Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer

Официальное название

Randomized Trial of Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With Estrogen Receptor-Positive HER2 Negative Breast Cancer

Обзор

This study proposes to prove that the efficacy of adjuvant endocrine therapy for the premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy assessed by ultrasound response rate.

Вмешательства

• Препарат Goserelin+TAM+AI
  Goserelin 3.6mg subcutaneous injection per 4 weeks, for 16-20weeks. TAM 10mg oral twice a day for the first four weeks(to wait the Goserelin start to work in body) than change to AI 1mg oral once a day with Goserelin for the next 12-16 weeks.
• Препарат Epirubicin+CTX+5-Fu
  Epirubicin(80-100 mg/m2 Q21 days) + CTX(600 mg/m2 Q 21days) + 5-Fu (600 mg/m2 Q21 days or 200 mg/m2 •day from Day1 to day 21) for four to six cycles.

Первичные конечные точки

• ultrasound response rate [Срок оценки: within 2 weeks before surgery]

Вторичные конечные точки (1)

• pathological response rate(Miller & Payne standard) [Срок оценки: with 2 weeks after surgery]

Критерии участия

Критерии включения

• 35 years old <age≤55 years old, in premenopausal status(with the judgement by researchers when the patients are recruited) Histologically confirmed primary invasive breast cancer
• Stage: T2N0M0(cT>2cm, SLNB negative), hard to proceed the breast conserving surgery(not feasible or may affect the appearance of breast)
• Histologically confirmed HR+ (ER or PR positive, and >50% cell in IHC) HER2 negative breast cancer by pathological evaluation
• No other previous treatment for primary breast cancer
• Without other tumor or unstable complication or uncontrolled infection
• No contradiction for the third generation AIs, LHRHa, chemotherapy
• Attend the study voluntarily, sign the informed consent.

Критерии исключения

• Metastasis disease by pathological or radiological diagnosis
• the history of other tumor
• contradiction for the third generation AIs, LHRHa, chemotherapy
• Contradiction for adjuvant chemotherapy: serious cardiology or cerebral vessel disease, liver or kidney disfunction, blood system disease, the other situation or complication that are not suitable or cannot adaptable for chemotherapy
• Contradiction for proceeding surgery: contradiction for anesthesia, large lesion,T4, lymph node positive
• other situation not suitable for the research: psychological disease, mental disorder, social problem, geographic problem
• have been attendance in other anti-tumor treatment or other clinical trials 8) reject to attend 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 · 1 центр

• Beijing Cancer Hospital Breast Center — Пекин

Публикации

• Gu C, He Y, Zhang N, Liu Y, Li J, Wang T, Fan T, Fan Z, Ouyang T. A Non-Inferior Randomized Trial of Neoadjuvant Endocrine Therapy Compared to Neoadjuvant Chemotherapy in Premenopausal Patients With Hormone-Responsive and HER2-Negative Lymph Node-Negative Breast Cancer. Cancer Control. 2025 Jan-Dec;32:10732748251339958. doi: 10.1177/10732748251339958. Epub 2025 May 7. PMID 40331570

Идентификаторы

NCT: NCT02535221 · BCP12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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