SHR-A1811 Combine With Pyrotinib for Locally Advanced/Metastatic HER2 Positive Breast Cancer

Официальное название

Safety and Efficacy of SHR-A1811 Combine With Pyrotinib for the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer, a Phase II Study

Обзор

The goal of this clinical trial is to learn if SHR-A1811 combine with Pyrotinib is safe and tolerable for patients with HER2 positive breast cancer. It will also learn about the anti-tumor efficacy of this combination therapy. Participants will take SHR-A1811 and pyrotinib every three weeks, until disease progression or intolerable toxicity.

Вмешательства

• Препарат SHR-A1811 4.0mg/kg
  SHR-A1811 4.0mg/kg, IV, Day 1, Q3W
• Препарат Pyrotinib 240mg
  Pyrotinib 240mg, po, QD, from Day 8 to Day 21,Q3W
• Препарат SHR-A1811 4.8mg/kg
  SHR-A1811 4.8mg/kg, IV, D1, Q3W
• Препарат Pyrotinib 320mg
  Pyrotinib 320mg, po, QD, from Day 8 to Day 21, Q3W

Первичные конечные точки

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Срок оценки: From the date of signing ICF until the end of the safety follow-up period, defined as 40 days after the last administration of SHR-A1811 or Pyrotinib]
• ORR [Срок оценки: from initiation of the study treatment until disease progression (or treatment discontinuation), the observation period is up to 36 months.]

Вторичные конечные точки (3)

• PFS [Срок оценки: from the date of enrollment until the first documented radiological disease progression (PD) or death from any cause, the observation period is up to 36 months.]
• OS [Срок оценки: The time from the date of enrollment to the date of death due to any cause. The observation period is up to 60 months.]
• DoR [Срок оценки: from the date of first documented response to the date of disease progression or death of any cause, the observation period is up to 36 months.]

Критерии участия

Критерии включения

• Age: ≥18 years old and ≤70 years old;
• Pathologically confirmed HER2-positive locally advanced or metastatic breast cancer;
• Progression during or after prior HER2-targeted therapy and chemotherapy in the advanced/metastatic setting OR progression during/within 12 months after completion of trastuzumab and taxane-based chemotherapy in the neoadjuvant/adjuvant setting OR after 2 cycles of trastuzumab and taxane-based chemotherapy in the neoadjuvant setting with suboptimal response (assessed as non-response) for locally advanced disease;
• At least one measurable lesion per RECIST v1.1 criteria.
• ECOG performance status of 0 or 1.
• Adequate Organ Function
• Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose. Male subjects with partners of childbearing potential must be surgically sterile or agree to use effective contraception during the trial. Sperm donation is not permitted during the study period.
• Subjects must voluntarily enroll in this study, sign the informed consent form, demonstrate good compliance, and be willing to cooperate with follow-up.

Критерии исключения

• Prior Pyrotinib in Advanced/Metastatic Setting;
• Prior Tropoisomerase I Inhibitor ADC Therapy;
• Active CNS Metastases;
• Other Malignancy;
• Recent Major Surgery/Trauma;
• Interstitial Lung Disease (ILD)/Severe Pulmonary Conditions;
• Significant Cardiac Disease;
• Inability to swallow oral medication, chronic diarrhea, intestinal obstruction, or other factors significantly affecting drug ingestion or absorption;
• Known hypersensitivity to any component of the investigational drugs in this study protocol;
• Immunodeficiency/Organ Transplant;
• Uncontrolled Third-Space Fluid Accumulation;
• Pregnancy/Breastfeeding/Contraception;
• Severe concomitant illness or comorbid conditions that may interfere with planned treatment or preclude study participation, as assessed by the investigator. This includes, but is not limited to, active hepatitis B or pulmonary infection requiring treatment.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07132242 · MA-BC-II-092

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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