Study Protocol for a Multicenter Phase 1 Clinical Trial Evaluating Tucatinib, Trastuzumab, and Capecitabine Combined with Stereotactic Radiosurgery in Patients with Brain Metastases from HER-2 Positive Breast Cancer (TUTOR) - Summary - MDSpire

Study Protocol for a Multicenter Phase 1 Clinical Trial Evaluating Tucatinib, Trastuzumab, and Capecitabine Combined with Stereotactic Radiosurgery in Patients with Brain Metastases from HER-2 Positive Breast Cancer (TUTOR)

  • By

  • Zouina Sarfraz

  • Ahmad Ozair

  • Mainak Bardhan

  • Amy K. Starosciak

  • Dilanis C. Perche

  • Lydia C. Hodgson

  • Yazmin Odia

  • Minesh P. Mehta

  • Rupesh Kotecha

  • Michael W. McDermott

  • Arun Maharaj

  • Ana Cristina Sandoval Leon

  • Reshma Mahtani

  • Manmeet S. Ahluwalia

  • December 4, 2025

  • 0 min

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Objective:

To evaluate the safety and efficacy of tucatinib, trastuzumab, and capecitabine combined with stereotactic radiosurgery (SRS) in patients with brain metastases from HER-2 positive breast cancer.

Key Findings:
  • Up to 50% of HER-2 positive breast cancer patients develop brain metastases.
  • Tucatinib has shown CNS activity and improves outcomes when combined with trastuzumab and capecitabine.
  • The HER2CLIMB trial demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) with the tucatinib regimen.
Interpretation:

Combining tucatinib, trastuzumab, and capecitabine with SRS may enhance treatment efficacy for patients with brain metastases, addressing both local and systemic disease.

Limitations:
  • HER2CLIMB trial did not include patients treated with SRS, creating a knowledge gap.
  • Limited understanding of the safety and efficacy of combining tucatinib with local radiation therapy.
Conclusion:

The study aims to fill the gap in knowledge regarding the combination of systemic therapies with SRS, potentially improving outcomes for patients with HER-2 positive brain metastases.

Original Source(s)

Study Protocol for a Multicenter Phase 1 Clinical Trial Evaluating Tucatinib, Trastuzumab, and Capecitabine Combined with Stereotactic Radiosurgery in Patients with Brain Metastases from HER-2 Positive Breast Cancer (TUTOR)

  • by Zouina Sarfraz, Ahmad Ozair, Mainak Bardhan, Amy K. Starosciak, Dilanis C. Perche, Lydia C. Hodgson, Yazmin Odia, Minesh P. Mehta, Rupesh Kotecha, Michael W. McDermott, Arun Maharaj, Ana Cristina Sandoval Leon, Reshma Mahtani, Manmeet S. Ahluwalia

  • December 4, 2025

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