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(Last updated: November 13, 2019)

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NEAREST SITE: 2453 miles
Johns Hopkins University
Baltimore,MD

VISITS: 2 visits in the first month; visits every 3-4 months while on treatment

PHASE: II

NCT ID: NCT03439735

Predicting Response to Treatment with an AI and Palbociclib for HR+ Advanced Breast Cancer

Prospective Evaluation of Determinants of Resistance to First-line Therapy With an Aromatase Inhibitor and the Cyclin-dependent Kinases 4 and 6 Inhibitor Palbociclib in Hormone Receptor Positive Metastatic Breast Cancer Scientific Title

Purpose
To see if certain blood and tumor tests can help researchers predict which patients' tumors will respond to an aromatase inhibitor and Ibrance®.
Who is this for?
Women and men with newly diagnosed estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) advanced breast cancer who will be treated with an aromatase inhibitor and palbociclib (Ibrance®).    Full eligibility criteria
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  • <p class="seamTextPara"> You will undergo the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draws: at the start of treatment, 1 month later, and every 3-4 months while on treatment</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The researchers will analyze each patient's tumor tissue and blood samples during treatment. </li> <li class="seamTextUnorderedListItem">They will be looking specifically at a mutation, called ESR1, that can develop in cancer cells. </li> <li class="seamTextUnorderedListItem">Previous studies have suggested that cancer cells with this mutation may be less likely to respond to an aromatase inhibitor. </li> <li class="seamTextUnorderedListItem">The researchers will use what they learn to help doctors personalize treatment options for metastatic breast cancer patients.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03439735' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://jhoponline.com/breast-cancer/17182-esr1-mutations-occur-often-in-estrogen-receptor-positive-breast-cancer' target='_blank'>Journal article: ESR1 Mutations Occur Often in Estrogen Receptor–Positive Breast Cancer</a> </li></ul>
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