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1

Inavolisib Targeted Therapy with CDK4/6 Inhibitor and Hormone Therapy for HR+, HER2- Advanced Breast Cancer with PIK3CA Mutations

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of inavolisib (Itovebi®) PI3K inhibitor with palbociclib (Ibrance®) CDK4/6 inhibitor and letrozole (Femara®) aromatase inhibitor.

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 with a PIK3CA mutation. You must have been diagnosed with de novo advanced/metastatic breast cancer or received at least 2 years of hormone therapy and completed hormone therapy at least 1 year before your advanced/metastatic diagnosis. You must have not yet received treatment for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib (Itovebi®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for inavolisib (Itovebi®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), 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">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</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/NCT06790693' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.itovebi.com/?c=ina-192c045e973&gad_source=1&gad_campaignid=22379686314&gclid=CjwKCAjw3_PCBhA2EiwAkH_j4vPWHwf18zpyVOBvHcRP6iHfngpGw_isqNXvAvPlr2i6vJ0TAA8mdxoCtHYQAvD_BwE&gclsrc=aw.ds' target='_blank'>Hoffman-La Roche: Inavolisib (Itovebi®)</a> </li></ul>
1

Inavolisib Targeted Therapy with CDK4/6 Inhibitor and Hormone Therapy for HR+, HER2- Advanced Breast Cancer with PIK3CA Mutations

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123)
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Nearest Location from 94107:
14 miles
Palo Alto Medical Foundation Research Center
San Mateo, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06790693

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Phase III

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