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1

Inavolisib With Fulvestrant for Advanced HR+, HER2- Breast Cancer with PIK3CA Mutations

A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of inavolisib (Itovebi®) PI3K inhibitor with fulvestrant (Faslodex®) hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+), HER2 negative (HER2-) breast cancer with a PIK3CA mutation whose disease progressed while taking anti-hormone therapy with a CDK 4/6 inhibitor. You must not have received more than 1 line of anti-hormone therapy with a CDK 4/6 inhibitors for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib (Itovebi®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">To find out how well inavolisib with fulvestrant works, and how safe inavolisib is at different doses. </li> <li class="seamTextUnorderedListItem">If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated which allows cancer cells to grow.</li> <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">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</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/NCT07368998' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healthline.com/health/metastatic-breast-cancer/pik3ca-mutation-and-breast-cancer#what-is-the-pik-3-ca-gene' target='_blank'>Healthline: PIK3CA Mutations in Breast Cancer: What Does It Mean?</a> </li></ul>
1

Inavolisib With Fulvestrant for Advanced HR+, HER2- Breast Cancer with PIK3CA Mutations

A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
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Nearest Location from 94107:
346 miles
Los Angeles Cancer Network
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT07368998

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Phase II

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