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1

ComboMATCH: Targeted Therapy Directed by Genetic Testing for Advanced Breast Cancer

Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Purpose: To use genetic testing to match people to treatments and help doctors plan better treatments.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received at least 1 line of therapy for advanced disease or who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy based on genetic testing</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">Genetic tests look at the unique genetic material (genes) of tumor cells.</li> <li class="seamTextUnorderedListItem">People with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: AKT, ERK, MEK, NF1, RAF, RAS</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/NCT05564377' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/press-releases/2023/combomatch-precision-medicine-cancer-initiative' target='_blank'>National Cancer Institute: ComboMATCH</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/precision-medicine-breast-cancer/about/pac-20385240' target='_blank'>Mayo Clinic: Precision Medicine for Breast Cancer</a> </li></ul>
1

ComboMATCH: Targeted Therapy Directed by Genetic Testing for Advanced Breast Cancer

Molecular Analysis for Combination Therapy Choice (ComboMATCH)
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Nearest Location:
3 miles
UCSF Medical Center-Mission Bay
San Francisco, CA

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Visits:
Please contact research site

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ClinicalTrials.gov: NCT05564377

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Phase II

2

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>
2

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:
3 miles
University of California San Francisco Medical Center
San Francisco, CA

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Visits:
Coincides with routine care

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ClinicalTrials.gov: NCT06551116

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Phase NA

3

Studying HLA Gene Changes and Storing Immune Cells for Future Immunotherapy for Advanced Triple Negative Breast Cancer

An Observational Study Obtaining Solid Tumor Tissue from Participants and Apheresis for CAR T-Cell Therapy Manufacturing (BASECAMP-1)

Purpose: To study if tumors have HLA gene changes and to store immune cells that will be used to create a future immunotherapy treatment.

Who is this for?: People with some stage III (advanced) or stage IV (metastatic) triple negative (ER-, PR-, HER2-) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood or saliva (spit) sample for HLA gene testing</li> <li class="seamTextUnorderedListItem">Apheresis</li> <li class="seamTextUnorderedListItem">CAR T-cell therapy if the cancer comes back</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">One reason tumors may grow is because of changes in the HLA gene.</li> <li class="seamTextUnorderedListItem">When HLA is mutated (changed), your immune system loses the ability to recognize the cancer.</li> <li class="seamTextUnorderedListItem">Apheresis is a type of blood draw that collects white blood cells.</li> <li class="seamTextUnorderedListItem">CAR-T cell therapy is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your cells will be stored to create a CAR T-cell therapy if your cancer returns.</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/NCT04981119' target='_blank'>ClinicalTrials.gov</a> </li></ul>
3

Studying HLA Gene Changes and Storing Immune Cells for Future Immunotherapy for Advanced Triple Negative Breast Cancer

An Observational Study Obtaining Solid Tumor Tissue from Participants and Apheresis for CAR T-Cell Therapy Manufacturing (BASECAMP-1)
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Nearest Location:
28 miles
Stanford University
Palo Alto, CA

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Visits:
At least 2 visits in 1 week

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ClinicalTrials.gov: NCT04981119

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Phase NA

4

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>
4

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

5

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>
5

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

6

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>
6

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

7

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-) breast cancer who have received treatment with hormone therapy and 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">This trial is for people with non-Luminal A breast cancer. 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>
7

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

8

Blood Sample Collection to Better Predict Breast Cancer Risk for Healthy Women

Integrating Molecular Pathology, Radiology, and Genetics to Improve Breast Cancer Risk

Purpose: To study genetic and other factors to learn how non-cancerous breast diseases might lead to breast cancer.

Who is this for?: Women who had a breast biopsy at Mayo Clinic between 2002-2022 that was not cancer. You must not have been diagnosed with breast cancer within 6 months of this biopsy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Provide blood or saliva (spit) sample</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Features in the blood and breast tissue from people with non-cancerous breast disease may help predict breast cancer risk.</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/NCT07207564' target='_blank'>ClinicalTrials.gov</a> </li></ul>
8

Blood Sample Collection to Better Predict Breast Cancer Risk for Healthy Women

Integrating Molecular Pathology, Radiology, and Genetics to Improve Breast Cancer Risk
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Nearest Location:
1615 miles
Mayo Clinic in Rochester
Rochester, MN

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Visits:
1 visit

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ClinicalTrials.gov: NCT07207564

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Phase NA

9

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>
9

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

10

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>
10

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
St 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

