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Targeted Therapy (Inavolisib) plus Ribociclib (Kisqali®) and Fulvestrant (Faslodex®) for HR Positive, HER2 Negative Advanced Breast Cancer Without a PIK3CA Mutation

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of adding inavolisib to standard treatment with ribociclib (Kisqali®) and fulvestrant (Faslodex®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor-positive (ER+ and/or PR+), HER2-negative (HER2-) breast cancer that came back or progressed during or within 12 months after prior hormone (endocrine) therapy. Must not have a PIK3CA mutation and has a specific genetic change called chromosome 8p loss. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will 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">Inavolisib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) by injection, twice first month then monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) by injection, twice first month then monthly</li> <li class="seamTextUnorderedListItem">Placebo for Inavolisib, by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib (Itovebi®) is a type of targeted therapy called a PI3K inhibitor. It can stop cancer cell growth of tumors with a PIK3CA mutation.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li> <li class="seamTextUnorderedListItem">This study is looking at whether adding inavolisib to standard treatment (ribociclib plus fulvestrant) helps control breast cancer better than standard treatment alone.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07405801' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.itovebi-hcp.com/about/what-itovebi-treats.html' target='_blank'>Genentech Drug Information Page: Inavolisib (P13K Alpha Inhibitor)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lbbc.org/about-breast-cancer/treatments/hormonal-therapy/serds/fulvestrant' target='_blank'>Living Beyond Breast Cancer: Fulvestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lbbc.org/about-breast-cancer/treatments/targeted-therapy/for-hormone-receptor-positive/ribociclib' target='_blank'>Living Beyond Breast Cancer: Ribociclib</a> </li></ul>
1

Targeted Therapy (Inavolisib) plus Ribociclib (Kisqali®) and Fulvestrant (Faslodex®) for HR Positive, HER2 Negative Advanced Breast Cancer Without a PIK3CA Mutation

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation
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Nearest Location from 94107:
28 miles
Stanford Cancer Institute
Palo Alto, CA

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Visits:
Up to 2 years

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ClinicalTrials.gov: NCT07405801

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Phase II

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