Идёт набор NCT07610720

Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer

Фаза II С лечением Advanced/Metastatic Breast Cancer HER2-Positive Metastatic Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Dalpiciclib, Trastuzumab (Herceptin), Pertuzumab, Pyrotinib.
Кому может быть актуально: Состояния в реестре: Advanced/Metastatic Breast Cancer, HER2-Positive Metastatic Breast Cancer. Базовые параметры: 18 лет — 75 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluating the Efficacy and Safety of Dalpiciclib Plus Anti-HER2 Therapy and Endocrine Therapy in Patients With Induction-Treated Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer

Обзор

Efficacy and Safety of Dalpiciclib Combined with Anti-HER2 Targeted Therapy and Endocrine Therapy as First-line Maintenance Treatment for Patients with Recurrent or Metastatic Hormone-Receptor-Positive, HER2-positive Breast Cancer.

Подробное описание

This is a multicenter, single-arm, open-label, phase II clinical trial evaluating the efficacy and safety of dalpiciclib (a novel oral CDK4/6 inhibitor) combined with anti-HER2 therapy and endocrine therapy as maintenance treatment in patients with hormone receptor-positive (HR+)/HER2-positive metastatic breast cancer who have completed induction systemic therapy without disease progression.

Triple-positive (HR+/HER2+) metastatic breast cancer represents a unique subtype requiring dual pathway inhibition. Current standard first-line induction therapy includes taxane-based chemotherapy combined with trastuzumab and pertuzumab (THP) or pyrotinib (THPy), followed by maintenance with anti-HER2 therapy plus endocrine therapy. However, approximately 50% of patients progress within 18 months during maintenance therapy.

This study explores the addition of dalpiciclib to standard anti-HER2 and endocrine maintenance therapy to prolong progression-free survival. Dalpiciclib, the first domestically developed CDK4/6 inhibitor in China, has demonstrated favorable efficacy and a manageable safety profile in HR+/HER2- advanced breast cancer, with a lower incidence of febrile neutropenia and no observed interstitial lung disease.

Вмешательства

Препарат Dalpiciclib
Oral CDK4/6 inhibitor (dose modification permitted for toxicity management)
Препарат Trastuzumab (Herceptin)
Subcutaneous, 600mg Q3W; IV: 8mg/kg (loading) → 6mg/kg Q3W
Препарат Pertuzumab
IV: 840mg (loading) → 420mg Q3W
Препарат Pyrotinib
240mg qd Week 1 → 320mg qd from Week 2 (max dose); loperamide prophylaxis for diarrhea
Препарат Endocrine Therapy 1
Letrozole 2.5mg, Anastrozole 1mg, Exemestane 25mg, or Fulvestrant 0.5g IM on Days 1, 28 (initial: Days 1, 15, 28)

Первичные конечные точки

Progression-Free Survival (PFS) [Срок оценки: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.]

Вторичные конечные точки (5)

Objective Response Rate (ORR) [Срок оценки: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.]
Overall Survival (OS) [Срок оценки: From randomization until the end of the study (approximately 36 months)]
Safety and Tolerability [Срок оценки: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.]
Disease-Specific Quality of Life Assessed by EORTC QLQ-BR45 [Срок оценки: From the date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.]
Quality of Life Assessed by EORTC QLQ-C30 [Срок оценки: From the date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.]

Критерии участия

Критерии включения

Females aged 18 to 75 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer.
Hormone receptor (HR)-positive and HER2-positive.
Patients with no evidence of disease progression (including CR, PR, or SD)after 4-8 cycles of first-line systemic anti-tumor therapy.
ECOG Performance Status: 0-1.