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

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.

Trial Details

NCT ID
NCT07396454
Phase
PHASE2
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Radiotherapy Combined with Anlotinib and a Microtubule Inhibitor
Locations (sample)
  • Nanjing, China|32.06167,118.77778

Key Eligibility Criteria

  • Female patients aged 18 to 70 years (calculated on the date of informed consent signing).
  • Karnofsky Performance Status (KPS) score ≥ 70, or KPS = 60 primarily attributable to neurological symptoms.
  • HER2-negative status confirmed by pathology from Jiangsu Provincial Hospital's Pathology Department. HER2 immunohistochemistry (IHC) must be (-) or…
  • Presence of brain metastases confirmed by contrast-enhanced cranial MRI prior to enrollment. At least one measurable intracranial lesion is require…

For full eligibility, visit ClinicalTrials.gov.

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