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) - Takeaways - 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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  • 1

    HER-2 positive breast cancer accounts for 15-20% of cases and has a high incidence of brain metastases, affecting up to 50% of patients during their disease course.

  • 2

    Tucatinib, a selective HER-2 inhibitor, shows CNS activity and improves outcomes when combined with trastuzumab and capecitabine for treating brain metastases.

  • 3

    A phase 1b study demonstrated a 42% CNS objective response rate for the tucatinib, trastuzumab, and capecitabine combination in patients with measurable brain metastases.

  • 4

    The HER2CLIMB trial showed significant improvements in progression-free survival and overall survival for patients receiving tucatinib compared to placebo.

  • 5

    Combining targeted therapies with stereotactic radiosurgery aims to enhance treatment efficacy by addressing both microscopic and macroscopic disease in the CNS.

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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