HER2CLIMB-02 Trial to Assess Tucatinib and T-DM1 in HER2+ Breast Cancer

Giuseppe Curigliano, MD, discussed next steps following the HER2CLIMB study in HER2-positive breast cancer.

Giuseppe Curigliano, MD, an associate professor of Medical Oncology at the University of Milano and the head of the Division of Early Drug Development at the European Institute of Oncology, discussed next steps following the HER2CLIMB study (NCT02614794) in HER2-positive breast cancer.

The HER2CLIMB study enrolled 612 patients with HER-positive breast cancer patients, and ultimately met its primary end point of progression-free survival. Investigators evaluated tucatinib (Tukysa) in combination with trastuzumab (Herceptin) and capecitabine (Xeloda) compared with placebo in patients with HER2-positive breast cancer.

Following the positive data from the HER2CLIMB study, the HER2CLIMB-02 trial (NCT03975647) was initiated where patients were allowed crossover from the placebo arm of the trial to the experimental group. In the trial, patients are being administered ado-trastuzumab emtansine (T-DM1) and tucatinib or T-DM1 and placebo.

Curigliano notes that the outcomes of this trial will influence whether or not there is a new standard of care for patients with HER2-positive breast cancer in the second-line setting.


0:08 | Some of the most important data here are, first, there was a survival benefit in the third-line setting. Up to now, HER2CLIMB is the only study to demonstrate an overall survival benefit in this setting. The second intriguing result is the progression-free survival benefiting the patients with brain metastases.

0:37 | I believe the most important next step in the context of metastatic breast cancer is the HER2CLIMB-02 study. That is a prospective randomized trial, comparing the tucatinib vs placebo in combination with T-DM1 for patients with advanced or metastatic HER2-positive breast cancer. This study has been designed to compare T-DM1 plus tucatinib vs T-DM1 plus placebo in patients progressing after dual blockade with pertuzumab [Perjeta]/trastuzumab.

1:19 | The primary end point of this study is progression-free survival. In the eligibility criteria, of course, we have also patients with metastatic HER2-positive breast cancer and also patients with brain metastases, including untreated brain metastases and previously treated brain metastases. If this study is positive, we will have a new standard of care in the second-line setting that will come behind T-DM1 plus tucatinib.

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