A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer

Официальное название

A Randomized, Open-Label, Phase III Trial to Compare HRS-8080 Versus Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer Who Have Received at Least 2 Years of Standard Adjuvant Endocrine Therapy

Обзор

The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with intermediate or high risk early breast cancer.

Вмешательства

• Препарат HRS-8080 Tablets
  HRS-8080 tablets.
• Препарат Letrozole tablets
  Letrozole tablets.
• Препарат Tamoxifen Citrate Tablets
  Tamoxifen Citrate tablets.
• Препарат Anastrozole Tablets
  Anastrozole tablets.
• Препарат Exemestane tablets
  Exemestane tablets.

Первичные конечные точки

• The time from the date of randomization to the first occurrence of any of the following events: ipsilateral local or contralateral invasive recurrence, distant recurrence, or death from any cause. [Срок оценки: At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.]

Вторичные конечные точки (3)

• Invasive Disease-Free Survival (IDFS). [Срок оценки: At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.]
• Distant Metastasis-Free Survival (DRFS). [Срок оценки: At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.]
• Overall Survival (OS). [Срок оценки: Survival follow-up every 3 months, up to 5 years.]

Критерии участия

Критерии включения

• Female patients aged ≥ 18 and ≤ 75 years. Premenopausal patients must meet the eligibility of LHRH agonist therapy during the study period.
• Histologically confirmed invasive breast cancer by postoperative pathology, having received at least 2 years, but no more than 5 years, of adjuvant endocrine therapy.
• No evidence of recurrent or metastatic disease after surgery.
• ECOG performance status of 0 or 1.
• Adequate organ and bone marrow function.
• Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and be willing to use acceptable non-hormonal contraception methods from the time of informed consent until 7 months after the last dose of the study drug.
• Any acute toxicities from previous anti-tumor therapy have resolved to Grade 0-1 (per CTCAE v5.0).
• The patient has provided written informed consent (ICF), and is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Критерии исключения

• Tumor clinical stage IV (metastatic) breast cancer.
• History and/or treatment of any malignancy other than breast cancer within 5 years prior to randomization.
• History of severe pulmonary disease, such as interstitial lung disease.
• Concurrent or potential use of any anti-tumor therapy not specified in the study protocol.
• Major surgical procedure within 4 weeks prior to randomization.
• HIV infection or known AIDS, active hepatitis B, hepatitis C, or co-infection with hepatitis B and C.
• Poor cardiac function.
• Severe infection within 4 weeks prior to randomization.
• History of drug allergy.
• History of organ transplantation.
• History of substance abuse.
• Women within 1 year postpartum or who are currently breastfeeding.
• Patients deemed by the investigator as unsuitable for participation in this 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 · 2 центра

• The First Affiliated Hospital of Nanjing Medical University — Нанкин
• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07349069 · HRS-8080-305

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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