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NEAREST SITE: 1482 miles
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas,TX

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT03952325

Tesetaxel and Immunotherapy in Advanced HER2- Breast Cancer

A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC (CONTESSA TRIO) Scientific Title

Purpose
To compare the safety and effects (good and bad) of the experimental oral chemotherapy tesetaxel when it is given alone or with one of three immunotherapies.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) or people, 65 or older, with advanced or metastatic HER2 negative breast cancer. You must not have already received chemotherapy for advanced disease.    Full eligibility criteria
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  • <p class="seamTextPara"> <u>Cohort 1:</u> </p> <p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tesetaxel, by mouth, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nivolumab, by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tesetaxel, by mouth, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab, by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tesetaxel, by mouth, every 3 weeks</li> <li class="seamTextUnorderedListItem">Atezolizumab, by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <u>Cohort 2:</u> </p> <p class="seamTextPara"> <i class="seamTextEmphasis">For over 65 years old with HER2 negative breast cancer</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tesetaxel, by mouth, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">To take part in the first cohort, you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) and have not received prior chemotherapy for advanced disease. </li> <li class="seamTextUnorderedListItem">To be part of the second cohort, you must be age 65 or older, have advanced or metastatic HER2 negative breast cancer, and have not received prior chemotherapy for advanced disease. </li> <li class="seamTextUnorderedListItem">In the first cohort, this study is comparing the safety and effects (good and bad) of an experimental oral chemotherapy drug called tesetaxel when it is given with one of three immunotherapy drugs. </li> <li class="seamTextUnorderedListItem">In the second cohort, the study is investigating the safety and effects (good and bad) of tesetaxel when it is given alone. </li> <li class="seamTextUnorderedListItem">The three immunotherapy drugs being used in this study are nivolumab (Opdivo®), pembrolizumab (Keytruda®), and atezolizumab (Tecentriq®). </li> <li class="seamTextUnorderedListItem">Opdivo and Keytruda are PD-1 inhibitors. They get the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). Both are approved for certain types of cancers. Their use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Tecentriq is a PD-L1 inhibitor. It gets the immune system to go after cancer cells by blocking PD-L1. </li> <li class="seamTextUnorderedListItem">Tecentriq in combination with Abraxane is an FDA-approved treatment for metastatic triple negative breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03952325' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ascopost.com/issues/july-25-2018/oral-taxane-shows-strong-activity-and-good-tolerability-in-metastatic-breast-cancer/' target='_blank'>ASCO post: Oral Taxane Shows Strong Activity and Good Tolerability in MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/peer-exchange/unmet-needs-mbc/tesetaxel-an-oral-taxane-for-hr-positive-mbc' target='_blank'>OncLive: Tesetaxel: An Oral Taxane for HR-Positive mBC</a> </li></ul>
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