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1

Genomic Test Studying the Tumor Microenvironment for Advanced Breast Cancer

BostonGene and Exigent Genomic INsight (BEGIN) Study: A Prospective Study of Comprehensive Molecular Testing in Advanced Cancer Patients in the Community Setting

Purpose: To study the ability of the BostonGene Tumor Portrait test to provide information about tumors and their microenvironment and help make treatment decisions.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy, blood, saliva, and cheek swab samples for the BostonGene Tumor Portrait test</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The tumor microenvironment describes the cells that surround a tumor and plays a role in both how tumors grow and how they respond to treatment. </li> <li class="seamTextUnorderedListItem">The BostonGene Tumor Portrait test may help make treatment decisions for people with advanced cancer.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</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/NCT06272864' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/breast-cancer-and-tumor-microenvironment/' target='_blank'>Metastatic Trial Talk: The Tumor Microenvironment</a> </li></ul>
1

Genomic Test Studying the Tumor Microenvironment for Advanced Breast Cancer

BostonGene and Exigent Genomic INsight (BEGIN) Study: A Prospective Study of Comprehensive Molecular Testing in Advanced Cancer Patients in the Community Setting
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Nearest Location:
61 miles
Stockton Hematology Oncology Medical Group
Stockton, CA

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Visits:
Up to 2 years

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ClinicalTrials.gov: NCT06272864

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Phase NA

2

Genetic Testing for Diverse Groups of People with Breast Cancer

Gemini - Cancer Genetic Testing in Ethnic Populations

Purpose: To use genetic testing to identify genetic mutations and make treatment decisions.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genetic testing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genetic testing looks for changes, sometimes called mutations or variants, in your DNA.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</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/NCT04475640' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cdc.gov/genomics/gtesting/genetic_testing.htm' target='_blank'>Centers for Disease and Control: Genetic Testing</a> </li></ul>
2

Genetic Testing for Diverse Groups of People with Breast Cancer

Gemini - Cancer Genetic Testing in Ethnic Populations
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Nearest Location:
660 miles
Mayo Clinic in Arizona
Scottsdale, AZ

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04475640

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Phase NA

3

A Registry for People with Triple Negative or ER Low, HER2- Breast Cancer or an Inherited BRCA1/2 or Certain Other Mutations

PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations (PROGECT)

Purpose: To learn more about the relationship between genetic mutations and cancer outcomes.

Who is this for?: People with inherited BRCA1/2 mutations or certain other genetic mutations (see list below) and people with stage I, stage II, stage III, or stage IV triple negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> This is a data collection (registry) study. You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 blood test</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER Low breast cancer.</li> <li class="seamTextUnorderedListItem">Studies have found a relationship between triple negative breast cancer and inherited BRCA1 and BRCA2 mutations. </li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, PTEN, P53, and PALB2</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/NCT02302742' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.net/cancer-types/hereditary-breast-and-ovarian-cancer' target='_blank'>ASCO: Hereditary Breast and Ovarian Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://ww5.komen.org/BreastCancer/InheritedGeneticMutations.html' target='_blank'>Susan G. Komen: Inherited Gene Expressions</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://ghr.nlm.nih.gov/condition/breast-cancer' target='_blank'>NIH Genetics Home Reference: Breast Cancer</a> </li></ul>
3

A Registry for People with Triple Negative or ER Low, HER2- Breast Cancer or an Inherited BRCA1/2 or Certain Other Mutations

PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations (PROGECT)
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Nearest Location:
1251 miles
Hays Medical Center Dreiling-Schmidt Cancer Institute
Hays, KS

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Visits:
1 visit

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ClinicalTrials.gov: NCT02302742

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Phase NA

4

Genetic Testing Video for People with Metastatic HER2 Negative Breast Cancer

Efficacy of Point Of Service Testing in Metastatic Breast Cancer

Purpose: To study how watching a video about genetic testing affects people's decisions to receive genetic testing.

