RecruitingPhase 2NCT07396454

Study on the Treatment of HER2-negative Breast Cancer Brain Metastases With Radiotherapy Combined With Anlotinib

A Prospective, Single-Arm, Phase II Clinical Study of Radiotherapy Combined With Anlotinib and a Tubulin Inhibitor for the Treatment of HER2-Negative Breast Cancer With Brain Metastases

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

39 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

HER2-negative Breast Cancer

Summary

Angiogenesis inhibition represents a significant therapeutic target in breast cancer; however, despite its theoretical feasibility, progress in advanced breast cancer has been slow. Currently, there is a lack of prospective data supporting the selection of tyrosine kinase inhibitors (TKIs) in combination with local therapy. This phase II study aims to evaluate the efficacy and safety of stereotactic radiotherapy (SRT) or whole-brain radiotherapy (WBRT) combined with anlotinib in patients with HER2-negative advanced breast cancer and brain metastases.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of radiation therapy and a targeted drug called anlotinib for women with breast cancer that has spread to the brain (brain metastases), specifically in tumors that are HER2-negative. Researchers want to see whether this combination is safe and effective. **You may be eligible if...** - You are a woman between 18 and 70 years old - Your breast cancer has been confirmed as HER2-negative by pathology - Your cancer has spread to the brain - You have a good performance status (able to carry out normal daily activities with minimal assistance) **You may NOT be eligible if...** - You have already received anlotinib or similar drugs - You have severe heart, liver, or kidney problems - You are pregnant or breastfeeding - You have uncontrolled active infections - Your cancer has spread in a way that makes radiation or systemic treatment not feasible Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRadiotherapy Combined with Anlotinib and a Microtubule Inhibitor

Based on the size, location and number of brain metastases, an appropriate radiotherapy plan is given. Arloxitin can be used starting from the 1st day after radiotherapy to within 1 week. Arloxitin 12 mg, qd (it is recommended to take it before meals and take the medicine at the same time every day), take orally continuously for 2 weeks and then stop for 1 week. A 21-day period constitutes one treatment cycle. During the medication period, if there is a missed dose, if the time from the missed dose to the next dose is less than 12 hours, no additional dose will be given.

Locations(1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

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NCT07396454

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