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(Last updated: July 24, 2021)

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1

NEAREST SITE: 2 miles
Zuckerberg San Francisco General Hospital
San Francisco,CA

VISITS: 3 or 5 visits, over 5 years

PHASE: III

NCT ID: NCT03233191

Breast Cancer Screening Based on Individual Risk Factors and Comparing the Effectiveness of 3D to 2D Mammography

Tomosynthesis Mammographic Imaging Screening Trial (TMIST) Scientific Title

Purpose
To study if risk-based screening for breast cancer is as safe and effective as age-based screening and if (3D) mammography is better than (2D) mammography at finding early-stage tumors.
Who is this for?
Women, age 45 to 74, who have never been diagnosed with DCIS or breast cancer. You must not have had a screening mammogram within the last 11 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 be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Digital mammogram (2D)</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">if you are premenopausal or postmenopausal with 1 risk factor, mammogram, once a year, for five years</li> <li class="seamTextUnorderedListItem">if you are postmenopausal, mammogram, every 2 years, for five years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Digital tomosynthesis mammogram (3D)</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">if you are premenopausal or postmenopausal with 1 risk factor, mammogram, once a year, for five years</li> <li class="seamTextUnorderedListItem">if you are postmenopausal, mammogram, every 2 years, for five years</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Most breast cancer screening guidelines are based upon a woman's age--not her individualized risk of developing breast cancer. </li> <li class="seamTextUnorderedListItem">For this trial, you will receive annual mammograms if you are premenopausal or postmenopausal with at least one risk factor.</li> <li class="seamTextUnorderedListItem">Risk factors if you are 45-69: dense breasts, a first degree relative with breast cancer, an inherited genetic mutation that increases your risk of developing cancer, or taking hormone therapy.</li> <li class="seamTextUnorderedListItem">Risk factors if you are 70-74: dense breasts or taking hormone therapy.</li> <li class="seamTextUnorderedListItem">Digital tomosynthesis (3D) mammography is approved by the FDA but is not considered the standard of care for breast cancer screening.</li> <li class="seamTextUnorderedListItem">Digital (2D) mammography is the standard of care for breast cancer screening.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03233191' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ecog-acrin.org/tmist' target='_blank'>ECOG-ACRIN Cancer Research Group Trial Information Page: TMIST</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/symptoms/testing/types/dig_tomosynth' target='_blank'>Breastcancer.org: Digital Tomosynthesis</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/breast_center/treatments_services/breast_cancer_screening/digital_mammography/index.html' target='_blank'>Johns Hopkins Medicine: Digital Mammography</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2017/tmist-breast-cancer-screening' target='_blank'>NCI Cancer Currents Blog: TMIST Trial Aims to Provide Clarity on Breast Cancer Screening Approaches</a> </li></ul>
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2

NEAREST SITE: 3 miles
University of California San Francisco
San Francisco,CA

VISITS: Online surveys

PHASE: NA

NCT ID: NCT02620852

WISDOM Study: Women Informed to Screen Depending on Measures of Risk

Enabling a Paradigm Shift: A Preference-Tolerant RCT of Personalized vs. Annual Screening for Breast Cancer Scientific Title

Purpose
To learn if risk-based breast screening is as safe and effective as annual mammogram screening for reducing risk and detecting breast cancer.
Who is this for?
Women between the ages of 40 and 70 who have never been diagnosed with breast cancer or ductal carcinoma in situ (DCIS).    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, or you can choose your study group. </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Personalized, Risk-Based Screening</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Screening recommendations based on comprehensive, personal risk assessment</li> <li class="seamTextUnorderedListItem">Saliva sample genetic test</li> <li class="seamTextUnorderedListItem">Online, annual health questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard Annual Screening</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Screening recommendation for annual mammograms</li> <li class="seamTextUnorderedListItem">Online, annual health questionnaires</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized risk-based screening will take multiple risk factors into consideration, including genetic markers, to determine how often you should have a mammogram.</li> <li class="seamTextUnorderedListItem">This study will help researchers learn if risk-based screening, which helps women learn more about their personal breast cancer risk, is less stressful and as successful at detecting breast cancer as annual screening. </li> <li class="seamTextUnorderedListItem">This study is available in English and Spanish.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02620852' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.thewisdomstudy.org/' target='_blank'>WISDOM: Study Information Page</a> </li></ul>
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3