Who is this for?: People with metastatic (stage IV) HER2 negative (HER2-) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will complete the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Watch genetic testing video</li> <li class="seamTextUnorderedListItem">Surveys</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genetic testing looks for changes, sometimes called mutations or variants, in your DNA.</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/NCT03983577' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/genetic-testing' target='_blank'>Breastcancer.org: Genetic Testing</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/genetic-testing/what-to-expect' target='_blank'>Breastcancer.org: Genetic Counseling</a> </li></ul>
4

Genetic Testing Video for People with Metastatic HER2 Negative Breast Cancer

Efficacy of Point Of Service Testing in Metastatic Breast Cancer
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Nearest Location:
1502 miles
The University of Kansas Cancer Center, Westwood Campus
Kansas City, KS

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT03983577

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Phase NA

5

Hormone Therapy or Chemotherapy with Genetic Testing for Metastatic HR+, HER2- Breast Cancer

Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)

Purpose: To compare the safety, effects (good and bad), and anti-cancer activity of hormone therapy and capecitabine (Xeloda®) chemotherapy and use MammaPrint® and BluePrint tests to guide treatment decisions.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-), non-Luminal A breast cancer who have received treatment with an aromatase inhibitor or selective estrogen receptor modulator/downregulator (SERM/SERD) with a CDK4/6 inhibitor. You must not have received chemotherapy or more than 1 line of hormone therapy for advanced disease or have a PIK3CA mutation. 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: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy</li> <li class="seamTextUnorderedListItem">Provide tissue samples for MammaPrint® and BluePrint tests </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 1 week on, 1 week off</li> <li class="seamTextUnorderedListItem">Provide tissue samples for MammaPrint® and BluePrint tests</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">Capecitabine (Xeloda®) is a chemotherapy drug commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">MammaPrint® and BluePrint are genetic tests that use tumor samples to help guide treatment decisions.</li> <li class="seamTextUnorderedListItem">The tests will also be used to determine if certain mutations are potentially associated with resistance to therapy.</li> <li class="seamTextUnorderedListItem">Luminal A breast cancer is ER+, PR+, and HER2- with low Ki-67 levels, which controls how fast cancer cells grow. Luminal A cancers tend to grow more slowly.</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/NCT05693766' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/molecular-subtypes' target='_blank'>Breastcancer.org: Molecular Subtypes of Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/genetic-testing' target='_blank'>Breastcancer.org: Genetic Testing for Breast Cancer</a> </li></ul>
5

Hormone Therapy or Chemotherapy with Genetic Testing for Metastatic HR+, HER2- Breast Cancer

Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)
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Nearest Location:
1509 miles
UT Southwestern Medical Center
Dallas, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05693766

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Phase II

6

Biomarkers to Detect Resistance to Hormone Therapy for Advanced HR+, HER2- Lobular Breast Cancer

Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer

Purpose: To identify possible biomarkers of response to hormone therapy for advanced lobular breast cancer.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2-) lobular breast cancer (LBC) who are planning to receive hormone therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PET/CT scans with 18F-FFNP, by IV, 2 times, at baseline and at 1 month</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times, at baseline and at 1 month</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biomarkers are genes, molecules, or other features present in a person, including in a person’s tumor, that tell doctors something about a person’s health condition.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">The tracer used in this study is 18F-FFNP.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy. MRI scans study the blood vessels in the tumor. PET/CT scans study if the tumor cells are growing.</li> <li class="seamTextUnorderedListItem">The blood samples will be used to conduct DNA and circulating tumor cell (CTC) testing.</li> <li class="seamTextUnorderedListItem">Circulating tumor cells (CTCs) are cancer cells from a tumor that circulate in the bloodstream.</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/NCT06067503' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/biomarker-testing-cancer-treatment' target='_blank'>National Cancer Institute: Biomarker Testing</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/pet-scans' target='_blank'>Breastcancer.org: PET Scans</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/ct-scan' target='_blank'>Breastcancer.org: CT Scans</a> </li></ul>
6

Biomarkers to Detect Resistance to Hormone Therapy for Advanced HR+, HER2- Lobular Breast Cancer

Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer
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Nearest Location:
1678 miles
UW Carbone Cancer Center
Madison, WI

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Visits:
2 visits within 1 month

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ClinicalTrials.gov: NCT06067503

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Phase II

7

Biomarker Test to Change or Continue Treatment for Advanced HR+, HER2- Breast Cancer

BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer

Purpose: To use the DiviTum® TKa blood test to determine if people with advanced HR+, HER2- breast cancer should continue or switch treatments.

