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(Last updated: October 14, 2021)

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NEAREST SITE: 2517 miles
Abramson Cancer Center of the University of Pennsylvania
Philadelphia,PA

VISITS: 1 visit every 2 weeks, ongoing

PHASE: I

NCT ID: NCT03685331

PARP Inhibitor, CDK 4/6 Inhibitor & Fulvestrant for Postmenopausal Women with Advanced, HR+, HER2- Breast Cancer with an Inherited or Tumor BRCA1/2 Mutation

A Phase I/II Trial of Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer Scientific Title

Purpose
To study the safety, anti-cancer activity and other effects (good and bad) of giving together the PARP inhibitor olaparib (Lynparza®), the CDK 4/6 inhibitor palbociclib (Ibrance®) and the anti-estrogen therapy fulvestrant (Faslodex®).
Who is this for?
Postmenopausal women with advanced (some stage III) or metastatic (stage IV) hormone positive (ER+ and/or PR+), HER2 negative (HER2) breast cancer that is BRCA1/2 positive (tumor or inherited) and who have received up to two lines of chemotherapy for metastatic disease.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice a day, 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, every 2 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The PARP inhibitor being used in this study is olaparib (Lynparza®). It is approved to treat HER2-negative metastatic breast cancer in women with an inherited BRCA1/2 mutation, but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a CDK 4/6 inhibitor, which is a type of targeted therapy. It is commonly used with an anti-estrogen therapy for women with metastatic, hormone positive breast cancer. Its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">BRCA1/2 mutations can be inherited (also called germline) or in a tumor (also called somatic).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03685331' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://voice.ons.org/news-and-views/germline-and-somatic-mutations-what-is-the-difference' target='_blank'>ONS Voice: Germline and Somatic Mutations, What Is the Difference?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/risk/factors/genetics' target='_blank'>Breastcancer.org: Genetics</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/olaparib.aspx' target='_blank'>Chemocare.com: Olaparib</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Palbociclib' target='_blank'>Wikipedia: Palbociclib</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a607031.html' target='_blank'>MedLinePlus.gov: Fulvestrant</a> </li></ul>
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