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(Last updated: May 21, 2020)

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1

NEAREST SITE: 3 miles
Sutter Cancer Research Consortium
San Francisco,CA

VISITS: Coincides with targeted therapy

PHASE: II

NCT ID: NCT02693535

Treating Advanced Cancer By Choosing Targeted Therapy Based on Tumor's Genetic Makeup (TAPUR)

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

Purpose
To evaluate the safety and effects (good and bad) of using a tumor's genetic alterations to select an FDA-approved targeted therapy for treatment.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer for whom there is no currently available therapy. You must have results from a genomic or immunohistochemistry test approved by TAPUR.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> Participants will receive an FDA-approved targeted therapy that is chosen based on the tumor's genetic makeup.</p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The targeted therapy each patient receives will be selected based on their tumor's specific genetic profile.</li> <li class="seamTextUnorderedListItem">Your treatment may include one or more of the following: Abemaciclib, Afatinib, Crizotinib, Nivolumab, Ipilimumab, Olaparib, Palbociclib, Pembrolizumab, Regorafenib, Sunitinib, Talazoparib, Temsirolimus, Trastuzumab, Pertuzumab, Vemurafenib, Cobimetinib</li> <li class="seamTextUnorderedListItem">Targets or mutations: ALK, ATM, BRAF, BRAF V600E/D/K/R, BRCA1/2, CDK4, CDK6, CDKN2A, CSF1R, ERBB2, high mutational load and others, KIT, MET, MSI-H, mTOR, NRG1, PALB2, PDGFR, POLD1, POLE, RAF-1, RET, ROS1, TSC, VEGFR.</li></ul>
  • <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: Study website</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: About TAPUR (video)</a> </li></ul>
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2

NEAREST SITE: 341 miles
Cedars-Sinai Medical Center
Los Angeles,CA

VISITS: Coincides with type of therapy

PHASE: NA

NCT ID: NCT03098576

Genetic Tumor Profiling to Select Targeted Drug to Treat Advanced Breast Cancer

A Basket Study: Personalized Cancer Care at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute Scientific Title

Purpose
To determine which targeted drug could be used as a treatment for your cancer.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have had at least one treatment your tumor did not respond to or progressed on.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups based on the results of your molecular profiling: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Matched targeted drug treatment</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive a drug that is targeted to a specific genetic abnormality (mutation) if a mutation is found</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive the standard of care therapy if no mutation is found</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Molecular profiling is a process that identifies mutations and biomarkers in your tumor's DNA that have FDA-approved matched therapies or are eligible for clinical studies.</li> <li class="seamTextUnorderedListItem">In this study, a sample of your tumor will be analyzed (called molecular profiling) at Cedars-Sinai Medical Center in California.</li> <li class="seamTextUnorderedListItem">Targets or mutations: varies based on your test results</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03098576' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancercenter.com/treatments/tumor-molecular-profiling/' target='_blank'>Cancer Treatment Center of America: Tumor Molecular Profiling</a> </li></ul>
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3

NEAREST SITE: 660 miles
Mayo Clinic in Arizona
Scottsdale,AZ

VISITS: At least 2 visits

PHASE: NA

NCT ID: NCT03281902

Genetic Analysis of Blood & Tumor Samples in Advanced HR+, HER2- Breast Cancer (PROMISE)

Prospective Study to Evaluate the Role of Tumor Sequencing in Women Receiving Palbociclib for Advanced Hormone Receptor (HR)-Positive, Breast Cancer (PROMISE) Scientific Title

Purpose
To see whether genetic information obtained from your tumor and blood can help doctors personalize cancer treatments.
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer planning on being treated with palbociclib (Ibrance®) and an anti-estrogen therapy.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood collection, before treatment and on day 1 of each treatment cycle</li> <li class="seamTextUnorderedListItem">Biopsies, prior to the beginning of treatment and after 2 months of treatment</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This study is investigating whether genetic information obtained from your tumor and blood can help doctors personalize cancer treatments.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03281902' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/pmts/mc7000-mc7099/mc7024-103.pdf' target='_blank'>Mayo Clinic: PROMISE Trial Sept. 2019 Newsletter</a> </li><li class='seamTextUnorderedListItem'><a href='http://mayoresearch.mayo.edu/center-for-individualized-medicine/breast-cancer-study.asp' target='_blank'>Mayo Clinic: Study website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.youtube.com/watch?v=onKf2JLXQxE&feature=youtu.be' target='_blank'>PROMISE Breast Cancer Clinical Trial (video)</a> </li></ul>
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4

