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1

Belzutifan Targeted Therapy with Hormone Therapy for Advanced ER+, HER2- Breast Cancer

A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy (MK-6482-029/​LITESPARK-029)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of belzutifan (MK-6482), an experimental targeted therapy, with hormone therapy compared to standard of care targeted therapy and hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received at least 1 line of hormone therapy for advanced disease. You must not have received chemotherapy or a PARP inhibitor 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 Targeted Therapy with Hormone Therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Belzutifan (MK-6482), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Targeted Therapy with Hormone Therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly or exemestane (Aromasin®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Belzutifan (MK-6482) is an experimental targeted therapy called a HIF-2a inhibitor. Blocking HIF-2a may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Belzutifan (MK-6482) is approved for use in other cancers. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called a mTOR inhibitor. mTOR inhibitors work by interfering with the ability of cancer cells to divide and grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®) 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/NCT06428396' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healio.com/news/hematology-oncology/20240821/belzutifan-improves-pfs-response-in-advanced-renal-cell-carcinoma' target='_blank'>Healio: Belzutifan for Advanced Kidney Cancer</a> </li></ul>
1

Belzutifan Targeted Therapy with Hormone Therapy for Advanced ER+, HER2- Breast Cancer

A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy (MK-6482-029/​LITESPARK-029)
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Nearest Location:
186 miles
Renown Regional Medical Center ( Site 0018)
Reno, NV

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Visits:
About 1 visit every month

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ClinicalTrials.gov: NCT06428396

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Phase II

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