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

VISITS: Coincides with surgery

PHASE: III

NCT ID: NCT03686215

Detection of Residual Cancer Cells During Breast Cancer Surgery

Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer Scientific Title

Purpose
To test the safety and effectiveness of using the LUM Imaging System during breast surgery to identify cancer cells.
Who is this for?
Women with DCIS or stage I, stage II or stage III breast cancer who will be having breast cancer surgery.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will 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">LUM015, by IV, 2 to 6 hours prior to surgery</li> <li class="seamTextUnorderedListItem">LUM imaging to guide additional tissue removal, during surgery</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LUM015, by IV, 2 to 6 hours prior to surgery</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The LUM Imaging System uses a dye, called LUM015, injected prior to surgery. </li> <li class="seamTextUnorderedListItem">The dye attaches to cancer cells in breast tissue. </li> <li class="seamTextUnorderedListItem">This can help the surgeon determine if cancer cells remain in the tumor bed after the DCIS or primary tumor has been removed.</li> <li class="seamTextUnorderedListItem">If the imaging identifies that there may be cancer cells remaining, the surgeon will remove an additional piece of tissue. This process will be continued until a negative reading from the device is obtained.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03686215' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.lumicell.com/' target='_blank'>Sponsor site: Lumicell</a> </li><li class='seamTextUnorderedListItem'><a href='http://cancerres.aacrjournals.org/content/78/13_Supplement/CT166' target='_blank'>Cancer Research Abstract: LUM Imaging System</a> </li></ul>
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4

NEAREST SITE: 74 miles
University of California Davis Comprehensive Cancer Center
Sacramento,CA

VISITS: 2 visits over 4 months

PHASE: II

NCT ID: NCT04316117

Using PET/CT Scans to See How Breast Cancer That Has Spread to the Bones is Responding to Therapy

FDG PET to Assess Therapeutic Response in Patients With Bone-Dominant Metastatic Breast Cancer, FEATURE Scientific Title

Purpose
To study if PET/CT scans with a FDG tracer find tumors missed by standard of care imaging and can see how breast cancer tumors that have spread to the bones are responding to therapy.
Who is this for?
People with stage IV (metastatic) breast cancer that has spread to their bones and who have not received more than 3 chemotherapies 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">FDG tracer, by IV, followed by PET/CT scan, 2 times (1 scan before treatment, 1 scan 3 months after starting treatment)</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 that can look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">This imaging trial will use a tracer called FDG (fluorodeoxyglucose). </li> <li class="seamTextUnorderedListItem">FDG produces color-coded images that show normal and cancerous tissue.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04316117' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ecog-acrin.org/clinical-trials/ea1183-educational-materials' target='_blank'>ECOG-ACRIN Study Information Page: FEATURE</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/tests/pet-ct-scan' target='_blank'>Cancer Research UK: PET-CT Scan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.docpanel.com/blog/post/understanding-your-fdg-pet-scan' target='_blank'>Docpanel: Understanding Your FDG PET Scan</a> </li></ul>
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5

NEAREST SITE: 198 miles
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT03723928

Imaging and Tumor Mark Tests to Monitor Metastatic HR Positive, HER2 Negative Breast Cancer

Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored With Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients With Metastatic Hormone Receptor Positive Breast Cancer (SWOG-S1703) Scientific Title

Purpose
To study if blood tests that look for tumor markers are as good as or better than imaging with PET and/or CT scans (the current standard of care) to determine if a tumor is growing.
Who is this for?
People with metastatic (stage IV) hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who are planning to have first line treatment for metastatic disease or have started treatment within the past month, and have at least one elevated tumor marker.    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: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imaging (CT and/or PET scans), at least every 3 months, ongoing</li> <li class="seamTextUnorderedListItem">Tumor Marker Test, if ordered by your doctor</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor Marker Tests, every 1 to 2 months, ongoing</li> <li class="seamTextUnorderedListItem">Imaging (CT and/or PET scans), only if need is shown by a Tumor Marker Test</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draws</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This imaging trial will compare using blood tests to PET/CT scans for monitoring tumor growth. </li> <li class="seamTextUnorderedListItem">The tumor markers that will be tested for in this study are CA 15-3, CA27.29, and CEA.</li> <li class="seamTextUnorderedListItem">The imaging tests will be those ordered by your doctor.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03723928' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/testing/types/blood_marker' target='_blank'>Breastcancer.org: Blood Marker Tests</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/about-us/collaborations/top-five-list-oncology/choosing-wisely®-top-five-cancer-related-tests-procedures-and-treatments-many-patients-do-not-need/topic-4-follow-tumor-marker-tests-and-imaging-tests-people-treated-breast-cancer' target='_blank'>ASCO Cancer.net: Follow-up Tumor Marker Tests and Imaging Tests for People Treated for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/diagnosis-staging/diagnosis/tumor-markers-fact-sheet' target='_blank'>NCI: Tumor Markers</a> </li><li class='seamTextUnorderedListItem'><a href='https://ozarkscancerresearch.org/wp-content/uploads/2019/04/SWOG-S1703.pdf' target='_blank'>Cancer Research for the Ozarks: Trial Information Page</a> </li></ul>
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6

