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(Last updated: October 21, 2020)

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NEAREST SITE: 2693 miles
Dana-Farber Cancer Institute
Boston,MA

VISITS: At least 1 visit per month, ongoing

PHASE: I

NCT ID: NCT03294694

Ribociclib and Immunotherapy to Treat Metastatic Breast Cancer

A Phase 1 Study of the CDK4/6 Inhibitor Ribociclib (LEE011) in Combination With the PD-1 Inhibitor PDR001 in Patients With Metastatic Hormone Receptor-positive Breast Cancer and Metastatic Ovarian Cancer Scientific Title

Purpose
To evaluate the safety and effects (good and bad) of using ribociclib (Kisqali®) along with an immunotherapy or an immunotherapy and a hormone therapy.
Who is this for?
People with metastatic (stage IV) breast cancer that is hormone receptor positive and HER2-negative.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be assigned to one of the following groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily for 3 weeks per month</li> <li class="seamTextUnorderedListItem">Spartalizumab (PDR001), by IV, once a month</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily for 3 weeks per month</li> <li class="seamTextUnorderedListItem">Spartalizumab (PDR001), by IV, once a month</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 doses the first month, then once monthly</li> </ul> <p class="seamTextPara"> Additional procedures: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 biopsies (before treatment and at 7 weeks)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Kisqali is a type of targeted therapy called a CDK 4/6 inhibitor. It is approved for use along with an anti-estrogen therapy to treat HR-positive HER2-negative metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">The aromatase inhibitor being used in this study is fulvestrant (Faslodex®). </li> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is spartalizumab (PDR001). It is a type of immunotherapy that targets PD-1. </li> <li class="seamTextUnorderedListItem">This study also is enrolling patients with metastatic ovarian cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03294694' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ribociclib' target='_blank'>NCI Dictionary: Ribociclib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/spartalizumab' target='_blank'>NCI Dictionary: Spartalizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/fulvestrant' target='_blank'>NCI Dictionary: Fulvestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2018/ribociclib-fda-expanded-approval-breast-cancer?cid=eb_govdel' target='_blank'>NCI News: Ribociclib Approval Expanded for Some Women with Advanced Breast Cancer</a> </li></ul>
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