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(Last updated: November 13, 2019)

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VISITS: 3 visits a month for at least 6 months


NCT ID: NCT03997123

Capivasertib & Paclitaxel as First Line Treatment for Advanced Triple Negative Tumors

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC. (CapItello290) Scientific Title

To compare the effects (good and bad) and effectiveness of paclitaxel (Taxol®) and capivasertib to paclitaxel (Taxol®) and a placebo.
Who is this for?
Women and men who are receiving their first treatment for advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) 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">Capivasertib, by mouth, 4 times a week, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, once a week, 3 weeks on, 1 week off, for at least 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, 4 times a week, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, once a week, 3 weeks on, 1 week off, for at least 6 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug that is used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Capivasertib is a targeted therapy drug that blocks Akt.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03997123' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/akt-inhibitor-azd5363' target='_blank'>NCI Drug Dictionary: Capivasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/conference-coverage/asco-2019/capivasertib-combined-with-fulvestrant-improves-pfs-in-er-breast-cancer' target='_blank'>Oncolive: Capivasertib Combined With Fulvestrant Improves PFS in ER+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medpagetoday.com/meetingcoverage/asco/80249' target='_blank'>Medpage Today: AKT Inhibitor Doubles PFS in Advanced Breast Cancer</a> </li></ul>
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