NEAREST SITE: 336 miles
University of California at Los Angeles
Los Angeles,CA

VISITS: 1 visit

PHASE: NA

NCT ID: NCT04297020

Studying the Effects of Anti-Estrogen Therapy on the Brain of Women with Stage I-III Breast Cancer

Brain Health in Breast Cancer Survivors: Interaction of Menopause and Endocrine Therapy Scientific Title

Purpose
To see if anti-estrogen therapy affects brain health.
Who is this for?
Women between the ages of 35 and 65 who are currently taking anti-estrogen therapy for stage I, stage II, or stage III breast cancer and who did not receive chemotherapy. This trial is also enrolling women who have never been diagnosed with 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 receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 Brain fMRI (functional MRI)</li> <li class="seamTextUnorderedListItem">Cognitive testing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial will use an advanced brain MRI technique called functional MRI (fMRI).</li> <li class="seamTextUnorderedListItem">fMRI measures changes in blood flow that happen during mental activity. </li> <li class="seamTextUnorderedListItem">Research suggests that the cognitive issues experienced by some people who receive treatment for breast cancer--also called <q>chemo brain</q>--may actually be caused by anti-estrogen therapy and not chemotherapy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04297020' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medscape.com/viewarticle/932091' target='_blank'>MedScape: In Breast Cancer, Is Chemobrain Really Endocrine Brain?</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Functional_magnetic_resonance_imaging' target='_blank'>Wikipedia: Functional MRI</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.radiologyinfo.org/en/info.cfm?pg=fmribrain' target='_blank'>RadiologyInfo.org: fMRI</a> </li></ul>
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7

NEAREST SITE: 347 miles
South Pasadena Cancer Center
South Pasadena,CA

VISITS: 2 visits

PHASE: NA

NCT ID: NCT01992432

Studying the Effect of Chemotherapy on the Brain in Older Women

A Pilot Study of Structural and Functional Brain Magnetic Resonance Imaging Findings of Chemotherapy Toxicity in Older Women With Breast Cancer Scientific Title

Purpose
To study how chemotherapy affects the brain of older women.
Who is this for?
Women, 65 or older, with stage I, stage II, or stage III breast cancer who received chemotherapy after their surgery.    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: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain fMRI (functional MRI) before and after chemotherapy</li> <li class="seamTextUnorderedListItem">Cognitive testing before and after chemotherapy</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy can cause short-and long-term difficulties with cognitive functioning, a problem often referred to as <q>chemo brain.</q> </li> <li class="seamTextUnorderedListItem">Older adults may be at increased risk of developing cognitive problems from chemotherapy. </li> <li class="seamTextUnorderedListItem">This study will use advanced MRI techniques to characterize the changes that occur in the brain.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01992432' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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8

NEAREST SITE: 348 miles
USC Norris Comprehensive Cancer Center
Los Angeles,CA

VISITS: 1 visit

PHASE: NA

NCT ID: NCT01755208

Using Light-Scattering Spectroscopy in Women with Stage II-III Breast Cancer (or without Breast Cancer) Having a Mammogram at University of Southern California

Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study Scientific Title

Purpose
To study if light-scattering spectroscopy can tell apart women with no breast cancer from women with stage II or stage III breast cancer.
Who is this for?
Women with stage II or stage III breast cancer, or women without breast cancer, scheduled to have a mammogram at the University of Southern California.    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">Light-scattering spectroscopy in addition to standard of care</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Light-scattering spectroscopy (LSS) is an imaging technique that does not require the removal of tissue samples and can provide quick results.</li> <li class="seamTextUnorderedListItem">LSS may be able to identify cell abnormalities more effectively than a biopsy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01755208' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ncbi.nlm.nih.gov/pubmed/17280544' target='_blank'>Journal Article: Optical Diagnostic Technology Based on Light Scattering Spectroscopy for Early Cancer Detection</a> </li></ul>
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9