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 who have not yet received treatment for advanced disease. You must be planning to receive hormone therapy with a CDK4/6 inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups depending on results of the DiviTum® TKa blood tests: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Suppressed (Low) TKa Levels</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DiviTum® TKa blood test, 4 times within 4 months</li> <li class="seamTextUnorderedListItem">Continue on endocrine therapy and CDK4/6 inhibitor (i.e., Ribociclib)</li> <li class="seamTextUnorderedListItem">Imaging scans</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Unsuppressed (Not Low) TKa Levels</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DiviTum® TKa blood test, 4 times within 4 months</li> <li class="seamTextUnorderedListItem">Switch treatment</li> <li class="seamTextUnorderedListItem">Imaging scans</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DiviTum® TKa blood test is a blood test that measures thymidine kinase activity (TKa) which may predict how well tumors respond to treatment.</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/NCT05977036' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://biovica.com/divitum/' target='_blank'>Biovica: DiviTum® Test</a> </li></ul>
7

Biomarker Test to Change or Continue Treatment for Advanced HR+, HER2- Breast Cancer

BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer
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Nearest Location:
1739 miles
Washington University School of Medicine
Saint Louis, MO

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Visits:
At least 4 visits within 4 months

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ClinicalTrials.gov: NCT05977036

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Phase NA

8

Guardant360 Blood Test to Measure Treatment Response for People with Advanced Breast Cancer

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Purpose: To collect information to develop a Guardant360 blood test that can measure treatment response.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) who have received 0-1 lines of therapy 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">Guardant360 blood test</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Guardant360 is a blood test that identifies genomic biomarkers and mutations to help make treatment decisions.</li> <li class="seamTextUnorderedListItem">This trial is collecting information to develop a future version of Guardant360 that can measure treatment response.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</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/NCT05935384' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/tumor-marker-tests' target='_blank'>Breastcancer.org: Breast Cancer Biomarkers and Biomarker Tests</a> </li><li class='seamTextUnorderedListItem'><a href='https://guardanthealth.com/products/tests-for-patients-with-advanced-cancer/' target='_blank'>Guardant Health: Guardant360 Test Information Page</a> </li></ul>
8

Guardant360 Blood Test to Measure Treatment Response for People with Advanced Breast Cancer

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
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Nearest Location:
1849 miles
Orchard Healthcare Research Inc.
Skokie, IL

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05935384

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Phase NA

9

OmniSeq Test to Detect Biomarkers and Mutations in People with Advanced Breast Cancer

PRospective rEgistry OF Advanced Stage cancER (PREFER) Patients to Assess Prevalence of Actionable Biomarkers and Driver Mutations Using the OmniSeq Test and Creation of a Biobank From Community Cancer Clinics in the United States to Address Disparities in Precision Medicine

Purpose: To study the ability of the OmniSeq Test to detect biomarkers and mutations compared to a liquid biopsy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood and/or tissue samples for OmniSeq Test</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The OmniSeq Test is a genomic test that detects biomarkers and mutations for many types of cancer.</li> <li class="seamTextUnorderedListItem">The OmniSeq Test may help your doctor select your treatment based on detected biomarkers and mutations.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</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/NCT05697198' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://oncology.labcorp.com/cancer-care-team/test-menu/omniseq-insight' target='_blank'>Labcorp: OmniSeq Test</a> </li></ul>
9

OmniSeq Test to Detect Biomarkers and Mutations in People with Advanced Breast Cancer

PRospective rEgistry OF Advanced Stage cancER (PREFER) Patients to Assess Prevalence of Actionable Biomarkers and Driver Mutations Using the OmniSeq Test and Creation of a Biobank From Community Cancer Clinics in the United States to Address Disparities in Precision Medicine
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Nearest Location:
1906 miles
Clinical Site
Covington, LA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05697198

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Phase NA

10

Blood Test to Predict Response to Treatment for Women with Metastatic HR+ Breast Cancer

DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients

Purpose: To study the ability of the DiviTum®TKa blood test to predict response to treatment for women with metastatic hormone receptor positive breast cancer.

