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1

NEAREST SITE: 341 miles
Beverly Hills Cancer Center
Beverly Hills,CA

VISITS: At least 1 visit every month, ongoing

PHASE: II-III

NCT ID: NCT04191499

Palbociclib, & Fulvestrant WIth or Without GDC-0077 in Advanced HR+, HER2- Breast Cancer with a PIK3CA Mutation

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GDC-0077 Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer Scientific Title

Purpose
To compare the safety, effects (good and bad), and effectiveness of using GDC-0077 along with palbociclib (Ibrance®) and fulvestrant (Faslodex®) to using Ibrance® and Faslodex®.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that the study investigator finds tests positive for a PIK3CA mutation; have been treated with hormone therapy in the non-metastatic setting; and have not started treatment for metastatic breast cancer.    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</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-0077, by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, (3 weeks on 1 week off)</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) by injection, once a month</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, (3 weeks on 1 week off)</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) by injection, once a month</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-0077 is an experimental targeted therapy that blocks the PI3K pathway.</li> <li class="seamTextUnorderedListItem">Ibrance® is a type of targeted therapy called a CDK4/6 inhibitor. It is used along with a hormone therapy to treat advanced HR positive, HER2 negative breast cancer. </li> <li class="seamTextUnorderedListItem">Faslodex is a hormone therapy used to treat advanced HR positive breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04191499' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/pi3k-inhibitor-gdc-0077' target='_blank'>NCI Drug Dictionary: GDC-0077</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies' target='_blank'>Breastcancer.org: Targeted Therapies for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/publications/cure/2019/breast-2019/a-brighter-outlook-for-metastatic-breast-cancer' target='_blank'>Cure Today: A Brighter Look for Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ibrance.com/about-ibrance?src_code=IBRW10028851#faq' target='_blank'>Pfizer Oncology: Ibrance® (Palbociclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/fda-expands-use-of-faslodex-for-bc' target='_blank'>Breastcancer.org: FDA Expands Use of Faslodex for Breast Cancer</a> </li></ul>
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