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1

Supportive Cancer Care Delivered Virtually or by a Health Worker for Stage 0-IV Breast Cancer

Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer

Purpose: To compare a technology-based supportive cancer care approach with a team-based supportive cancer care approach.

Who is this for?: People with stage 0 (DCIS), stage I, stage II, stage III, or stage IV breast cancer that is newly diagnosed or whose cancer has come back. 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</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Educational materials, virtual, weekly for 4 months, then every 2 weeks for 8 months</li> <li class="seamTextUnorderedListItem">Questionnaires, every 3 months for 1 year</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Educational materials, in person or by phone, weekly for 4 months, then every 2 weeks for 8 months</li> <li class="seamTextUnorderedListItem">Questionnaires, every 3 months for 1 year</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The educational materials are designed to assist with advance care planning and symptom management. Topics include surrogate decision-makers, advance directives, and physician orders for life-sustaining treatment. The education is delivered to the participant by an electronic health record message or email, or by a lay health worker. </li> <li class="seamTextUnorderedListItem">This trial is 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/NCT05297734' target='_blank'>ClinicalTrials.gov</a> </li></ul>
1

Supportive Cancer Care Delivered Virtually or by a Health Worker for Stage 0-IV Breast Cancer

Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer
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Nearest Location:
2 miles
Zuckerberg San Francisco General
San Francisco, CA

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Visits:
Up to 2 to 4 times per month for 1 year

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ClinicalTrials.gov: NCT05297734

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Phase NA

2

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>
2

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

3

Radiation to Delay Treatment Changes and CTCs to Guide Treatment Options for People with Metastatic Breast Cancer

Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy (BOSS)

Purpose: To study if radiation therapy can delay treatment changes and if circulating tumor cells (CTCs) can help guide treatment options.

Who is this for?: Women with stage IV (metastatic) breast cancer who have been receiving their first line of therapy for metastatic disease for at least 1 year or have been receiving their second or later line of therapy for at least 6 months. You must have 1-3 sites of oligoprogressive disease that have not received radiation and must not have triple negative 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 tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (also called stereotactic radiosurgery or stereotactic body radiotherapy) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Circulating tumor cells (CTCs) are cancer cells from a tumor that circulate in the bloodstream.</li> <li class="seamTextUnorderedListItem">In this trial, CTCs may be used to help you and your doctor guide treatment options.</li> <li class="seamTextUnorderedListItem">Oligoprogressive disease refers to progression of only a few sites of metastasis.</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/NCT06055881' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/clinical-trials/cls-20555625' target='_blank'>Mayo Clinic: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/sbrt/pyc-20446794' target='_blank'>Mayo Clinic: Stereotactic Body Radiotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/20071218' target='_blank'>Breastcancer.org: Circulating Tumor Cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/ctc/' target='_blank'>Metastatic Trial Talk: Circulating Tumor Cell Testing</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oligometastatic-breast-cancer/' target='_blank'>Metastatic Trial Talk: What is Oligometastatic Breast Cancer?</a> </li></ul>
3

Radiation to Delay Treatment Changes and CTCs to Guide Treatment Options for People with Metastatic Breast Cancer

Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy (BOSS)
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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: NCT06055881

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Phase NA

4

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

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

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

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

What's involved?

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

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is an anti-estrogen therapy used to treat hormone-sensitive breast cancer.</li> <li class="seamTextUnorderedListItem">ESR1 mutations in breast cancer may affect how well tamoxifen works against tumor cells. </li> <li class="seamTextUnorderedListItem">Tracers are chemicals that are used to find cancer cells in the body during a PET scan. The imaging trial will use the tracer fluoroestradiol (FES)--it finds estrogen receptors in breast tumors. </li> <li class="seamTextUnorderedListItem">The FES tracer may also show how tamoxifen is affecting your tumors. Researchers may use this information to increase your dose of tamoxifen.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ESR1</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04174352' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/research-and-advocacy/asco-care-and-treatment-recommendations-patients/hormonal-therapy-metastatic-breast-cancer' target='_blank'>ASCO Cancer.net: Hormonal Therapy for Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal/serms/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/more-effective-therapies-needed-for-patients-with-esr1mutated-breast-cancer' target='_blank'>Targeted Oncology: More Effective Therapies Needed For Patients With ESR1-Mutated Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.karger.com/Article/FullText/481428' target='_blank'>Journal Article: Are We Ready to Use ESR1 Mutations in Clinical Practice</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ijcem.com/files/ijcem0076055.pdf' target='_blank'>Journal Article: The Role of PET Imaging Probes for Early Monitoring the Response to Tamoxifen</a> </li></ul>
4

