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In response to COVID-19, some breast cancer trials have temporarily stopped enrolling new patients. Use the contact information in our trial listings to call or email the research site for information about a trial's status.

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(Last updated: May 21, 2020)

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1

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

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03774472

Hydroxychloroquin, Palbociclib & Letrozole for ER+ HER2- Breast Cancer

Phase I/II Safety and Efficacy Study of Autophagy Inhibition With Hydroxychloroquine to Augment the Antiproliferative and Biological Effects of Pre-Operative Palbociclib Plus Letrozole for Estrogen Receptor-Positive and HER2-Negative Breast Cancer Scientific Title

Purpose
To study the safety, best dose and effects (good and bad) of giving hydroxychloroquine along with palbociclib (Ibrance®) and letrozole (Femara®).
Who is this for?
Postmenopausal women with HR positive and HER2 negative breast cancer who has not yet had surgery (if you have stage I, II, or III breast cancer) and has not been treated with a CDK 4/6 inhibitor (if you have metastatic (stage IV) breast cancer).    Full eligibility criteria
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  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following treatment by mouth, daily for 1 year: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hydroxychloroquine</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®)</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Participants with early stage (stage I-III) breast cancer will undergo standard surgery after 1 or 5-6 months.</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hydroxychloroquine is a drug that decreases immune responses in the body. It is routinely used to prevent or to treat malaria and some auto-immune diseases. </li> <li class="seamTextUnorderedListItem">Ibrance is a targeted drug that is given along with hormone therapy to treat metastatic breast cancer in postmenopausal women. </li> <li class="seamTextUnorderedListItem">Femara is an aromatase inhibitor used to treat early-stage and metastatic breast cancer in postmenopausal women. It is approved for use along with Ibrance.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03774472' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.webmd.com/drugs/2/drug-5482/hydroxychloroquine-oral/details' target='_blank'>WebMD: Hydroxychloroquine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5718030/' target='_blank'>NCBI: Repurposing Drugs in Oncology (ReDO)-chloroquine and hydroxychloroquine as anti-cancer agents</a> </li></ul>
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