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT02152254

Molecular Profiling-Based Targeted Therapies for Metastatic Breast (and Other) Cancer (Basket Study)

A Basket Study: Randomized Study Evaluating Molecular Profiling and Targeted Agents in Metastatic Cancer: Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT 2) Scientific Title

Purpose
To see if choosing metastatic breast (or other types of) cancer treatment based on the tumor's molecular profile is more effective than the current standard of care.
Who is this for?
People with metastatic (stage IV) breast cancer who have been treated with standard of care therapy.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> All participants will have their tumor biopsy undergo molecular profiling. Participants who have tumors with no molecular abnormality will receive an FDA-approved therapy. Participants with a molecular abnormality will then 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">Targeted therapy based on molecular profiling</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physican's choice standard of care</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Patients whose tumors progress will have the option of crossing over to the other treatment arm</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Molecular profiling of a tumor may identify genetic mutations or biomarkers that suggest the tumor is likely to respond to a currently available targeted therapy. </li> <li class="seamTextUnorderedListItem">It is not known if choosing metastatic breast (or other types of) cancer treatment based on the tumor's molecular profile is more effective than the current standard of care. </li> <li class="seamTextUnorderedListItem">All patients who enroll in this study will have molecular profiling performed on a biopsy of their tumor. </li> <li class="seamTextUnorderedListItem">If there is no mutation or biomarker found, the patient will receive the treatment their doctor determines is the best option. </li> <li class="seamTextUnorderedListItem">If a mutation or biomarker is found and there is an FDA-approved drug for the tumor type, patients will be offered that treatment. </li> <li class="seamTextUnorderedListItem">If there is a mutation or biomarker found but no FDA-approved drug that targets it, patients will be randomly assigned to either a targeted therapy or the standard of care.</li> <li class="seamTextUnorderedListItem">Targets or mutations: vary based on test results.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02152254' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02152254?term=NCT02152254&rank=1' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/research-news/20130816' target='_blank'>BreastCancer.org: Molecular Profiling Pilot Study</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/publications/oncolog/january-2015/impact2-study-tests-benefits-of-personalized-cancer-treatment-ba.html' target='_blank'>MD Anderson: article</a> </li></ul>
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5

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: 1 visit

PHASE: NA

NCT ID: NCT02918474

A Tool to Help Women Decide Whether to Have a Contralateral Preventative Mastectomy

Decision Making Tool for Contralateral Prophylactic Mastectomy Scientific Title

Purpose
To learn more about an online decision support tool that helps you and your doctor discuss whether or not you should have a contralateral prophylactic mastectomy (removal of breast that does not have cancer).
Who is this for?
Women recently diagnosed with DCIS or stage I, stage II, or stage III breast cancer and are seeing a surgeon at MD Anderson Cancer Center.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will complete a questionnaire before and after using the decision support tool.</p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">If you take part in this study, you will complete a questionnaire about the decision support tool.</li> </ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02918474' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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6

NEAREST SITE: 2246 miles
Virginia K Crosson Cancer Center
Fullerton,CA

VISITS: 1 to 4 appointments (by phone or in person) a month, for 1 year

PHASE: NA

NCT ID: NCT03154190

Supportive Care for People With Metastatic Breast Cancer

St. Judes-Stanford Comprehensive Support Initiative Scientific Title

Purpose
To learn whether supportive care from a health care coach is better than standard support for helping you make treatment decisions that include concerns about symptom management.
Who is this for?
People with newly diagnosed metastatic (stage IV) breast cancer.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Health Care Coach Support</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sessions with a health care coach, by phone or in person, 1 at baseline and 1 after first oncology appointment</li> <li class="seamTextUnorderedListItem">Sessions with a health care coach, by phone or in person, weekly or monthly (based on need), for 1 year</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care Support</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care support</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Health care coaches are trained to talk to and educate cancer patients and their family members about care goals and shared decision making.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of metastatic cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03154190' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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7