Who is this for?: Women with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+) breast cancer who are planning to receive or currently receiving hormone therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DiviTum®TKa blood test, every 2 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DiviTum®TKa is an experimental blood test that measures thymidine kinase activity (TKa) which may predict how well tumors respond to treatment.</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/NCT06388122' target='_blank'>ClinicalTrials.gov</a> </li></ul>
10

Blood Test to Predict Response to Treatment for Women with Metastatic HR+ Breast Cancer

DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients
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Nearest Location:
2383 miles
Mayo Clinic in Florida
Jacksonville, FL

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Visits:
1 visit every 2 weeks

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ClinicalTrials.gov: NCT06388122

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Phase NA

11

Studying Biomarkers, Immune Cells, and ctDNA in People with Brain Metastasis

Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors

Purpose: To study biomarkers, immune cells, and circulating tumor (ctDNA) in blood samples after radiation.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive or receiving radiation at Duke Cancer Center. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood samples</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests will be used for genetic testing to indicate the presence of biomarkers, immune cells, and circulating tumor (ctDNA).</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small pieces of cancer cell DNA in the bloodstream.</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/NCT05480644' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
11

Studying Biomarkers, Immune Cells, and ctDNA in People with Brain Metastasis

Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors
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Nearest Location:
2385 miles
Duke Cancer Center
Durham, NC

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Visits:
Coincides with routine care

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ClinicalTrials.gov: NCT05480644

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Phase NA

12

Web-Based Genetic Counseling for Metastatic Breast Cancer

A Randomized Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Breast, Ovarian, Prostate and Pancreatic Cancer Patients

Purpose: To study whether web-based genetic counseling can improve genetic testing knowledge and decrease anxiety.

Who is this for?: People with metastatic (stage IV) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Visits with a genetic counselor, 2 times, before and after genetic testing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Visit with a genetic counselor, 1 time, before genetic testing</li> <li class="seamTextUnorderedListItem">Web-based genetic counseling, 1 time, after genetic testing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Web-based genetic counseling, 1 time, before genetic testing</li> <li class="seamTextUnorderedListItem">Visit with a genetic counselor, 1 time, after genetic testing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Web-based genetic counseling, 2 times, before and after genetic testing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Visits with genetic counselors will be either in-person or remote (telephone or video).</li> <li class="seamTextUnorderedListItem">Visits with a genetic counselor before and after genetic testing are considered standard of care. Genetic counselors provide you information about how genetic conditions could affect you or your family.</li> <li class="seamTextUnorderedListItem">Web-based genetic counseling provides your genetic testing results, a detailed summary of what those results mean, and an individualized summary.</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/NCT04353973' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cdc.gov/genomics/gtesting/genetic_counseling.htm' target='_blank'>CDC: What is Genetic Counseling?</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicalresearch.itmat.upenn.edu/clinicaltrial/6565/a-randomized-study-of-an-ehealth-delivery-alternative-for-cancer-genetic-testing-for-hereditary-predisposition-in-metastatic-breast-ovarian-prostate-and-pancreatic-cancer-patients/?qd=2667811' target='_blank'>University of Pennsylvania: Trial Information Page</a> </li></ul>
12

Web-Based Genetic Counseling for Metastatic Breast Cancer

A Randomized Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Breast, Ovarian, Prostate and Pancreatic Cancer Patients
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Nearest Location:
2517 miles
Abramson Cancer Center at University of Pennsylvania
Philadelphia, PA

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Visits:
4 visits within 6 months

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ClinicalTrials.gov: NCT04353973

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Phase NA

13

Tumor Test to Predict Response to Enhertu® for People with Metastatic HER2 Low Breast Cancer

QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer

Purpose: To study the ability of the CE-10-IVD test to predict treatment response to trastuzumab deruxtecan (T-DXd, Enhertu®).