11

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>
11

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

12

Pharmacogenomics Testing to Make Chemotherapy Dosing Decisions for People with Breast Cancer

PhOCus: Implementation of Pharmacogenomic Testing in Oncology Care

Purpose: To study if pharmacogenomics testing, a type of genetic testing, helps doctors make chemotherapy dosing decisions and decreases chemotherapy side effects.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive chemotherapy. You must be receiving care at The University of Chicago Medical Center. 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">Receive chemotherapy</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Provide DNA samples for pharmacogenomics testing, after chemotherapy treatment</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Provide DNA samples for pharmacogenomics testing</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive chemotherapy based on pharmacogenomics testing results</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doctors leading the study will collect your genetic information using pharmacogenomics/genotyping, a type of genetic testing.</li> <li class="seamTextUnorderedListItem">Pharmacogenomics is the study of how the differences in our genes can affect our unique response to medications.</li> <li class="seamTextUnorderedListItem">If you are in Group 2, your doctor will use your test results to make dosing decisions/changes to your chemotherapy 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/NCT04541381' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://nigms.nih.gov/education/fact-sheets/Pages/pharmacogenomics.aspx#:~:text=Pharmacogenomics%20(sometimes%20called%20pharmacogenetics)%20is,best%20suited%20for%20each%20person.' target='_blank'>National Institutes of Health: Pharmacogenomics</a> </li></ul>
12

Pharmacogenomics Testing to Make Chemotherapy Dosing Decisions for People with Breast Cancer

PhOCus: Implementation of Pharmacogenomic Testing in Oncology Care
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Nearest Location:
1857 miles
University of Chicago Medical Center
Chicago, IL

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04541381

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Phase NA

13

ctDNA Tests to Support Treatment Decisions for People with Metastatic Triple Negative, PD-L1 Negative Breast Cancer

A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer

Purpose: To study how well circulating tumor DNA (ctDNA) tests work to support decisions to change treatment.

Who is this for?: People with metastatic (stage IV) triple negative (ER-, PR-, HER2-), PD-L1 negative breast cancer who have not received chemotherapy for metastatic 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: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> <li class="seamTextUnorderedListItem">Blood samples for ctDNA tests</li> <li class="seamTextUnorderedListItem">CT scan or MRI scan, 2 times</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> <li class="seamTextUnorderedListItem">Blood samples for ctDNA tests</li> <li class="seamTextUnorderedListItem">CT scan or MRI scan, 2 times</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Switch to sacituzumab govitecan (Trodelvy®), by IV (depending on blood test results)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <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">Studying ctDNA may help your doctor decide to change your treatment earlier (if needed) and may improve your health outcomes.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</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/NCT05770531' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/trodelvy' target='_blank'>Breastcancer.org: Sacituzumab Govitecan (Trodelvy®)</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>
13

ctDNA Tests to Support Treatment Decisions for People with Metastatic Triple Negative, PD-L1 Negative Breast Cancer

A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer
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Nearest Location:
1958 miles
Vanderbilt University/Ingram Cancer Center
Nashville, TN

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Visits:
Coincides with routine care

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ClinicalTrials.gov: NCT05770531

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Phase II

14

Liquid Biopsy to Monitor Treatment Response for Women with Metastatic Lobular ER+ Breast Cancer

LBC-Monitor: Liquid Biopsy Guided Tailoring of Therapy in Metastatic Lobular Breast Cancer (mILC): a Pilot Study of Longitudinal Tumor Burden Quantification Using Circulating Tumor DNA

Purpose: To study how circulating tumor DNA (ctDNA) changes over time to help monitor treatment response and make treatment decisions.

Who is this for?: Women with metastatic (stage IV) estrogen receptor positive (ER+) or ER low, HER2 negative (HER2-) lobular breast cancer who have not yet received treatment 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">Blood tests, 4 times in 3 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lobular breast cancer can be difficult to see and monitor on scans.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small pieces of cancer cell DNA in the bloodstream.</li> <li class="seamTextUnorderedListItem">A ctDNA test is sometimes called a liquid biopsy.</li> <li class="seamTextUnorderedListItem">ctDNA tests may improve the ability to monitor treatment response in lobular breast cancer and identify changes in the tumor cells that may predict resistance to hormone therapy.</li> <li class="seamTextUnorderedListItem">This information may allow doctors to change treatments when it is most beneficial to patients.</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/NCT06666439' target='_blank'>ClinicalTrials.gov</a> </li></ul>
14

