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(Last updated: October 24, 2020)

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NEAREST SITE: 1655 miles
University of Iowa Hospital and Clinics
Iowa City,IA

VISITS: Weekly visits, ongoing

PHASE: I-II

NCT ID: NCT03911973

Gedatolisib and Talazoparib in Advanced HER2 Negative, Inherited BRCA1/2+ or Triple Negative Breast Cancer

Phase 2 Trial With Safety Run-In of Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers Big Ten Cancer Research Consortium BTCRC-BRE18-337 Scientific Title

Purpose
To determine the safety, best dose, and effects (good and bad) of gedatolisib when it is used in combination with talazoparib (Talzenna®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer whose cancer is triple negative (ER-, PR-, HER2-) or who have an inherited BRCA1 or BRCA2 mutation and HER2 negative (HER2-) breast cancer.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by IV, once a week </li> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, once a day</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib is an experimental targeted therapy that works by blocking two proteins, called PI3K and mTOR, that help tumors grow. </li> <li class="seamTextUnorderedListItem">Talzenna is a type of targeted therapy called a PARP inhibitor. It is approved to treat HER2 negative advanced or metastatic breast cancer in people with an inherited BRCA mutation.</li> <li class="seamTextUnorderedListItem">Targets or mutations: inherited BRCA 1 and BRCA 2 mutations.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03911973' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/fda-approves-talazoparib-for-brcamutated-her2negative-breast-cancer' target='_blank'>OncLive: FDA Approves Talazoparib for BRCA-Mutated, HER2- Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizer.com/files/news/asco/Pfizer_IO_GetaPI3KFactSheet.pdf' target='_blank'>Pfizer Oncology Information Page: Gedatolisib</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>
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