Who is this for?: People with stage IV (metastatic) HER2 low (IHC 1+) breast cancer who are planning to receive or are receiving (within 1 month) trastuzumab deruxtecan (T-DXd, Enhertu®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor tissue from most recent biopsy, for CE-10-IVD test</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The CE-10-IVD test measures the amount of HER2 positive (HER2+) breast cancer cells, which may relate to your response to trastuzumab deruxtecan (T-DXd, Enhertu®), an anti-HER2 targeted therapy.</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/NCT06551116' target='_blank'>ClinicalTrials.gov</a> </li></ul>
13

Tumor Test to Predict Response to Enhertu® for People with Metastatic HER2 Low Breast Cancer

QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
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Nearest Location:
2517 miles
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, PA

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Visits:
Coincides with routine care

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ClinicalTrials.gov: NCT06551116

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Phase NA

14

Studying Genetic and Molecular Biomarkers of Breast Cancer in Black Women or Men

African Cancer Genome Cohort to Promote Health Equity Among Patients of African Ancestry: Characterization of Genetic and Molecular Drivers

Purpose: To study genetic and molecular biomarkers of breast cancer in individuals of African ancestry.

Who is this for?: Black women or men with stage I, stage II, stage III, or stage IV (metastatic) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will complete the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Provide blood and tumor tissues</li> <li class="seamTextUnorderedListItem">Receive genetic testing</li> <li class="seamTextUnorderedListItem">Complete social determinants of health (SDOH) survey</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial will also identify the effects of social determinants of health (SDOH) and lifestyle factors on breast cancer mutations.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</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/NCT05754658' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cdc.gov/about/priorities/why-is-addressing-sdoh-important.html#:~:text=Social%20determinants%20of%20health%20(SDOH)%20are%20the%20nonmedical%20factors%20that,live%2C%20worship%2C%20and%20age.' target='_blank'>Centers for Disease Control and Prevention: Social Determinants of Health (SDOH)</a> </li></ul>
14

Studying Genetic and Molecular Biomarkers of Breast Cancer in Black Women or Men

African Cancer Genome Cohort to Promote Health Equity Among Patients of African Ancestry: Characterization of Genetic and Molecular Drivers
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Nearest Location:
2521 miles
Fox Chase Cancer Center
Philadelphia, PA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05754658

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Phase NA

15

Developing Genetic Testing Education for Diverse Groups of People with Breast Cancer

Prospective Trial of a Linguistically and Culturally Appropriate Mainstreaming Model for Hereditary Cancer Multigene Panel Testing Among Diverse Cancer Patients

Purpose: To develop educational materials about genetic testing for people that speak different languages and have diverse cultural backgrounds.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Interview</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genetic testing is a type of test that detects changes to the genes, the DNA instructions that are passed on from the mother and father.</li> <li class="seamTextUnorderedListItem">The results of a genetic test can confirm whether the participant has a genetic disorder, which is a disease caused in whole or in part by changes to the genes. Genetic testing can also help determine a person's chance of getting or passing on a genetic disorder.</li> <li class="seamTextUnorderedListItem">The information gathered from your interview will be used to develop educational materials about genetic testing.</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/NCT04751435' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cdc.gov/genomics/gtesting/genetic_testing.htm' target='_blank'>Centers for Disease Control and Prevention: Genetic Testing</a> </li></ul>
15

Developing Genetic Testing Education for Diverse Groups of People with Breast Cancer

Prospective Trial of a Linguistically and Culturally Appropriate Mainstreaming Model for Hereditary Cancer Multigene Panel Testing Among Diverse Cancer Patients
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Nearest Location:
2570 miles
Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)
New York, NY

