You have matched to 3 trials

Guest Profile:  No profile selected

Copy link
Sort by zip code: 94108 Hide Map Icon
mail-icon

Register to sign up for Trial Alerts

Receive emails about new trials that match your profile.
1

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

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?

<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">Lasofoxifene, by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <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?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05696626' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://sermonixpharma.com/lasofoxifene/' target='_blank'>Sermonix Pharmaceuticals: Lasofoxifene Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
1

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

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)
Icon

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

Icon

Visits:
Number of visits unavailable

Icon

ClinicalTrials.gov: NCT05696626

Icon

Phase III

2

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

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?

<p class="seamTextPara"> You will receive the following: </p> <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>
2

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

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

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

Icon

Visits:
1 visit every 3 to 4 weeks, ongoing

Icon

ClinicalTrials.gov: NCT04174352

Icon

Phase I

3

Dendritic Cell Vaccine and Hormone Therapy for Metastatic HR+, HER2- Breast Cancer with ESR1 Mutations

Immunologic Targeting of Native and Mutated ESR1 Receptor for Treatment of Hormone Receptor Expressing Metastatic Breast Cancer

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

Who is this for?: People with metastatic (stage IV) hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2- or HER2 low) breast cancer with ESR1 mutations. You must have received a CDK4/6 inhibitor with hormone therapy for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apheresis procedure to remove white blood cells, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, weekly for 2 months then monthly for 3 months</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The dendritic cell vaccine is an experimental immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">You will receive a dendritic cell vaccine made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The white blood cells, called dendritic cells, are removed from your body during a procedure called apheresis. These cells are processed in a lab so that they will see and go after cancer cells with ESR1 mutations, and then they will be injected as a vaccine.</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is considered standard of care for patients with ESR1 mutated HR+ HER2-metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2/ISH-.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</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/NCT06691035' target='_blank'>ClinicalTrials.gov</a> </li></ul>
3

Dendritic Cell Vaccine and Hormone Therapy for Metastatic HR+, HER2- Breast Cancer with ESR1 Mutations

Immunologic Targeting of Native and Mutated ESR1 Receptor for Treatment of Hormone Receptor Expressing Metastatic Breast Cancer
Icon

Nearest Location:
2396 miles
Moffitt Cancer Center
Tampa, FL

Icon

Visits:
Weekly for 2 months then monthly for 3 months

Icon

ClinicalTrials.gov: NCT06691035

Icon

Phase I

HELP GUIDE
HELP GUIDE