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1

Choosing Targeted Therapy Based on a Tumor's Genetic Makeup for Advanced Breast Cancer (TAPUR)

A Basket Study: Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of using a tumor's genetic profile to select an FDA-approved targeted therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with no standard treatment options. You must have results from a <span class="highlight">genomic</span> or immunohistochemistry test approved by TAPUR. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive an FDA-approved targeted therapy based on your tumor's genetic profile.</p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The targeted therapy you receive will be selected based on your tumor's genetic profile.</li> <li class="seamTextUnorderedListItem">Your treatment may include one or more of the following: Abemaciclib, Futibatinib, Nivolumab, Ipilimumab, Olaparib, Palbociclib, Pembrolizumab, Regorafenib, Sunitinib, Talazoparib, Temsirolimus, Trastuzumab, Pertuzumab, Vemurafenib, Cobimetinib</li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket trials enroll people based on the kind of mutations found in their tumors.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ALK, ATM, BRAF, BRAF V600E/D/K/R, BRCA1/2, CDK4, CDK6, CDKN2A, CSF1R, FGFR1/2/3/4, HER2 (ERBB2), high mutational load and others, KIT, MET, MSI-H, mTOR, NRG1, PALB2, PDGFR, POLD1, POLE, RAF-1, RET, ROS1, TSC, VEGFR</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/NCT02693535' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.tapur.org/' target='_blank'>ASCO: TAPUR Study Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/research-and-advocacy/clinical-trials/what-tapur-study' target='_blank'>Cancer.Net (Video): What is the TAPUR Study?</a> </li><li class='seamTextUnorderedListItem'><a href='https://old-prod.asco.org/research-data/tapur-study/study-participation' target='_blank'>ASCO: TAPUR Study Participation</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.onclive.com/conference-coverage/asco-2016/dr-edward-kim-on-ascos-tapur-trial' target='_blank'>OncLive (Video): About TAPUR</a> </li></ul>
1

Choosing Targeted Therapy Based on a Tumor's Genetic Makeup for Advanced Breast Cancer (TAPUR)

A Basket Study: Targeted Agent and Profiling Utilization Registry (TAPUR) Study
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Nearest Location:
3 miles
Kaiser Permanente - San Francisco Medical Center
San Francisco, CA

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Visits:
Coincides with targeted therapy

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ClinicalTrials.gov: NCT02693535

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Phase II

2

<span class="highlight">Genomic</span> Test Studying the Tumor Microenvironment for Advanced Breast Cancer

BostonGene and Exigent <span class="highlight">Genomic</span> 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

<span class="highlight">Genomic</span> Test Studying the Tumor Microenvironment for Advanced Breast Cancer

BostonGene and Exigent <span class="highlight">Genomic</span> 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

Genetic Testing for Choosing a Targeted Therapy for Brain Metastases that Test Positive for Certain Mutations

<span class="highlight">Genomically-Guided</span> Treatment Trial in Brain Metastases

Purpose: To study the anti-cancer activity of choosing a targeted therapy for brain metastases based on the genetic mutations found in your tumors.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread (metastasized) to your brain with a gene mutation or alteration in: NTRK, ROS1, CDK or PI3K. You must have already received at least one treatment for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 3 groups depending on which genetic mutations are found in your tumors: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: CDK-mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: PI3K-mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-0084, by mouth, daily, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: NTRK or ROS1-mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Entrectinib (Rozlytrek®), by mouth, daily, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor samples from your brain and other parts of your body will be tested for mutations. This is called <span class="highlight">genomic</span> testing.</li> <li class="seamTextUnorderedListItem">You will be assigned a targeted therapy based on which genetic mutations are found in your tumors.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer. </li> <li class="seamTextUnorderedListItem">Targets or mutations: NTRK, ROS1, CDK, PI3K</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/NCT03994796' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/brain-mets/' target='_blank'>Metastatic Breast Cancer Network: Brain Mets</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verzenio.com/hcp/patient-profiles' target='_blank'>Eli Lilly & Company Drug Information Page: Verzenio® (Abemaciclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.rozlytrek.com' target='_blank'>Genentech USA Drug Information Page: Rozlytrek (Entrectinib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/pi3k-inhibitor-gdc-0084' target='_blank'>NCI Drug Dictionary: GDC-0084</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/targeting-sanctuary-site-options-when-breast-cancer-metastasizes-brain' target='_blank'>Journal Article: Targeting the Sanctuary Site, Options when Breast Cancer Metastasizes to the Brain</a> </li></ul>
3

Genetic Testing for Choosing a Targeted Therapy for Brain Metastases that Test Positive for Certain Mutations

<span class="highlight">Genomically-Guided</span> Treatment Trial in Brain Metastases
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Nearest Location:
374 miles
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT03994796

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Phase II

4

Ribociclib and Belinostat for Advanced Triple Negative Breast Cancer

A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By <span class="highlight">Genomics</span> (CHARGE)