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04751435

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Phase NA

16

Blood Test to Identify CDK4/6 Inhibitor Levels in Blood for Women with Metastatic ER+, HER2- or HER2 Low Breast Cancer

Use of DiviTum-TKa as a Biomarker Assay for CDK4/6 Inhibitor Medication Compliance and Drug-Drug Interaction Assessment in ER/PR Positive Metastatic Breast Cancer

Purpose: To study if the DiviTum-TKa blood test can identify and optimize levels of CDK4/6 inhibitors in the blood, help improve taking medication as prescribed, and remove potential drug-drug interactions.

Who is this for?: Women newly diagnosed with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2- or HER2 low) breast cancer who are planning to receive a CDK4/6 inhibitor with hormone therapy as their first line of 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">DiviTum-TKa blood tests, 1-3 times every month for up to 1 year</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A CDK4/6 inhibitor with hormone therapy is the first line of therapy for people with metastatic hormone receptor positive (HR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Thymidine kinase is a biomarker (biological molecule found in blood, other body fluids, or tissues that is a sign of a condition or disease) that reflects cell proliferation (an increase in the number of cells as a result of cell growth and cell division).</li> <li class="seamTextUnorderedListItem">DiviTum-thymidine kinase activity (TKa) is an FDA approved blood test.</li> <li class="seamTextUnorderedListItem">The DiviTum-TKa blood test shows that TKa levels are associated with a lower risk of disease progression within 1-2 months of the blood test.</li> <li class="seamTextUnorderedListItem">Using the DiviTum-TKa blood test may improve taking medication as prescribed and remove potential drug-drug interactions.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is IHC 1+ or IHC 2+/FISH-.</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/NCT06572800' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://divitum.com/' target='_blank'>Biovica: DiviTum-TKa Information Page</a> </li></ul>
16

Blood Test to Identify CDK4/6 Inhibitor Levels in Blood for Women with Metastatic ER+, HER2- or HER2 Low Breast Cancer

Use of DiviTum-TKa as a Biomarker Assay for CDK4/6 Inhibitor Medication Compliance and Drug-Drug Interaction Assessment in ER/PR Positive Metastatic Breast Cancer
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Nearest Location:
2582 miles
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, CT

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Visits:
1-3 visits every month for up to 1 year

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ClinicalTrials.gov: NCT06572800

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Phase NA

17

Free-HER: Stopping Maintenance Anti-HER2 Targeted Therapy for People with Metastatic HER2+ Breast Cancer and No Evidence of Disease

Free-HER: Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer

Purpose: To study if people who stop taking anti-HER2 targeted therapy for maintenance will stay in complete remission.

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer who have been in complete remission, also called no evidence of disease (NED), for at least 3 years and have been receiving anti-HER2 targeted therapy for at least 3 years. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stop taking anti-HER2 targeted therapy</li> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Imaging scans</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a type of anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Complete remission is also known as no evidence of disease (NED).</li> <li class="seamTextUnorderedListItem">Blood tests will measure circulating tumor DNA (ctDNA), which are small pieces of cancer cell DNA in the bloodstream.</li> <li class="seamTextUnorderedListItem">You will continue to receive routine monitoring, blood tests, and imaging scans.</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/NCT05959291' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: What is Anti-HER2 Targeted Therapy?</a> </li></ul>
17

Free-HER: Stopping Maintenance Anti-HER2 Targeted Therapy for People with Metastatic HER2+ Breast Cancer and No Evidence of Disease

Free-HER: Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer
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Nearest Location:
2591 miles
University of Miami
Miami, FL

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05959291

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Phase NA

18

ctDNA Blood Tests to Determine an Early Switch in Treatment for Metastatic ER+, HER2- or HER2 Low Breast Cancer

Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer: A Phase 2 Randomized, Open-Label Study

Purpose: To determine whether switching treatment earlier will increase the amount of time that metastatic breast cancer is controlled.

