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(Last updated: October 24, 2020)

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NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04090567

PARP Inhibitor Olaparib with Cediranib or Ceralasertib for Women with Advanced, HER2-, Inherited BRCA+ Breast Cancer

Overcoming PARP Inhibitor Resistance in BRCA Germline Mutation Positive Advanced Breast Cancer Scientific Title

Purpose
To study the anti-cancer activity and safety of combining the PARP inhibitor olaparib (Lynparza®) with an experimental targeted therapy--either cediranib or ceralasertib.
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV), HER2 negative (HER2-), inherited BRCA positive (BRCA1/2+) breast cancer.    Full eligibility criteria
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  • <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> <li class="seamTextUnorderedListItem">Cediranib, by mouth, 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">Ceralasertib, by mouth, daily (one week on, three weeks off)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. It stops the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP) and is already approved for use in women with metastatic, HER2-negative, inherited BRCA1/2 positive breast cancer. </li> <li class="seamTextUnorderedListItem">Cediranib is a tyrosine kinase inhibitor, a type of targeted therapy, that is designed to block the VEGF (vascular endothelial growth factor receptor) protein. </li> <li class="seamTextUnorderedListItem">Tumors use VEGF to grow new blood vessels. </li> <li class="seamTextUnorderedListItem">Research suggests VEGF inhibitors may slow or stop cancer cell growth. Giving cediranib with olaparib may also make the olaparib more effective. </li> <li class="seamTextUnorderedListItem">Ceralasertib is a new type of targeted therapy called an ATR inhibitor. It disrupts a cancer cell's ability to repair its own DNA, which can cause the cancer cells to die.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04090567' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/lynparza' target='_blank'>Breastcancer.org: Lynparza</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Cediranib' target='_blank'>Wikipedia: Cediranib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/atr-kinase-inhibitor-azd6738' target='_blank'>NCI Drug Dictionary: Ceralasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nejm.org/doi/full/10.1056/nejmoa1706450' target='_blank'>Journal Article: Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/lynparza-brca-treatment/' target='_blank'>Metastatic Trial Talk: Treating BRCA1/2 Metastatic Breast Cancer</a> </li></ul>
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