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1

NEAREST SITE: 2013 miles
University of Alabama at Birmingham
Birmingham,AL

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03368729

Niraparib and Herceptin in Women With Metastatic HER2+ Breast Cancer

A Phase 1b/2 Study of the PARP Inhibitor Niraparib in Combination With Trastuzumab in Patients With Metastatic HER2+ Breast Cancer Scientific Title

Purpose
To look at the safety, effects (good and bad), and anti-cancer activity of combining niraparib (Zejula®) with trastuzumab (Herceptin®).
Who is this for?
Women with metastatic (stage IV) HER2 positive (HER2+) breast cancer who have already been treated with a HER2 targeted therapy, have not been treated with a PARP inhibitor, and do not have a hereditary BRCA1/2 mutation.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zejula is at type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA. It is approved to treat women with certain types of reproductive cancers. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Herceptin is a HER2-targeted therapy approved to treat HER2 positive breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03368729' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zejula.com/en' target='_blank'>Drug Company Information Page: Zejula® (Niraparib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/herceptin?gclid=Cj0KCQiAyKrxBRDHARIsAKCzn8zEHqEyTfwjNEW138WZ4GeUdB3CVmQfk-GJ5zPldOhQ2p6lEMBu1fsaAt6rEALw_wcB' target='_blank'>Breastcancer.org: Herceptin</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-breast-cancer-treatment/parp-inhibitors-in-breast-cancer-treatment' target='_blank'>Breast Cancer Now: PARP Inhibitors in Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sciencedaily.com/releases/2012/09/120917084946.htm' target='_blank'>ScienceDaily: PARP Inhibitors May Have Clinical Utility in HER2-positive Breast Cancers</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/25128455' target='_blank'>PubMed Abstract: Poly (ADP-ribose) Polymerase Inhibition Enhances Trastuzumab Antitumour Activity in HER2 Overexpressing Breast Cancer.</a> </li></ul>
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