Combination therapy using Anlotinib for HR+ metastatic breast cancer

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.

This study is testing a new combination treatment with anlotinib for women with hormone receptor-positive metastatic breast cancer who haven’t had success with other therapies.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Hunan Cancer Hospital (other)
• Drugs / interventions: bevacizumab, anlotinib, apatinib
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06734533 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 to 75 with HR-positive, HER2-negative metastatic breast cancer who have progressed after treatment with CDK4/6 inhibitors.

Not a fit: Patients with HER2-positive breast cancer or those who have not progressed after standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could offer a new treatment option for patients with HR+ metastatic breast cancer who have exhausted standard therapies.

How similar studies have performed: While the combination of anlotinib with other therapies is being explored, this specific approach in HR+ metastatic breast cancer is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Changsha, Hunan

• Hunan Provincial Tumor Hospital — Changsha, Hunan, China (RECRUITING)

Study contacts

• Study coordinator: Quchang Ouyang

Conditions: HR+ Breast Cancer