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(Last updated: August 03, 2020)

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1

NEAREST SITE: 2133 miles
Piedmont Cancer Institute, PC
Atlanta,GA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04060862

Ipatasertib or Placebo Plus Palbociclib + Fulvestrant in Advanced HR+, HER2- Breast Cancer

A Phase Ib/III Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer Scientific Title

Purpose
To look at whether adding the experimental drug ipatasertib to the currently used treatment regimen of fulvestrant (Faslodex®) and palbociclib (Ibrance®) is more effective than Faslodex, Ibrance, and a placebo.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone positive, HER2 negative (HR+, HER2-) breast cancer that recurred (came back) or progressed while you were on an anti-estrogen therapy.    Full eligibility criteria
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  • How can I learn more?
  • <p class="seamTextPara"> <i class="seamTextEmphasis">You will be randomly assigned to 1 of 2 groups:</i> </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ipatasertib, by mouth, daily, 3 weeks on, 1 week off, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) , by mouth, daily, 3 weeks on, 1 week off, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) , by injection, 1 or 2 times a month, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily, 3 weeks on, 1 week off, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 1 or 2 times a month, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ipatasertib is a targeted therapy that blocks AKT, a protein that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Faslodex is an anti-estrogen therapy approved to treat advanced breast cancer in postmenopausal women. </li> <li class="seamTextUnorderedListItem">Ibrance is a type of targeted therapy called a CDK 4/6 inhibitor. It is approved to treat metastatic breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04060862' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ipatasertib' target='_blank'>NCI Drug Dictionary: Ipatasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ibrance.com/about-ibrance?src_code=IBRW10028851' target='_blank'>Pfizer Oncology: Ibrance®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal/erds/faslodex' target='_blank'>Breastcancer.org: Fulvestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ascopost.com/issues/may-10-2019/postprogression-treatment-of-estrogen-receptor-positive-breast-cancer/' target='_blank'>ASCO: Postprogression Treatment of ER+ Breast Cancer</a> </li></ul>
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