Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer

Официальное название

Efficacy and Safety of Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer：A Prospective, Single-Arm, Observational, Real-World Study

Обзор

This is a Prospective, Single-Arm, Observational, Real-World Study. The purpose of this study is to evaluate the safety and efficacy of pyrotinib combined with trastuzumab and pertuzumab for maintenance therapy in HER2-positive advanced breast cancer in the real-world setting.

Подробное описание

The current standard of care for first-line treatment of HER2+ advanced breast cancer consists of induction chemotherapy with a taxane (T) in combination with dual anti-HER2 monoclonal antibody, trastuzumab (H) and pertuzumab (P), followed by maintenance therapy with HP. However, most patients eventually experience disease progression on this regimen and not all will be able to receive a second-line treatment. The aim of this study was to evaluate the efficacy and safety of pyrotinib combined with HP as maintenance therapy for HER2-positive advanced breast cancer patients. The results are expected to provide real-world evidence for optimizing first-line maintenance treatment strategies in patients with HER2+ advanced breast cancer who had completed induction therapy with THP.

Вмешательства

• Препарат Pyrotinib
  240\~320mg given by mouth (orally) once daily every 21days
• Препарат Trastuzuma
  6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
• Препарат Pertuzumab
  420mg given by IV every 21 days
• Препарат Combination product: Trastuzumab + Pertuzumab
  600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days. May be given in place of trastuzumab and pertuzumab individually.

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: Up to approximately 3 years]

Вторичные конечные точки (6)

• Overall survival (OS) [Срок оценки: Up to approximately 5 years]
• Central nervous system (CNS) PFS [Срок оценки: Up to approximately 3 years]
• Incidence of adverse events [Срок оценки: Start of treatment until 3-year follow-up]
• Severity of adverse events [Срок оценки: Start of treatment until 3-year follow-up]
• Incidence of serious adverse events [Срок оценки: Start of treatment until 3-year follow-up]
• Severity of serious adverse events [Срок оценки: Start of treatment until 3-year follow-up]

Критерии участия

Критерии включения

• Age ≥ 18 years, male or female.
• Histologically or cytologically confirmed HER2-positive advanced breast cancer (IHC 3+, or IHC 2+ with ISH amplification), with known HR status.
• Have unresectable locally advanced or metastatic disease. If recurrent (after \[neo\]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab and pertuzumab received in the early breast cancer setting for advanced HER2+ disease.
• Have received 4-8 cycles of pre-study induction therapy including only trastuzumab, pertuzumab, and taxane as first-line of therapy for the treatment of advanced breast cancer prior to study enrollment. Participants are eligible provided they are without evidence of disease progression following completion of induction therapy.
• CNS Inclusion - Based on screening contrast-enhanced brain magnetic resonance imaging (MRI), participants may have any of the following: No evidence of brain metastases. Untreated brain metastases which are asymptomatic not needing immediate local treatment and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• Have planned to receive maintenance anti-tumor therapy with pyrotinib in combination with HP
• Negative serum pregnancy test; women of childbearing potential must use a highly effective contraceptive method from study initiation until at least 6 months after the last dose of study medication.
• Voluntary participation with written informed consent obtained prior to any study-related procedures.

Критерии исключения

• Other malignancy diagnosed within 5 years prior to enrollment.
• Prior treatment with any tyrosine kinase inhibitor targeting HER2 and/or epidermal growth factor receptor (EGFR) including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib.
• Patients who are difficult or unable to be followed-up.
• Other reasons that, in the investigator's judgment, make the patient 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

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07470203 · Pyro-HP Maintain

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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