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(Last updated: August 03, 2020)

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1

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

VISITS: Coincides with type of therapy

PHASE: NA

NCT ID: NCT03098576

Molecular Tumor Profiling to Select Targeted Therapies for People With Advanced Breast Cancer

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

Purpose
To study the effects (good and bad) of choosing a targeted therapy for treatment based on the results of molecular profiling of your tumor.
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 one is found in your tumor</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 genetic abnormality (mutation) is found in your tumor</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 trials.</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='https://ww5.komen.org/KomenPerspectives/Tumor-profiling-–-personalizing-treatment-for-breast-cancer.html' target='_blank'>Susan G. Komen: Tumor Profiling--Personalized Treatment For Breast Cancer</a> </li></ul>
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2

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 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 study if choosing cancer treatment based on your 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 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">This trial is also enrolling people with other types of cancer. </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://www.ncbi.nlm.nih.gov/pmc/articles/PMC3825646/' target='_blank'>Journal Article: Molecular Profiling for Breast Cancer</a> </li></ul>
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3

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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4

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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5

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

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT02965755

Tumor Molecular Profiling by Liquid Biopsy for Choosing Treatments for Metastatic Breast Cancer

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

Purpose
To study if a liquid biopsy (blood test) can give the same genetic information as a tumor biopsy (tumor tissue test) and if the genetic information can help doctors choose your next treatment.
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"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genetic profiling of your cancer using a liquid biopsy (blood test)</li> <li class="seamTextUnorderedListItem">Genetic profiling of your cancer using a tumor sample already in your medical records</li> <li class="seamTextUnorderedListItem">Possible treatment recommendations based on the results of the genetic profiling</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The information obtained from the liquid biopsy may help guide recommendations for your next treatment.</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/NCT02965755' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/KomenPerspectives/Tumor-profiling-–-personalizing-treatment-for-breast-cancer.html' target='_blank'>Susan G. Komen: Tumor Profiling-Personalizing Treatment for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2017/liquid-biopsy-detects-treats-cancer' target='_blank'>NCI Cancer Currents Blog: Liquid Biopsy</a> </li></ul>
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6

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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7

NEAREST SITE: 2693 miles
Dana Farber Cancer Institute
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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