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Last updated: 2025-12-18

(Breast Cancer) Is Enhertu Effective for Brain Metastases?

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(Breast Cancer) Is Enhertu Effective for Brain Metastases?

(Breast Cancer) Is Enhertu Effective for Brain Metastases?

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On August 8, 2022, Dr. Rupert Bartsch and colleagues from the Medical University of Vienna published results in Nature Medicine from the TUXEDO-1 Phase 2 clinical trial evaluating the efficacy and safety of Enhertu (trastuzumab deruxtecan) in HER2-positive breast cancer patients with brain metastases.

The TUXEDO-1 Phase 2 trial administered Enhertu (5.4 mg/kg every 3 weeks) to patients with untreated or previously treated brain metastases from HER2-positive breast cancer (N=15). The primary endpoint was intracranial response rate.

Patient characteristics: 60% had brain metastases that progressed on prior treatment; 14 female and 1 male; median age 69 years (range: 30–76); ECOG PS 0 in 40%; 12 patients had hormone receptor-positive disease.

Results:

Primary endpoint intracranial response rate: 73.3% (N=11/15), comprising:

  • Complete response: 13.3% (N=2)
  • Partial response: 60% (N=9)
  • Stable disease: 20% (N=3)

Median progression-free survival (PFS): 14 months.

Conclusion: Based on the TUXEDO-1 trial results, Dr. Bartsch and colleagues concluded that Enhertu demonstrated a high intracranial response rate in HER2-positive breast cancer patients with brain metastases.

Source: https://www.nature.com/articles/s41591-022-01935-8

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