NEAREST SITE: 2453 miles
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore,MD

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT02965755

Liquid Biopsy for Molecular Profiling for Treating Metastatic Breast Cancer

Individualized Molecular Analyses Guide Efforts in Breast Cancer - Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins Scientific Title

Purpose
To determine whether a liquid biopsy (blood test) can identify molecular or genetic factors that can help doctors make personalized treatment recommendations.
Who is this for?
People being treated for metastatic (stage IV) breast cancer who have already received chemotherapy.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> This study consists of the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genetic profiling (blood draws, review of tumor tissue)</li> <li class="seamTextUnorderedListItem">Possible treatment recommendations based on genetic profiling results</li></ul>
  • <p class="seamTextPara"> The information obtained from the liquid biopsy may help guide recommendations for your next treatment.</p>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02965755' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/KomenPerspectives/Tumor-profiling-%E2%80%93-personalizing-treatment-for-breast-cancer.html' target='_blank'>Komen: Tumor Profiling-Personalizing Treatment for Breast Cancer</a> </li></ul>
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8

NEAREST SITE: 2569 miles
Columbia University Medical Center
New York,NY

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT03069742

Web-based Decision Aids for High-Risk Women

Web-based Decision Aids for Breast Cancer Risk Assessment and Increasing Breast Cancer Chemoprevention in the Primary Care Setting: Randomized Controlled Trial Scientific Title

Purpose
To evaluate how well the RealRisks decision aid helps you to understand your breast cancer risk and your risk reduction options as well as develop an action plan with your provider.
Who is this for?
Women who are at high risk for breast cancer and receiving primary care at Columbia University Medical Center/ New York-Presbyterian Hospital.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <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">RealRisks web-based decision aid tool</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard health education brochures</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RealRisks is a web-based decision aid for patients that is designed to work with the Breast Cancer Risk Navigation tool developed for doctors.</li> </ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03069742' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://realrisks.dbmi.columbia.edu/' target='_blank'>RealRisks Website</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.facingourrisk.org/understanding-brca-and-hboc/information/risk-management/chemoprevention-breast-cancer/basics/overview.php' target='_blank'>Chemoprevention</a> </li></ul>
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9

NEAREST SITE: 2693 miles
Beth Israel Deaconess Medical Center
Boston,MA

VISITS: 3 visits

PHASE: NA

NCT ID: NCT02823262

Decision Aid for Women Age 70 and Older Diagnosed with ER+, HER2- Stage I-II Breast Cancer

A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older Scientific Title

Purpose
To evaluate a breast cancer treatment Decision Aid created specifically for newly diagnosed older women.
Who is this for?
Women 70 or older who have been diagnosed with estrogen receptor positive (ER+), HER2 negative breast cancer. Your tumor must be either stage I or stage II.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Decision Aid</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Initial surgical consultation</li> <li class="seamTextUnorderedListItem">Treatment decision assistance provided by the Decision Aid</li> <li class="seamTextUnorderedListItem">Assessments, at 1 week and 5 months after surgical consultation</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Initial surgical consultation</li> <li class="seamTextUnorderedListItem">Usual care assistance when making treatment decisions</li> <li class="seamTextUnorderedListItem">Assessments, at 1 week and 5 months after surgical consultation</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">There are two phases to this study. </li> <li class="seamTextUnorderedListItem">In phase I, the researchers will collect feedback about the Decision Aid from breast cancer patients age 70 and over who were treated at least six months ago and their family members and clinicians. </li> <li class="seamTextUnorderedListItem">The researchers will use this feedback to improve the Decision Aid. </li> <li class="seamTextUnorderedListItem">In Phase II, the researchers will see if the revised Decision Aid helps women age 70 and older who have been diagnosed with breast cancer make treatment decisions.</li> </ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02823262' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02823262?term=NCT02823262&rank=1' target='_blank'>The Decision Aid</a> </li></ul>
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