Who is this for?: People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low breast cancer who have not yet received treatment 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: No Treatment Change</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ctDNA test, monthly for 2 months, then every 2 months</li> <li class="seamTextUnorderedListItem">Standard of care: CDK4/6 inhibitor with aromatase inhibitor or CDK4/6 inhibitor with selective estrogen receptor degrader (SERD)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Switch to new treatment (if progression occurs, optional)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Early Treatment Change</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ctDNA test, monthly for 2 months, then every 2 months</li> <li class="seamTextUnorderedListItem">Standard of care: CDK4/6 inhibitor with aromatase inhibitor or CDK4/6 inhibitor with selective estrogen receptor degrader (SERD)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Early switch to a new treatment, for 1 year 2 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests will be used to indicate tumor biomarkers and the presence of circulating tumor (ctDNA).</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is define as IHC 1+ or 2+/FISH-.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®) are types of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">If you are premenopausal, you must also take a drug that will put women in temporary menopause.</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/NCT05826964' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/ctdna-mbc/' target='_blank'>Metastatic Trial Talk: The Latest Research on ctDNA and MBC</a> </li></ul>
18

ctDNA Blood Tests to Determine an Early Switch in Treatment for Metastatic ER+, HER2- or HER2 Low Breast Cancer

Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer: A Phase 2 Randomized, Open-Label Study
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Nearest Location:
2591 miles
University of Miami
Miami, FL

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Visits:
At least 1 visit every 2 months

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ClinicalTrials.gov: NCT05826964

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Phase II

19

Hormone Therapy and Targeted Therapy Based on Biomarker Testing for Advanced ER+, HER2- Breast Cancer

Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of hormone therapy and targeted therapy based on biomarker testing.

Who is this for?: Post-menopausal women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) or ER low, HER2 negative (HER2-) or HER2 low breast cancer. You must have received treatment with palbociclib (Ibrance®), ribociclib (Kisqali®), or abemaciclib (Verzenio®) for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 4 groups based on biomarker testing results: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 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">You will receive treatment based on ERBB2, PIK3CA, AKT1, MTOR, PTEN, and RB1 biomarker testing results.</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">Neratinib (Nerlynx®) is an anti-HER2 targeted therapy that stops cancer cells from growing by targeting and blocking the HER2 proteins that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/FISH -.</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/NCT05933395' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/nerlynx' target='_blank'>Breastcancer.org: Neratinib (Nerlynx®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/afinitor' target='_blank'>Breastcancer.org: Everolimus (Afinitor®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>
19

Hormone Therapy and Targeted Therapy Based on Biomarker Testing for Advanced ER+, HER2- Breast Cancer

Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE)
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Nearest Location:
2619 miles
Dartmouth Hitchcock Medical Center
Lebanon, NH

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Visits:
1 visit every month

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ClinicalTrials.gov: NCT05933395

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Phase II

20

A Study of the Inherited KRAS-Variant Mutation and Breast Cancer Risk

Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment

Purpose: To analyze the association between the KRAS-variant mutation and cancer risk.

Who is this for?: People with stage I, stage II, stage III or metastatic (stage IV) breast cancer View full eligibility criteria

What's involved?

<p class="seamTextPara"> All participants will provide a saliva sample and answer questionnaires periodically over 10 years. Participants will be able to get their KRAS-variant test results after submitting their sample, at a discounted cost ($295). </p> <p class="seamTextPara"> Click here for the <a href="http://mirakind.org/study-eligibility-questionnaire/">Eligibility Survey</a></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">An inherited genetic mutation, a KRAS-variant, may increase a person's risk of developing breast or other types of cancer. </li> <li class="seamTextUnorderedListItem">This study will follow participants for 10 years. </li> <li class="seamTextUnorderedListItem">The researchers will also look at the effect that different lifestyle factors have on cancer risk. </li> <li class="seamTextUnorderedListItem">All participants will have a saliva sample tested for the KRAS-variant. </li> <li class="seamTextUnorderedListItem">To be eligible, participants must have a personal or family history of breast cancer.</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/NCT02253251' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://mirakind.org/wp-content/uploads/2014/03/Understanding_Results.pdf' target='_blank'>MiraKind.org: KRAS-Variant</a> </li><li class='seamTextUnorderedListItem'><a href='https://miradx.com/test/kras-variant/' target='_blank'>MiraDx: KRAS-Variant Testing</a> </li><li class='seamTextUnorderedListItem'><a href='http://mirakind.org/study-eligibility-questionnaire/' target='_blank'>MiraKind Eligibility Survey</a> </li></ul>
20

