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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT07396454
Phase
PHASE2
Status
Recruiting
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Conditions

  • HER2-Negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Radiotherapy Combined with Anlotinib and a Microtubule Inhibitor — DRUG
    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.

Study Details

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.

Key Dates

First listed
Feb 9, 2026
Start date
Feb 10, 2026
Status verified
Feb 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radiotherapy 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.

Primary Outcome Measure

Central nervous system progression-free survival (CNS-PFS) rate [ Time Frame: 12months ]

Central Contacts

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