэй
• Beijing Tiantan Hospital,Capital Medical University — Пекин
• Gansu Provincial Cancer Hospital — Lanzhou
• Gansu Provincial Cancer Hospital — Lanzhou
• Shantou Central Hospital — Shantou
• Affiliated Cancer Hospital of Harbin Medical University — Харбин
• Huaihe Hospital of Henan University — Kaifeng
• … и ещё 17 центров

Идентификаторы

NCT: NCT07003074 · TQB2102-III-06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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