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1

NEAREST SITE: 1718 miles
Siteman Cancer Center at Saint Peters Hospital
Saint Peters,MO

VISITS: 2-3 visits the first month, then 1 to 3 visits a month thereafter

PHASE: I-II

NCT ID: NCT03939897

Fulvestrant & Abemaciclib With and Without Copanlisib in Metastatic Hormone Positive, HER2 Negative Breast Cancer

A Randomized Phase I/II Trial of Fulvestrant and Abemaciclib in Combination With Copanlisib (FAC) Versus Fulvestrant and Abemaciclib Alone (FA) for Endocrine-Resistant, Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer (FAC vs FA) Scientific Title

Purpose
To compare the effects (good and bad) of giving the CDK 4/6 inhibitor abemaciclib (Verzenio®) and the anti-hormone drug fulvestrant (Faslodex®) with or without the PI3K inhibitor copanlisib (Aliqopa®).
Who is this for?
People with metastatic (stage IV) hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer treated with no more than one chemotherapy for metastatic disease and your cancer must have progressed during or after hormone therapy.    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">Copanlisib (Aliqopa®), by IV, 2 or 3 times a month</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, twice the first month, then monthly thereafter</li> <li class="seamTextUnorderedListItem">If you are premenopausal, an ovarian suppression drug, by injection, monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, twice the first month, then monthly thereafter</li> <li class="seamTextUnorderedListItem">If you are premenopausal, an ovarian suppression drug, by injection, monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 biopsy</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Copanlisib (Aliqopa®) is a type of targeted therapy called a PI3K inhibitor. It is approved for use in lymphoma, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. It is approved for use in people with metastatic hormone positive (ER+ and/or PR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is approved to treat certain people with metastatic hormone positive (ER+ and/or PR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PI3K</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03939897' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/verzenio' target='_blank'>Breastcancer.org: Verzenio (Abemaciclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617044.html' target='_blank'>MedLine Plus: Copanlisib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hcp.aliqopa-us.com/mechanism-of-action/' target='_blank'>Bayer Information Page: Aliqopa® (Copanlisib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-breast-cancer-treatment/hormone-therapy/ovarian-suppression-breast-cancer' target='_blank'>Breast Cancer Now: Ovarian Suppression and Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hematologyandoncology.net/archives/september-2019/phosphoinositide-3-kinase-inhibition-in-the-treatment-of-hormone-receptor-positive-breast-cancer/' target='_blank'>Journal Article: Phosphoinositide 3-Kinase Inhibition in the Treatment of Hormone Receptor–Positive Breast Cancer</a> </li></ul>
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