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(Last updated: December 03, 2021)

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NEAREST SITE: 1454 miles
Research Site
Fort Worth,TX

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04538742

Trastuzumab Deruxtecan Alone and with Other Therapies for Advanced HER2-Positive Breast Cancer

A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With HER2-positive Metastatic Breast Cancer (DESTINY-Breast07) Scientific Title

Purpose
To study the safety, side effects, and anti-cancer activity of giving the antibody-drug conjugate (ADC) trastuzumab deruxtecan (Enhertu®) alone and with other anti-cancer therapies.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2-positive (HER2+) breast cancer. You must have received already received at least one therapy for advanced disease.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be randomly assigned to 1 of 6 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) by IV, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) by IV, ongoing</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 6</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by IV, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver chemotherapy directly to cancer cells. It is approved to treat some metastatic HER2+ breast cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 inhibitor. It works by stimulating the body's immune system to go after cancer cells. It is approved to treat some cancers, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) is a HER2-targeted therapy commonly used to treat HER2-positive breast cancer.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy routinely used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a HER2-targeted therapy. Research indicates it 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></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04538742' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/enhertu' target='_blank'>Breastcancer.org: Enhertu® (Trastuzumab Deruxtecan)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/news/march-2021/updated-destiny-breast01-results-show-trastuzumab-deruxtecan-nxki-delivers-durable-responses/' target='_blank'>The ASCO Post: Miami Breast Cancer Conference, Updated DESTINY-Breast01 Results Show Trastuzumab Deruxtecan-nxki Delivers Durable Responses</a> </li></ul>
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