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(Last updated: September 10, 2021)

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1

NEAREST SITE: 341 miles
Cedars-Sinai Medical Center
Los Angeles,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT04512261

Immunotherapy and Anti-HER2 Targeted Therapies for Metastatic HER2+ Breast Cancer that has Spread to the Brain

TOPAZ: Single Arm, Open Label Phase 1b/2 Study of Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases Scientific Title

Purpose
To study the safety and anti-cancer activity of giving tucatinib (Tukysa®), pembrolizumab (Keytruda®), and trastuzumab together.
Who is this for?
People with metastatic (stage IV) HER2-positive (HER2+) breast cancer that has spread to the brain (brain metastases).    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, twice a day, ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is an anti-HER2 targeted therapy. Research indicates tucatinib works against HER2+ breast cancer cells that have spread to the brain. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor or PD-1 inhibitor. It gets the immune system to go after cancer cells by blocking the PD-1 protein. It is already approved to treat some metastatic cancers, but its use in this trial is experimental. </li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04512261' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/adding-tukysa-to-tx-reduces-brain-lesion-growth' target='_blank'>Breastcancer.org: Adding Tukysa to Standard Treatment Reduces Brain Lesion Growth Risk in HER2-Positive Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/patients-with-brain-metastases-from-her2climb-show-significant-intracranial-responses-from-tucatinib-combo' target='_blank'>OncLive: Tucatinib Combo Shows Significant Intracranial Responses in HER2+ Breast Cancer Brain Mets</a> </li></ul>
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