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1

Preventing Rash and Diarrhea From Capivasertib for Advanced Hormone Receptor Positive, HER2 Negative Breast Cancer With a PIK3CA, AKT1, or PTEN Mutation

A Phase II Trial to Improve Safety of Capivasertib for HR+/HER2- Metastatic Breast Cancer

Purpose: To find out whether starting preventive medicines at the same time as capivasertib can lower the rash and diarrhea that often happen with this treatment.

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 whose tumor has a PIK3CA, AKT1, or PTEN mutation. Your cancer must have come back or progressed, and you must be eligible to begin treatment with capivasertib (Truqap)® and fulvestrant (Faslodex)®. You must not have already taken an AKT inhibitor or a PI3K inhibitor. You must be receiving care at Yale University (New Haven, Connecticut). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capivasertib (Truqap®), by mouth, twice a day, 4 days on and 3 days off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for the first 3 doses, then every 4 weeks</li> <li class="seamTextUnorderedListItem">Cetirizine (Zyrtec), by mouth, once a day</li> <li class="seamTextUnorderedListItem">Loperamide (Imodium®), by mouth, once a day </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <p class="seamTextPara"> Capivasertib (Truqap®), by mouth, twice a day, 4 days on and 3 days off Fulvestrant (Faslodex®), by injection, every 2 weeks for the first 3 doses, then every 4 weeks Cetirizine (Zyrtec®), by mouth, once a day</p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capivasertib works well for many people with hormone receptor positive, HER2 negative breast cancer, but it commonly causes rash and diarrhea, which can be bad enough that people reduce their dose or stop the medicine. </li> <li class="seamTextUnorderedListItem">This trial studies whether starting preventive medicines on the very first day of capivasertib can lower how often moderate or worse rash and diarrhea. </li> <li class="seamTextUnorderedListItem">Researchers want to learn whether preventing these side effects helps people stay on capivasertib longer and feel better while on treatment.</li> <li class="seamTextUnorderedListItem">Capivasertib (Truqap®) is a targeted therapy that blocks a protein called AKT, which breast cancer cells can use to grow and survive. </li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), is a hormone therapy which works to slow or stop the activity of estrogen so hormone receptor positive cancer cells stop growing.</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/NCT07426822' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/truqap' target='_blank'>Breastcancer.org: Truqap (Capivasertib): What to Expect, Side Effects, and More</a> </li></ul>
1

Preventing Rash and Diarrhea From Capivasertib for Advanced Hormone Receptor Positive, HER2 Negative Breast Cancer With a PIK3CA, AKT1, or PTEN Mutation

A Phase II Trial to Improve Safety of Capivasertib for HR+/HER2- Metastatic Breast Cancer
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Nearest Location from 94107:
2615 miles
Yale University
New Haven, CT

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Visits:
About 1 to 2 times per month

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ClinicalTrials.gov: NCT07426822

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Phase II

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