Liquid Biopsy to Monitor Treatment Response for Women with Metastatic Lobular ER+ Breast Cancer

LBC-Monitor: Liquid Biopsy Guided Tailoring of Therapy in Metastatic Lobular Breast Cancer (mILC): a Pilot Study of Longitudinal Tumor Burden Quantification Using Circulating Tumor DNA
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Nearest Location:
2264 miles
Magee Women's Hospital of UPMC
Pittsburgh, PA

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Visits:
4 visits in 3 months

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ClinicalTrials.gov: NCT06666439

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Phase NA

15

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>
15

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

16

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>
16

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

17

Increasing Biomarker-Informed Treatment for Metastatic Breast Cancer

PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival

Purpose: To study whether intervention from a navigator and expert review of results of DNA analysis by a pharmacist will increase ordering of biomarker-informed therapy compared to an estimated historical rate of 15% and enrollment in biomarker-informed clinical trials.

Who is this for?: People with stage IV (metastatic) breast cancer for whom biomarker testing is considered appropriate but who have not received it. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Provide blood or tissue samples</li> <li class="seamTextUnorderedListItem">Review of your biomarker results by an expert</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biomarkers are genes, molecules, or other features present in a person that tell doctors something about that person’s health.</li> <li class="seamTextUnorderedListItem">Patients with cancer have better outcomes when their treatments are selected with the help of biomarker testing. However, genomic testing, which is a type of biomarker testing, is not used as often as it should be.</li> <li class="seamTextUnorderedListItem">This trial is studying whether making biomarker test ordering and interpretation easier for clinicians will increase the rate of biomarker-informed 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/NCT06896162' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/new-biomarkers/' target='_blank'>Metastatic Trial Talk: Biomarkers for Selection of MBC Treatment</a> </li></ul>
17

Increasing Biomarker-Informed Treatment for Metastatic Breast Cancer

PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival
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Nearest Location:
2406 miles
Lineberger Comprehensive Cancer Center, University of North Carolina
Chapel Hill, NC

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06896162

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Phase NA

18

Video Versus Fact Sheet to Increase Genetic Counseling and Testing for Latina Women With Stage 0-IV Breast Cancer or High-Risk Women

Testing a Narrative Intervention to Enhance Genetic Counseling and Testing (CONTIGO)

Purpose: To compare a culturally targeted video and a Spanish-language fact sheet for enhancing genetic counseling, increasing genetic testing, and improving psychosocial outcomes.

Who is this for?: Latina women with stage 0 (DCIS), stage I, stage II, stage III, or stage IV (metastatic) breast cancer or healthy women with a family history of cancer that suggests hereditary breast and ovarian cancer who speak Spanish. You must not have received genetic counseling or testing. 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">Watch the video: <q>Is My Cancer Hereditary? Rosa Visits a Genetic Counselor,</q> virtual</li> <li class="seamTextUnorderedListItem">Surveys, 3 times within 4 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Read a fact sheet, virtual</li> <li class="seamTextUnorderedListItem">Surveys, 3 times within 4 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The culturally targeted video is in Spanish with English subtitles. It provides education about genetic counseling and testing and hereditary breast and ovarian cancer to at-risk Latinas.</li> <li class="seamTextUnorderedListItem">The fact sheet includes information about genes, breast cancer, risk factors for hereditary breast and ovarian cancer, genetic counseling and testing, and resources.</li> <li class="seamTextUnorderedListItem">All participants will be offered genetic counseling and 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/NCT05130606' target='_blank'>ClinicalTrials.gov</a> </li></ul>
18

Video Versus Fact Sheet to Increase Genetic Counseling and Testing for Latina Women With Stage 0-IV Breast Cancer or High-Risk Women

Testing a Narrative Intervention to Enhance Genetic Counseling and Testing (CONTIGO)
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Nearest Location:
2430 miles
Virginia Commonwealth University
Richmond, VA

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Visits:
3 visits within 4 months

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ClinicalTrials.gov: NCT05130606

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Phase NA

19

Set of Rules (Algorithm) to Find Therapeutic Options for Triple Negative or HR+, HER2- Metastatic Breast Cancer

An Exploratory Study Using a Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)

Purpose: To study whether a set of rules (an algorithm) called ENLIGHT can help choose approved drugs that will treat aggressive breast cancers more effectively.

