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(Last updated: October 21, 2020)

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NEAREST SITE: 28 miles
Stanford University, School of Medicine
Palo Alto,CA

VISITS: 1 visit every 3 weeks for 1.5 years

PHASE: I

NCT ID: NCT03364348

PF-05082566 With Kadcyla® or Trastuzumab For Advanced HER2 Positive Breast Cancer

A Phase 1B Dose Escalation Trial of Human Anti-4-1BB Agonistic Antibody PF-05082566 in Combination With Adotrastuzumab-Emtansine or Trastuzumab in Patients With HER2-Positive Advanced Breast Cancer Scientific Title

Purpose
To look at the safety and effects (good and bad) of using utomilumab (PF-05082566) with trastuzumab emtansine (Kadcyla®) or trastuzumab (Herceptin).
Who is this for?
People with HER2 positive advanced (some stage III) or metastatic (stage IV) breast cancer.    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Emtansine (Kadcyla®), by IV, every 3 weeks </li> <li class="seamTextUnorderedListItem">Utomilumab (PF-05082566), by IV, every 3 weeks </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks </li> <li class="seamTextUnorderedListItem">Utomilumab (PF-05082566), by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Utomilumab is an investigational immunotherapy that targets 4-1BB (CD-137), a molecule that stimulates the immune system. </li> <li class="seamTextUnorderedListItem">Herceptin is a HER2-targeted therapy approved to treat HER2 positive breast cancer. </li> <li class="seamTextUnorderedListItem">Kadcyla is an antibody-drug conjugate (ADC). It uses Herceptin to deliver the chemotherapy drug DM1 directly to the cancer cells. It is approved to treat HER2 positive metastatic breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03364348' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/utomilumab/' target='_blank'>Immuno-oncology News: Utomilumab</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.hematologyandoncology.net/archives/april-2017/antibody-drug-conjugates-in-breast-cancer/' target='_blank'>Clinical Advances in Hematology & Oncology: ADC in Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.roche.com/media/releases/med-cor-2013-02-22.htm' target='_blank'>Roche: Kadcyla® Approval</a> </li></ul>
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