Anlotinib-based Combination Therapy in Patients with Hormone Receptor-positive（HR+） Metastatic Breast Cancer(MBC) .

Официальное название

A New Option for Post-CDK4/6is Resistance Era: Multicenter Real-world Study of Anlotinib-based Combination Therapy in Hormone Receptor-positive Metastatic Breast Cancer Resistant to CDK4/6is.

Обзор

Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors combined with hormonal therapy are the current standard frontline treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER-2)-negative metastatic breast cancer (MBC). However, the optimal treatment after progression on CDK4/6 inhibitors remains unknown. Anlotinib is an oral multi-target tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. This study aimed to evaluate the safety and efficacy of anlotinib-based combination therapy in patients with HR+ MBC previously treated with a CDK4/6 inhibitor.

Вмешательства

• Другое Anlotinib+eribulin/nab-paclitaxel/etoposide/capecitabine/pembrolizumab/ sintilimab/ fulvestrant, etc
  Anlotinib (8/10/12 mg daily, Day 1-14 of each cycle) was administered orally to fasting patients, with dose reductions to 10 mg or 8 mg in cases of intolerable toxicity. Combination agents included eribulin, nab-paclitaxel, etoposide, capecitabine, pembrolizumab, sintilimab, or fulvestrant, among others.

Первичные конечные точки

• Progression free survival (PFS) [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (4)

• Objective response rate (ORR) [Срок оценки: through study completion, an average of 1 year]
• Disease control rate (DCR) [Срок оценки: through study completion, an average of 1 year]
• Overall survival(OS) [Срок оценки: through study completion, an average of 5 year]
• Incidence of Treatment-Emergent Adverse Events (Safety) [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Female patients aged 18 to 75 years, with an ECOG score of 0-1, and an expected survival of at least 3 months;
• Presence of measurable lesions as defined by RECIST 1.1 criteria;
• Histopathologically confirmed HR-positive/HER2-negative breast cancer. HER2 negativity is determined by an immunohistochemistry (IHC) result of HER2 (0/1+). If the result is HER2 (++), a FISH or CISH test is required to confirm the absence of HER2 amplification;
• Patients who have undergone multiple lines of advanced therapy with no remaining standard treatment options;
• Prior treatment with at least one line of CDK4/6 inhibitors and endocrine therapy;
• Disease progression following aromatase inhibitor (AI) or fulvestrant combined with CDK4/6 inhibitors, either as adjuvant therapy or as systemic treatment for advanced disease.

Критерии исключения

• Patients with HER2-positive breast cancer confirmed by histology or cytology;
• Patients who discontinued therapy due to non-disease progression reasons, such as adverse events or other non-medical factors;
• Detection of a second primary malignant tumor at the time of enrollment;
• Failure to complete CDK4/6 inhibitor therapy;
• Pregnant or breastfeeding patients;
• Presence of third-space fluid accumulation (e.g., pleural effusion, ascites, pericardial effusion) that cannot be managed through drainage or other methods;
• Patients previously treated with anti-angiogenic agents, including small molecules such as anlotinib or apatinib, and large molecules such as bevacizumab;
• Patients currently receiving any other anti-tumor treatment for any other malignancies.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Китай · 1 центр

• Hunan Provincial Tumor Hospital — Чанша

Публикации

• Chen Y, Liu B, Chen Z, Huang P, Wu X, Zhang Y, Sun T, Dong F, Wu T, Zong H, Gan L, Shao B, Ouyang Q. Anlotinib-containing regimens in HR+ advanced breast cancer after prior CDK4/6 inhibitor progression. NPJ Breast Cancer. 2026 Jun 24. doi: 10.1038/s41523-026-00982-5. Online ahead of print. PMID 42342669

Идентификаторы

NCT: NCT06734533 · ALTER-BC-005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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