Who is this for?: People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. You must have received at least one line of therapy, be planning to stop your current therapy due to progression of your cancer or side effects, and be not eligible for another treatment. If HR+, your cancer must be resistant to hormone therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor analyzed by ENLIGHT, TruSight(R) Oncology 500, and TruSeq</li> <li class="seamTextUnorderedListItem">No therapy match, treatment selected by doctor</li> <li class="seamTextUnorderedListItem">Blood samples</li> <li class="seamTextUnorderedListItem">Biopsy after treatment (optional)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor analyzed by ENLIGHT, TruSight(R) Oncology 500, and TruSeq</li> <li class="seamTextUnorderedListItem">Treatment with matched, approved drug for participant's cancer, given by participant's doctor</li> <li class="seamTextUnorderedListItem">Blood samples</li> <li class="seamTextUnorderedListItem">Biopsy after treatment (optional)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor analyzed by ENLIGHT, TruSight(R) Oncology 500, and TruSeq</li> <li class="seamTextUnorderedListItem">Treatment with matched drug approved for another use, given by doctors at NIH</li> <li class="seamTextUnorderedListItem">Blood samples</li> <li class="seamTextUnorderedListItem">Biopsy after treatment (optional)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized medicine currently selects only a small subgroup of patients by looking for direct matches between their cancer and treatments. This trial is testing a way of identifying more patients who may benefit from targeted therapies.</li> <li class="seamTextUnorderedListItem">ENLIGHT analyzes tumor tissue and may be useful for identifying therapeutic options for people with metastatic breast cancer who currently have limited treatment options.</li> <li class="seamTextUnorderedListItem">The TruSight and TruSeq tests look for biomarkers in tumor tissue and blood that match a person to an approved 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/NCT07067138' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/new-biomarkers/' target='_blank'>Metastatic Trial Talk: Biomarkers to Select Treatments for MBC</a> </li></ul>
19

Set of Rules (Algorithm) to Find Therapeutic Options for Triple Negative or HR+, HER2- Metastatic Breast Cancer

An Exploratory Study Using a Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)
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Nearest Location:
2432 miles
National Institutes of Health Clinical Center
Bethesda, MD

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT07067138

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Phase NA

20

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>
20

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

21

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>
21

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

22

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>
22

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

23

Studying the Relationship Between Inherited KRAS Mutations and Breast Cancer Risk

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

Purpose: To study the relationship between the KRAS mutation and cancer risk.

Who is this for?: People with stage I, stage II, stage III, and stage IV (metastatic) breast cancer, or people with a family history of breast cancer. You must also have endometriosis or an autoimmune condition. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Saliva sample to test for the KRAS mutation</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">An inherited KRAS genetic mutation 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">Participants will be able to get their KRAS mutation test results after submitting their sample at a discounted cost ($295).</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/NCT02253251' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://miradx.com/test/kras-variant/' target='_blank'>MiraKind Research Company: KRAS-Variant</a> </li><li class='seamTextUnorderedListItem'><a href='http://mirakind.org/study-eligibility-questionnaire/' target='_blank'>Research Company: Eligibility Survey</a> </li></ul>
23

Studying the Relationship Between Inherited KRAS Mutations 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:
No visits required

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ClinicalTrials.gov: NCT02253251

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Phase NA

24

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>
24

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

25

Saliva Samples and Questionnaires to Study How Genes Affect Breast Cancer Risk

The Rutgers University Genetics Coordinating Center Breast Cancer Study

Purpose: To study how genes impact breast cancer risk.

Who is this for?: People with stage 0 (DCIS), stage I, stage II, stage III, or stage IV (metastatic) breast cancer, and people who have not been diagnosed with breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Provide saliva (spit) sample, by mail</li> <li class="seamTextUnorderedListItem">Questionnaires, online</li> <li class="seamTextUnorderedListItem">Access to your health records (optional)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">By participating in this study, you will receive information about your genetic risk for free.</li> <li class="seamTextUnorderedListItem">Mutations in genes called BRCA1 and BRCA2 explain only about 25% of the genetic cause of breast cancer. </li> <li class="seamTextUnorderedListItem">Researchers are trying to learn more about the genetic cause of breast cancer, which will help researchers create new treatments and improve current treatment options.</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/NCT06773897' target='_blank'>ClinicalTrials.gov</a> </li></ul>
25

Saliva Samples and Questionnaires to Study How Genes Affect Breast Cancer Risk

The Rutgers University Genetics Coordinating Center Breast Cancer Study
No Travel Required
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Visits:
No visits required

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ClinicalTrials.gov: NCT06773897

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Phase NA

26

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>
26

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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