Purpose: To study the safety, dose, side effects and anti-cancer activity of giving the CDK 4/6 inhibitor ribociclib (Kisqali®) in combination with the chemotherapy belinostat (Beleodaq®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not already received a CDK 4/6 inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Belinostat (Beleodaq®), by IV, 5 days in a row (1 week on, 3 weeks off), ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor--it blocks two enzymes, CDK4 and CDK6, that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Ribociclib is approved for use in combination with an aromatase inhibitor to treat postmenopausal women with advanced hormone positive, HER2 negative breast cancer--but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Belinostat (Beleodaq®) is a type of chemotherapy called an histone deacetylase (HDAC) inhibitor. It is approved for use in some other types of cancer, but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced 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/NCT04315233' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/belinostat.aspx' target='_blank'>Chemocare.com: Belinostat (Beleodaq®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617008.html' target='_blank'>MedLinePlus: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/cdk4-6-inhibitors-make-headway-in-her2-and-triple-negative-breast-cancers' target='_blank'>OncLive: CDK4/6 Inhibitors Make Headway in HER2+ and Triple-Negative Breast Cancers</a> </li></ul>
4

Ribociclib and Belinostat for Advanced Triple Negative Breast Cancer

A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By <span class="highlight">Genomics</span> (CHARGE)
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Nearest Location:
602 miles
Huntsman Cancer Institute
Salt Lake City, UT

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Visits:
5 visits a month, ongoing

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ClinicalTrials.gov: NCT04315233

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Phase I

5

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 <span class="highlight">genomic</span> 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>
5

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

6

HARMONY: Using a <span class="highlight">Genomic</span> Test to Guide Treatment Decisions for Metastatic Breast Cancer

HARMONY: Harnessing the Analysis of RNA Expression and Molecular Subtype to Optimize Novel TherapY for Metastatic Breast Cancer

Purpose: To study if <span class="highlight">genomic</span> testing affects which line of therapy doctors suggest people with metastatic breast cancer receive.

Who is this for?: People with metastatic (stage IV) breast cancer who have received no more than one line of therapy for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PAM50 (Prosigna®) testing of your breast tumor, 1 time</li> <li class="seamTextUnorderedListItem">Results of the PAM50 test will be given to your treating doctor</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The standard of care for treating metastatic breast cancer is to make treatment decisions based on clinical subtype. </li> <li class="seamTextUnorderedListItem">Clinical subtypes include hormone-positive (ER+ and/or PR+), HER2-positive (HER2+), and triple-negative (ER-, PR-, HER2-).</li> <li class="seamTextUnorderedListItem">The PAM50 (Prosigna®) is a <span class="highlight">genomic</span> test approved for use in some women with early-stage breast cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Genomic testing looks at genetic mutations within your tumor. This gives your doctor a genetic subtype of your tumor. </li> <li class="seamTextUnorderedListItem">This trial is studying whether knowing a tumor's genetic subtype will affect how doctors treat people with metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">Making treatment decisions based on genetic subtypes is not the standard of care.</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/NCT03769415' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://unclineberger.org/octr/our-team/' target='_blank'>Study Coordinator Information: Terri Eubanks</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/inside-clinical-trials/genomic-tumor-testing/' target='_blank'>Metastatic Trial Talk: Genomic Testing</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prosigna.com' target='_blank'>Veracyte Test Information Page: PAM50 (Prosigna®)</a> </li></ul>
6

HARMONY: Using a <span class="highlight">Genomic</span> Test to Guide Treatment Decisions for Metastatic Breast Cancer

HARMONY: Harnessing the Analysis of RNA Expression and Molecular Subtype to Optimize Novel TherapY for Metastatic Breast Cancer
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Nearest Location:
2402 miles
UNC Rex Healthcare
Raleigh, NC

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Visits:
1 visit

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ClinicalTrials.gov: NCT03769415

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Phase NA

7

Analyzing Tumor Mutations Before and After Treatment with Targeted Therapies

A Basket Study: Tumor <span class="highlight">Genomic</span> Profiling in Patients Evaluated for Targeted Cancer Therapy

Purpose: To compare genetic mutations seen in a tumor sample before and after treatment with a targeted therapy. The study will investigate how tumor mutations can be used to predict a cancer's response to treatment and how they change in response to targeted therapies.

Who is this for?: People who are receiving ongoing care at Memorial Sloan Kettering Cancer Center. View full eligibility criteria

What's involved?

<p class="seamTextPara"> All participants will be asked to provide: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A tube of blood</li> <li class="seamTextUnorderedListItem">Cheek swab (also known as a buccal), or a saliva sample that contains normal genes for comparison</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Leftover tumor tissue from a previous surgery or biopsy will be used for <span class="highlight">genomic</span> testing.</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Most genetic mutations found in cancer cells are not passed down from parents (inherited), but occur when the cells make mistakes when they divide.</li> <li class="seamTextUnorderedListItem">Most cancers have many mutations.</li> <li class="seamTextUnorderedListItem">Some of these mutations help drive the tumor's growth, while others are just bystanders.</li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket trials enroll people based on the kind of mutations found in their tumors.</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/NCT01775072' target='_blank'>ClinicalTrials.gov</a> </li></ul>
7

Analyzing Tumor Mutations Before and After Treatment with Targeted Therapies

A Basket Study: Tumor <span class="highlight">Genomic</span> Profiling in Patients Evaluated for Targeted Cancer Therapy
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Nearest Location:
2494 miles
Lehigh Valley Health Network
Allentown, PA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT01775072

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Phase NA

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