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NEAREST SITE: 3 miles
Investigational Site Number :8400040
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04478266

An Experimental Anti-Estrogen Therapy and a CDK 4/6 Inhibitor for Advanced, ER+, HER2- Breast Cancer

A Randomized, Multicenter, Double-blind Phase 3 Study of SAR439859 Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease Scientific Title

Purpose
To compare the anti-cancer activity and safety of giving the experimental anti-estrogen therapy SAR439859 in combination with palbociclib (Ibrance®) to giving the standard anti-estrogen therapy letrozole (Femara®) in combination with palbociclib.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have not yet started treatment for advanced or metastatic disease.    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: Experimental: SAR439859 and Palbociclib</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SAR439859, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Placebo for letrozole (Femara®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®), by injection, monthly, ongoing (if you are a pre/perimenopausal woman or a man)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Letrozole and Palbociclib</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for SAR439859, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®), by injection, monthly, ongoing (if you are a pre/perimenopausal woman or a man)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SAR439859 is a type of experimental anti-estrogen therapy called a selective estrogen receptor degrader (SERD) which binds to and breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone-sensitive breast cancer.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. It is approved for treating metastatic hormone positive, HER2 negative breast cancer.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is commonly used in combination with either letrozole (Femara®) or fulvestrant (Faslodex®).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04478266' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/treatment-of-breast-cancer-by-stage/treatment-of-stage-iv-advanced-breast-cancer.html' target='_blank'>American Cancer Society: Treatment of Stage IV (Metastatic) Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/ibrance' target='_blank'>Breastcancer.org: Palbociclib (Ibrance®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/next-generation-endocrine-therapy-moves-forward-in-breast-cancer-trial' target='_blank'>OncLive: Next-Generation Endocrine Therapy Moves Forward in Breast Cancer Trial</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Selective_estrogen_receptor_degrader' target='_blank'>Wikipedia: SERD</a> </li></ul>
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