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SABCS 2022 | HER2CLIMB-05: tucatinib + trastuzumab and pertuzumab as maintenance therapy for HER2+ metastatic BC

Erika Hamilton, MD, Sarah Cannon Cancer Center, Nashville, TN, provides an overview of the ongoing Phase III HER2CLIMB-05 (NCT05132582) first-line maintenance trial for human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer. The current first-line SOC for human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer is trastuzumab plus pertuzumab and a taxane. However, most patients will progress during maintenance with trastuzumab plus pertuzumab. HER2CLIMB-05 is investigating whether adding tucatinib to first-line SOC as maintenance therapy will extend progression-free survival (PFS) while maintaining quality of life (QOL). Additionally, the trial will be exploring whether tucatinib can help prevent the development of brain metastases in this patient population. This interview took place at the San Antonio Breast Cancer Symposium (SABCS) 2022 in San Antonio, TX.

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Transcript (edited for clarity)

HER2CLIMB-05 was presented as a trials in progress poster at San Antonio Breast Cancer Symposium in 2022. We’re very excited to be enrolling in this trial and an answer some of the important questions it asks. The design of this trial is essentially a first-line maintenance trial. And what I mean by that is our current standard in the first-line setting for HER2 positive metastatic breast cancer is a taxane in combination with trastuzumab and pertuzumab...

HER2CLIMB-05 was presented as a trials in progress poster at San Antonio Breast Cancer Symposium in 2022. We’re very excited to be enrolling in this trial and an answer some of the important questions it asks. The design of this trial is essentially a first-line maintenance trial. And what I mean by that is our current standard in the first-line setting for HER2 positive metastatic breast cancer is a taxane in combination with trastuzumab and pertuzumab.

The taxane is typically continued 6, 8, 10 cycles for a fixed amount of time, and then the chemotherapy is dropped out. Patients continue on their trastuzumab and pertuzumab. And if they have ER positivity, they often add endocrine therapy at that point. Once the chemo is dropped out, this enters the maintenance period.

And so, what HER2CLIMB is looking at is at that time that patients are dropping out the chemotherapy would adding tucatinib to trastuzumab and pertuzumab improve outcomes? Specifically, we’re looking at improved progression-free survival, but one of the other endpoints that I’m particularly interested in is subsequent development of brain metastases. We’re really seeing that in up to 50% of our patients with HER2-positive metastatic disease, that they’re ending up with brain metastases at some point in their treatment course.

And so, certainly prevention is much better than just treatment once something happens. And so, we’re curious of whether using tucatinib earlier in treatment settings potentially could prevent some brain metastases since it has such good activity in the brain.

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