Combination therapy using Anlotinib for HR+ metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of anlotinib-based combination therapy in female patients with hormone receptor-positive metastatic breast cancer who have previously been treated with CDK4/6 inhibitors. The approach involves administering anlotinib alongside various chemotherapy agents and immunotherapies to assess its effectiveness after standard treatments have failed. The study aims to provide insights into alternative treatment options for patients who have limited choices due to disease progression.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Hunan Provincial Tumor Hospital
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Quchang Ouyang
• Email: tgzybc@163.com
• Phone: 15676789890

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.