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

A Pilot Study of FES Imaging to Optimize Tamoxifen Dose for Metastatic Breast Cancer Patients With ESR1 Mutations
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Nearest Location:
1678 miles
University of Wisconsin Carbone Cancer Center
Madison, WI

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Visits:
1 visit every 3 to 4 weeks, ongoing

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ClinicalTrials.gov: NCT04174352

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Phase I

5

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>
5

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

6

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>
6

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

7

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>
7

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

8

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>
8

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

9

Studying Response to Treatment With CDK 4/6 Inhibitors in People with Stage I-IV HR+, HER2- Breast Cancer

The Roswell Park Ciclib Study: A Prospective Study of Biomarkers and Clinical Features of Advanced/Metastatic Breast Cancer Treated With CDK4/6 Inhibitors

Purpose: To study how breast cancer develops resistance to treatment with CDK 4/6 inhibitors and how to predict response to treatment with CDK 4/6 inhibitors.

Who is this for?: People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer or people with stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) node positive breast cancer. You must have completed treatment with or currently be receiving treatment with a CDK 4/6 inhibitor. View full eligibility criteria

What's involved?

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

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your samples may be used to help your doctor make treatment decisions.</li> <li class="seamTextUnorderedListItem">Node positive breast cancer is breast cancer that has spread to the lymph nodes.</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.</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/NCT04526587' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK 4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/?utm_medium=email&utm_source=subscribers&utm_campaign=Dec2022&utm_content=Email122022' target='_blank'>Metastatic Trial Search: CDK Inhibitors</a> </li></ul>
9

Studying Response to Treatment With CDK 4/6 Inhibitors in People with Stage I-IV HR+, HER2- Breast Cancer

The Roswell Park Ciclib Study: A Prospective Study of Biomarkers and Clinical Features of Advanced/Metastatic Breast Cancer Treated With CDK4/6 Inhibitors
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Nearest Location:
2299 miles
Roswell Park Cancer Institute
Buffalo, NY

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04526587

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Phase NA

10

Studying Tumor Blood Flow to Make Treatment Decisions for People with Stage 0-IV Breast Cancer

Intravital Microscopy (IVM) in Human Solid Tumors

Purpose: To use Human Intravital Microscopy (HIVM) to study tumor blood flow and gather information to make treatment decisions.

Who is this for?: People with stage 0 (DCIS), stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive surgery. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Human Intravital Microscopy (HIVM) with fluorescein, by IV, during surgery</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Human Intravital Microscopy (HIVM) is a procedure completed during surgery to study tumor blood vessels and blood flow.</li> <li class="seamTextUnorderedListItem">IVM can determine if your blood vessels work well enough to be able to receive some types of cancer treatment.</li> <li class="seamTextUnorderedListItem">Fluorescein is used during HIVM to see how blood flows.</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/NCT03823144' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/what-is-cancer/body-systems-and-cancer/cancer-the-blood-and-circulation' target='_blank'>Cancer Research UK: Cancer and Blood Circulation</a> </li></ul>
10

Studying Tumor Blood Flow to Make Treatment Decisions for People with Stage 0-IV Breast Cancer

Intravital Microscopy (IVM) in Human Solid Tumors
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Nearest Location:
2383 miles
Mayo Clinic Florida
Jacksonville, FL

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Visits:
Coincides with surgery

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ClinicalTrials.gov: NCT03823144

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Phase NA

11

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>
11

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

12

Dose Selection of Capecitabine or 5-Fluorouracil According to Genetic Testing for the DYPD Gene for Stage I-IV Breast Cancer

DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

Purpose: To study the safety and effects (good and bad) of 5-fluorouracil (5-FU) or capecitabine (Xeloda®) chemotherapy when the dose is selected based on testing of the DPYD gene.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive 5-fluorouracil (5-FU) or capecitabine (Xeloda®). You must have received DPYD genetic testing. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups, depending on your DPYD genetic testing results: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Normal DPYD Gene</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">5-fluorouracil (5-FU), by injection, standard dose OR </li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by injection, standard dose</li> <li class="seamTextUnorderedListItem">Dose will be reduced if needed</li> <li class="seamTextUnorderedListItem">Dose may be increased if tolerated</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: DPYD Gene Variant</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">5-fluorouracil (5-FU), by injection, half the standard dose OR </li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by injection, half the standard dose</li> <li class="seamTextUnorderedListItem">Dose may be increased if tolerated</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">5-Fluorouracil (5-FU) and capecitabine (Xeloda®) are chemotherapy drugs commonly used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">People can respond differently to these drugs due to genetic variations. The FDA now recommends testing for these genetic variants.</li> <li class="seamTextUnorderedListItem">This trial will test dosing of these drugs guided by 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/NCT07158164' target='_blank'>ClinicalTrials.gov</a> </li></ul>
12

Dose Selection of Capecitabine or 5-Fluorouracil According to Genetic Testing for the DYPD Gene for Stage I-IV Breast Cancer

DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
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Nearest Location:
2541 miles
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, NJ

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT07158164

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Phase IV

13

Multi-Disciplinary Care and Decision Making for People with Brain Metastases

Intensive Multi-Disciplinary Care Initiative for Patients With Newly Diagnosed Brain Metastases

Purpose: To compare how well multi-disciplinary care and standard care work for managing symptoms and understanding outcomes.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). Your brain metastases must be newly diagnosed. 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: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Usual care</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Multi-disciplinary care</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Care for people with brain metastases involves complex medical decision making and requires input for multiple groups (disciplines).</li> <li class="seamTextUnorderedListItem">Multi-disciplinary care includes medical oncology, neurosurgery, radiation oncology, neuro-oncology, and palliative care.</li> <li class="seamTextUnorderedListItem">This process may look different for different patients.</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/NCT06280300' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
13

Multi-Disciplinary Care and Decision Making for People with Brain Metastases

Intensive Multi-Disciplinary Care Initiative for Patients With Newly Diagnosed Brain Metastases
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Nearest Location:
2564 miles
University of Vermont Medical Center
Burlington, VT

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06280300

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Phase NA

14

Clinical Trial Education and Navigation for People with Stage I-IV Breast Cancer

Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials

Purpose: To study whether a list of clinical trials, clinical trial educational materials, and clinical trial patient navigators (CTPN) increase participation in clinical trials, especially in the Black, Indigenous, and People of Color (BIPOC) community.

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">List of matched clinical trials</li> <li class="seamTextUnorderedListItem">Clinical trial educational materials</li> <li class="seamTextUnorderedListItem">Clinical trial patient navigator (CTPN)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive a list of matched clinical trials and educational materials designed to inform and empower you to consider clinical trials.</li> <li class="seamTextUnorderedListItem">You will also work with a clinical trial patient navigator (CTPN) to further educate you about clinical trials.</li> <li class="seamTextUnorderedListItem">This trial is available in English and Spanish.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types 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/NCT05146297' target='_blank'>ClinicalTrials.gov</a> </li></ul>
14

Clinical Trial Education and Navigation for People with Stage I-IV Breast Cancer

Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials
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Nearest Location:
2569 miles
Herbert Irving Comprehensive Cancer Care Center
New York, NY

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05146297

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Phase NA

15

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>
15

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

16

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>
16

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

17

Using Artificial Intelligence to Match Patients to Clinical Trials (SYNERGY-AI)

SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry

Purpose: To study if a computer that has been taught how to match people to clinical trials (artificial intelligence) can help increase enrollment in clinical trials.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have already decided to enroll in a clinical trial. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A clinical trial matching report based on your medical records that you can review with your doctor.</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial will use artificial intelligence and virtual tumor boards to help match people to clinical trials.</li> <li class="seamTextUnorderedListItem">The researchers will also create a registry to study the medical and financial effects of this program. </li> <li class="seamTextUnorderedListItem">This is an international trial that 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/NCT03452774' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://massivebio.com/' target='_blank'>Massive Bio Study Information Page</a> </li></ul>
17

Using Artificial Intelligence to Match Patients to Clinical Trials (SYNERGY-AI)

SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
No Travel Required
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Visits:
No visits required

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ClinicalTrials.gov: NCT03452774

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Phase NA

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