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Lasofoxifene Hormone Therapy with CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer With an ESR1 Mutation

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An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (ELAINEIII)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of lasofoxifene, an experimental hormone therapy, with abemaciclib (Verzenio®) CDK4/6 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with an ESR1 mutation. You must have received an aromatase inhibitor with palbociclib (Ibrance®) or ribociclib (Kisqali®) CDK4/6 inhibitor as your first line of hormone therapy for advanced disease. You must not have received more than 1 line of chemotherapy for advanced disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lasofoxifene, by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lasofoxifene is an experimental hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. It blocks 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 downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ESR1</li></ul>

How can I learn more?

Lasofoxifene Hormone Therapy with CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer With an ESR1 Mutation

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Nearest Location:
51 miles
Providence Medical Foundation - Santa Rosa, CA
Santa Rosa, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05696626

Phase III

Camizestrant with Targeted Therapy for Advanced HR+, HER2- Breast Cancer with an ESR1 Mutation

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A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor (Palbociclib or Abemaciclib) vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromata...

Purpose: To compare the safety and effects (good and bad) of camizestrant (AZD9833) and a CDK4/6 inhibitor with an aromatase inhibitor and a CDK4/6 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer and an ESR1 mutation. You must not have received treatment with fulvestrant (Faslodex®) or any investigational selective estrogen receptor degrader (SERD). View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 6 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily</li> </ul> Group 5 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for camizestrant (AZD9833), 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> Group 6 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), 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">Camizestrant (AZD9833) is an experimental type of anti-estrogen therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) and abemaciclib (Verzenio®) are CDK4/6 inhibitors, a type of targeted therapy.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) and anastrozole (Arimidex®) are aromatase inhibitors, a type of hormone therapy.</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ESR1</li></ul>

How can I learn more?

Camizestrant with Targeted Therapy for Advanced HR+, HER2- Breast Cancer with an ESR1 Mutation

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Nearest Location:
364 miles
Research Site
Long Beach, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04964934

Phase III

Samuraciclib CDK7 Inhibitor with Elacestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer with TP53 and ESR1 Mutations

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A Phase 1b/2 Open-label Study of Samuraciclib in Combination With Elacestrant in Participants With Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of elacestrant (Orserdu®) hormone therapy with samuraciclib, an experimental CDK7 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with TP53 and ESR1 mutations who are receiving or most recently received an aromatase inhibitor with a CDK4/6 inhibitor. You must not have received more than 1 line of hormone therapy for advanced disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Samuraciclib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Samuraciclib is an experimental targeted therapy called a CDK7 inhibitor. CDK7 inhibitors may block the CDK7 enzyme that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">If you are premenopausal or perimenopausal, you will also receive a drug that will put you in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: TP53, ESR1</li></ul>

How can I learn more?

Samuraciclib CDK7 Inhibitor with Elacestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer with TP53 and ESR1 Mutations

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Nearest Location:
679 miles
Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus
Seattle, WA

Visits:
1-2 visits every month

ClinicalTrials.gov: NCT05963997

Phase I-II

Imaging to Personalize Amount of Tamoxifen in Advanced, ER+, HER2- Breast Cancer With a ESR1 Mutation

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A Pilot Study of FES Imaging to Optimize Tamoxifen Dose for Metastatic Breast Cancer Patients With ESR1 Mutations

Purpose: To study if FES-PET/CT scans can help find a personalized dose of tamoxifen (Nolvadex®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV), estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer that tests positive for a ESR1 mutation. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">FES PET/CT scan, every 3 to 4 weeks, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is an anti-estrogen therapy used to treat hormone-sensitive breast cancer.</li> <li class="seamTextUnorderedListItem">ESR1 mutations in breast cancer may affect how well tamoxifen works against tumor cells. </li> <li class="seamTextUnorderedListItem">Tracers are chemicals that are used to find cancer cells in the body during a PET scan. The imaging trial will use the tracer fluoroestradiol (FES)--it finds estrogen receptors in breast tumors. </li> <li class="seamTextUnorderedListItem">The FES tracer may also show how tamoxifen is affecting your tumors. Researchers may use this information to increase your dose of tamoxifen.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ESR1</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/NCT04174352' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/research-and-advocacy/asco-care-and-treatment-recommendations-patients/hormonal-therapy-metastatic-breast-cancer' target='_blank'>ASCO Cancer.net: Hormonal Therapy for Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal/serms/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/more-effective-therapies-needed-for-patients-with-esr1mutated-breast-cancer' target='_blank'>Targeted Oncology: More Effective Therapies Needed For Patients With ESR1-Mutated Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.karger.com/Article/FullText/481428' target='_blank'>Journal Article: Are We Ready to Use ESR1 Mutations in Clinical Practice</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ijcem.com/files/ijcem0076055.pdf' target='_blank'>Journal Article: The Role of PET Imaging Probes for Early Monitoring the Response to Tamoxifen</a> </li></ul>

Imaging to Personalize Amount of Tamoxifen in Advanced, ER+, HER2- Breast Cancer With a ESR1 Mutation

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A Pilot Study of FES Imaging to Optimize Tamoxifen Dose for Metastatic Breast Cancer Patients With ESR1 Mutations

Nearest Location:
1678 miles
University of Wisconsin Carbone Cancer Center
Madison, WI

Visits:
1 visit every 3 to 4 weeks, ongoing

ClinicalTrials.gov: NCT04174352

Phase NA

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Lasofoxifene Hormone Therapy with CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer With an ESR1 Mutation

Lasofoxifene Hormone Therapy with CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer With an ESR1 Mutation

Camizestrant with Targeted Therapy for Advanced HR+, HER2- Breast Cancer with an ESR1 Mutation

Camizestrant with Targeted Therapy for Advanced HR+, HER2- Breast Cancer with an ESR1 Mutation

Samuraciclib CDK7 Inhibitor with Elacestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer with TP53 and ESR1 Mutations

Samuraciclib CDK7 Inhibitor with Elacestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer with TP53 and ESR1 Mutations

Imaging to Personalize Amount of Tamoxifen in Advanced, ER+, HER2- Breast Cancer With a ESR1 Mutation

Imaging to Personalize Amount of Tamoxifen in Advanced, ER+, HER2- Breast Cancer With a ESR1 Mutation