Study of Antivascular Therapy Combined With Chemotherapy Versus Chemotherapy in Adjuvant Therapy of TNBC-BLIS Patients (BCTOP-T-A03)

Официальное название

A Randomized, Open-label Phase III Clinical Trial Comparing Antivascular Therapy Combined With Standard Chemotherapy and Standard Chemotherapy in Adjuvant Therapy for Patients With Triple-Negative Breast Cancer, Basal-like Immunosuppressed Subtype (BCTOP-T-A03)

Обзор

This is a randomized, open-label phase III clinical trial comparing antivascular therapy combined with standard chemotherapy and standard chemotherapy in adjuvant therapy for patients with triple-negative breast cancer, basal-like/Immune suppressed subtype.

Вмешательства

• Препарат Antivascular therapy
  BP102 (anti VEGFR)
• Препарат Chemotherapy
  ddEC-P

Первичные конечные точки

• iDFS [Срок оценки: 5 years]

Вторичные конечные точки (3)

• DRFS [Срок оценки: 5 years]
• OS [Срок оценки: 5 years]
• AE [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Women aged 18-70 years old;
• Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1;
• Histological results recorded as TNBC (negative HER2, ER, and PgR status) and BLIS subtype according to the classification of FUSCC;
• Have stage IIA-IIIIC triple-negative breast cancer with non-metastatic surgically treated: pT1-3N1-3M0;
• Adequate hematological and end-organ function as defined by the following laboratory test results, which need to be completed within 28 days prior to the first study treatment: absolute neutrophil count (ANC) ≥ 1500 cells/μL (no G-CSF support therapy within 2 weeks prior to day 1 of course 1); Platelet count ≥ 75×109/L (no platelet transfusion within 2 weeks before day 1 of course 1); hemoglobin ≥ 9.0 g/dL (no RBC transfusion within 2 weeks before day 1 of course 1); AST, ALT, and alkaline phosphatase ≤ 3 × upper limit of normal (ULN) serum total bilirubin ≤ 1.0 × ULN; serum creatinine ≤ 1ULN and with an endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula);
• The surgical incision had fully healed prior to the commencement of the study;
• Female participants of reproductive potential are required to use a medically accepted form of contraception during the course of the study treatment and for at least three months following the last administration of the investigational drug;
• Sign the Informed Consent Form (ICF). The patient is judged by the investigator to have the ability to comply with the provisions of the protocol.

Критерии исключения

• Has received neoadjuvant therapy (including chemotherapy, targeted therapy, and radiotherapy)
• Has bilateral breast cancer;
• Has a previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
• Has metastatic (Stage 4) breast cancer;
• Has any >T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer);
• Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) < 50% (a cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous to randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
• Is pregnant, breastfeeding women, or women of childbearing age who cannot practice effective contraceptives;
• Patients participating in other clinical trials at the same time;
• Has known allergy to taxane and excipients.
• Has severe or uncontrolled infection;
• Has a history of psychotropic substance abuse and was unable to abandon drug habits or those with a history of mental disorders;
• the researchers judged patients to be unsuitable for 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 · 15 центров

• Beijing Cancer Hospital — Пекин
• Chongqing Cancer Hospital — Чунцин
• Fujian Medical University Union Hospital — Фучжоу
• Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital — Гуанчжоу
• Sun Yat-sen University Cancer Center — Guangdong
• Affiliated Hospital of Nantong University — Nantong
• Northern Jiangsu People's Hospital — Yangzhou
• The First Hospital of China Medical University — Шэньян
• … и ещё 7 центров

Идентификаторы

NCT: NCT05909332 · BCTOP-T-A03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