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In response to COVID-19, some breast cancer trials have temporarily stopped enrolling new patients. Use the contact information in our trial listings to call or email the research site for information about a trial's status.

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(Last updated: July 01, 2022)

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1

NEAREST SITE: 28 miles
Kaiser Permanente - Northern California
Vallejo,CA

VISITS: Please contact research site

PHASE: NA

NCT ID: NCT03061305

Molecular Profiling to Select Treatment for Advanced Breast Cancer

Profiling Biospecimens From Cancer Patients to Screen for Molecular Alterations Related to Treatment Selection (STRATA) Scientific Title

Purpose
To conduct a test of your tumor to determine if there are approved therapies or clinical trials targeting the mutations or biomarkers found in your tumor.
Who is this for?
People with advanced (some stage III) or 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"> Molecular profiling will be done on your tumor sample at no cost.</p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A sample of your tumor will be tested for certain mutations and biomarkers. </li> <li class="seamTextUnorderedListItem">Your doctor will be told if there are treatments or clinical trials available for people with the mutations or biomarkers found in your tumor. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling patients with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03061305' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/testing/types/broad-molecular-profiling-tests' target='_blank'>Breastcancer.org: Broad Molecular Profiling Tests</a> </li><li class='seamTextUnorderedListItem'><a href='https://unclineberger.org/research/octr/our-research/strata-trial' target='_blank'>UNC Lineberger Comprehensive Cancer Center: Study website</a> </li></ul>
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2

NEAREST SITE: 28 miles
Stanford University Medical Center
Palo Alto,CA

VISITS: 1 visit that coincides with surgery

PHASE: II

NCT ID: NCT04440982

Detection of Cancer Cells During Lumpectomy in Women Who Received Therapy Before Surgery

Feasibility Study to Evaluate Performance of the LUM Imaging System for Intraoperative Detection of Residual Tumor in Patients With Breast Cancer Receiving Neoadjuvant Therapy Scientific Title

Purpose
To study the safety and effectiveness of using the LUM Imaging System during breast conserving surgery (lumpectomy) to identify any remaining cancer cells in the tissue around where the tumor was removed.
Who is this for?
Women with DCIS or stage I, stage II or stage III breast cancer who will have a lumpectomy (breast conserving surgery) after receiving treatment.    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 and receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: LUM Imaging System to see if cancer cells remain</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LUM015, by IV, 2 to 6 hours prior to surgery</li> <li class="seamTextUnorderedListItem">LUM imaging to decide if more breast tissue should be removed during surgery</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard Care to see if cancer cells remain</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LUM015, by IV, 2 to 6 hours prior to surgery</li> <li class="seamTextUnorderedListItem">Standard care to decide if more breast tissue should be removed during surgery</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The LUM Imaging System uses a dye, called LUM015, that is injected into your body before surgery.</li> <li class="seamTextUnorderedListItem">The LUM015 dye then attaches to cancer cells in breast tissue. This can help the surgeon determine if cancer cells remain in the tumor bed after the DCIS or tumor has been removed. If cancer cells remain, your surgeon will remove more tissue.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04440982' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/surgery/assessing-margins/' target='_blank'>Susan G. Komen: Assessing Margins after Breast Surgery</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.lumicell.com/product-technology/technology-overview.php' target='_blank'>Lumicell Medical Device Information Page: Lumicell System</a> </li></ul>
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3

NEAREST SITE: 602 miles
Huntsman Cancer Institute
Salt Lake City,UT

VISITS: 1 visit

PHASE: II

NCT ID: NCT04252859

Using a PET/CT Scan to Find Lobular Breast Cancer Cells Before Surgery for Stage I-IV Lobular Breast Cancer

[18F]Fluoroestradiol-PET/CT Imaging of Invasive Lobular Carcinoma Scientific Title

Purpose
To study whether a PET/CT scan using a (18F) FES tracer is more effective at finding lobular breast cancer cells than the standard of care.
Who is this for?
People diagnosed with stage I, stage II or stage III lobular breast cancer within the last 3 months and who have not yet had surgery and people with stage IV (metastatic) lobular breast cancer diagnosed within the last 3 months    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">PET/CT scan using (18F) FES tracer, 1 time</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer. A tracer looks for and attaches to cancer cells.</li> <li class="seamTextUnorderedListItem">Lobular breast cancer is a subtype of breast cancer. It is estimated that 10 to 15 percent of all breast cancers are lobular. </li> <li class="seamTextUnorderedListItem">Standard of care PET/CT scans that use a FDG tracer generally do not find lobular breast cancer tumors as well as they find ductal breast cancer tumors and PET/CT scans are not usually given to people with stage I-II lobular breast cancer. </li> <li class="seamTextUnorderedListItem">This imaging trial will use a tracer called (18F)Fluoroestradiol (FES). Researchers believe this tracer is better at locating and attaching to lobular cancer cells than the standard of care tracer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04252859' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://lobularbreastcancer.org/imagingilc/' target='_blank'>Lobular Breast Cancer Alliance: Imaging and Lobular Breast Cancer</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 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 people 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, you will receive the treatment the 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, you 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, you 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">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">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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5

NEAREST SITE: 1678 miles
University of Wisconsin Carbone Cancer Center
Madison,WI

VISITS: 1 visit every 3 to 4 weeks, ongoing

PHASE: NA

NCT ID: NCT04174352

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 Scientific Title

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.    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">Tamoxifen (Nolvadex®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">FES PET/CT scan, every 3 to 4 weeks, ongoing</li></ul>
  • <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>
  • <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>
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6

NEAREST SITE: 2260 miles
Allegheny Health Network Cancer Institute
Pittsburgh,PA

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></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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7

NEAREST SITE: 2406 miles
UNC Lineberger Comprehensive Cancer Center
Chapel Hill,NC

VISITS: 1 visit

PHASE: NA

NCT ID: NCT03769415

HARMONY: Using a Genomic 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 Scientific Title

Purpose
To study if genomic 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.    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">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>
  • <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 genomic 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>
  • <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>
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