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(Last updated: October 21, 2020)

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1

NEAREST SITE: 2384 miles
Duke University
Durham,NC

VISITS: At least 1 visit every month, ongoing

PHASE: II

NCT ID: NCT03167619

Durvalumab & Olaparib in Advanced Triple Negative Breast Cancer Treated with Chemotherapy

Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA) Scientific Title

Purpose
To compare the effects (good and bad) of using the targeted therapy olaparib (Lynparza®) alone or with an immunotherapy drug.
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer, already treated with at least four cycles of a platinum-based chemotherapy, and who have had no more than two prior chemotherapies for metastatic disease.    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">Olaparib (Lynparza®), by mouth, twice daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfizi®), by IV, once every month</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lynparza is approved to treat HER2-negative metastatic breast cancer in patients who test positive for an inherited BRCA mutation. </li> <li class="seamTextUnorderedListItem">Lynparza is a PARP inhibitor, a drug that blocks the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. </li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. </li> <li class="seamTextUnorderedListItem">It has been approved to treat certain other types of cancers, and its use in breast cancer is considered experimental.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03167619' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.imfinzi.com/stage-3-nsclc/about/how-imfinzi-works.html?source=imz_c_c_45&umedium=cpc&uadpub=google&ucampaign=2018imfinzidtcnsclcbranded_general&ucreative=branded_alone_ex&uplace=durvalumab&outcome=dtc&cmpid=1' target='_blank'>AstraZeneca Information Page: Imfinzi</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/durvalumab-improves-survival-in-stage-iii-nsclc' target='_blank'>Oncolive: Durvalumab/Olaparib Combo Is Active in BRCA-Mutated Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>
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