A Study of the Inherited KRAS-Variant Mutation and Breast Cancer Risk

Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment
No Travel Required
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Visits:
Saliva sample and questionnaires

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ClinicalTrials.gov: NCT02253251

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Phase NA

21

Empowerment and Navigation Sessions for Latina Women Ages 30+ with Breast Cancer or a Family History of Breast/Ovarian Cancer

Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care

Purpose: To compare the impact of empowerment and navigation sessions with standard of care sessions on whether Latina women decide to receive genetic testing and/or genetic counseling.

Who is this for?: Latina women ages 30+ with stage I, stage II, stage III, or stage IV (metastatic) breast cancer or with a family history of breast or ovarian cancer. You must have one social determinant of health risk factor, such as: perceived financial struggles, transportation difficulties, exposure to violence, housing challenges, social isolation/challenges. You must not have received genetic testing or genetic counseling. 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">Empowerment and navigation sessions, by phone, 3 times within 3 weeks</li> <li class="seamTextUnorderedListItem">Personalized educational materials</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care sessions, by phone, 3 times within 3 weeks</li> <li class="seamTextUnorderedListItem">Personalized educational materials</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Empowerment and navigation sessions will discuss social determinants of heath, genetic risk factors, individual behavior change action plans, breast cancer screening, and diet and physical activity for breast cancer prevention.</li> <li class="seamTextUnorderedListItem">Standard of care sessions will discuss social determinants of heath, genetic risk factors, individual behavior change action plans, how to share breast cancer information, and testimonials and include role playing activities and group discussions.</li> <li class="seamTextUnorderedListItem">You can receive up to $100 for participation.</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/NCT05483283' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/cancer-prevention-and-early-detection-facts-and-figures/making-the-case-for-health-equity.pdf' target='_blank'>American Cancer Society: Health Equity and Social Determinants of Health</a> </li><li class='seamTextUnorderedListItem'><a href='https://health.gov/healthypeople/priority-areas/social-determinants-health' target='_blank'>US Department of Health and Human Services: Social Determinants of Health</a> </li></ul>
21

Empowerment and Navigation Sessions for Latina Women Ages 30+ with Breast Cancer or a Family History of Breast/Ovarian Cancer

Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care
No Travel Required
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Visits:
No visits required

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ClinicalTrials.gov: NCT05483283

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Phase NA

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Genetic Testing Educational Video for People with Stage I-IV Breast Cancer

Video Education With Result Dependent dIsclosure

Purpose: To study if an educational video improves knowledge of genetic testing for inherited cancer risk and could be used as an alternative to genetic counseling before genetic testing.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who have not received genetic testing. 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: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Watch educational video about genetic testing for inherited cancer risk</li> <li class="seamTextUnorderedListItem">Complete interview, by video or telephone</li> <li class="seamTextUnorderedListItem">Questionnaires, 2 times in 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive genetic counseling</li> <li class="seamTextUnorderedListItem">Questionnaires, 2 times in 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The video summarizes the core educational components of a genetic counseling visit.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</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/NCT05225428' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cdc.gov/genomics/gtesting/genetic_testing.htm' target='_blank'>Centers for Disease Control and Prevention: Genetic Testing</a> </li></ul>
22

Genetic Testing Educational Video for People with Stage I-IV Breast Cancer

Video Education With Result Dependent dIsclosure
No Travel Required
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Visits:
No visits required

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ClinicalTrials.gov: NCT05225428

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Phase NA

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