NEAREST SITE: 374 miles
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange,CA

VISITS: 1 visit a week for 3 months

PHASE: II

NCT ID: NCT02436993

Two Chemotherapies and a Targeted Therapy Before Surgery for Stage I-III Breast Cancer

A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting Scientific Title

Purpose
To evaluate the safety and effects (good and bad) of giving chemotherapy with Avastin or Perjeta before surgery and to study whether magnetic resonance imaging (MRI) is a good tool for monitoring and predicting how a tumor will respond to the treatment.
Who is this for?
Women with stage I, stage II, or stage III breast cancer who have not yet had surgery or any other 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 assigned to 1 of 2 groups and receive the following for 3 months before surgery: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: HER2-negative</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), weekly</li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), every other week</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: HER2-positive</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carbolplain (Paraplatin®), by IV, weekly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, weekly</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs routinely used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®) is a targeted therapy that keeps tumors from growing the blood vessels they need to survive.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are targeted therapies used to treat HER2 positive breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02436993' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://ww5.komen.org/BreastCancer/Neoadjuvant.html' target='_blank'>Susan G. Komen: Neoadjuvant Therapies</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/targeted_therapies/avastin' target='_blank'>Breastcancer.org: Avastin</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/targeted_therapies/herceptin' target='_blank'>Breastcancer.rog: Herceptin</a> </li></ul>
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10

NEAREST SITE: 602 miles
Huntsman Cancer Institute/University of Utah
Salt Lake City,UT

VISITS: 1 visit

PHASE: II

NCT ID: NCT02398773

Predicting Which Tumors in People With Newly Diagnosed Metastatic ER+ Breast Cancer Will Respond to Hormone Therapy

[18F] Fluoroestradiol (FES) PET as a Predictive Measure for Endocrine Therapy in Patients With Newly Diagnosed Metastatic Breast Cancer (EAI142) Scientific Title

Purpose
To see if FES-PET/CT scans can predict how ER+ breast cancer will respond to anti-hormone therapy.
Who is this for?
People with newly diagnosed metastatic (stage IV) breast cancer who have not yet received hormone therapy for metastatic disease and who have at least one tumor that is estrogen receptor positive (ER+).    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 undergo the following up to 30 days before starting standard hormone therapy: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FES tracer, by IV over 2 minutes</li> <li class="seamTextUnorderedListItem">followed by PET/CT imaging</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">May undergo a second FES-PET/CT at least 24 hours and no later than 10 days after the initial study</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tracers are chemicals that are used to find cancer cells in the body. </li> <li class="seamTextUnorderedListItem">This imaging trial will use the tracer fluoroestradiol (FES)--a tracer that finds estrogen receptors in breast cancer tumors. </li> <li class="seamTextUnorderedListItem">Giving an FES tracer before a PET/CT scan may help doctors find ER+ breast cancer cells that have spread to other parts of the body (metastasized).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02398773' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/clinical-trials/cls-20347030' target='_blank'>Mayo Clinic Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.radiologyinfo.org/en/info.cfm?pg=pet' target='_blank'>RadiologyInfo.org: Positron Emission Tomography - Computed Tomography (PET/CT)</a> </li><li class='seamTextUnorderedListItem'><a href='http://clincancerres.aacrjournals.org/content/23/2/407' target='_blank'>AACR: Estrogen Receptor Binding and Glycolytic Activity Predict Progression-Free Survival on Endocrine Therapy</a> </li></ul>
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11

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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12

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

VISITS: 2 visits over 1 week

PHASE: NA

NCT ID: NCT02317783

Using Brain Imaging to Study the Effect of Chemotherapy on the Brain

Amyloid Plaque Deposition in Chemotherapy-Induced Cognitive Impairment Scientific Title

Purpose
To use PET scans to study how chemotherapy affects the brain.
Who is this for?
Women with stage I, stage II, or stage III breast cancer who received chemotherapy after surgery within the last three years.    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 2 FDG-PET scans using flutemetamol over a week</p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Many cancer patients have thinking and memory problems due to cancer or its treatments. The reasons for this <q>mental fog,</q> referred to as chemo brain, are not always known.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02317783' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02317783?term=NCT02317783&rank=1' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.org/treatment/treatmentsandsideeffects/physicalsideeffects/chemotherapyeffects/chemo-brain' target='_blank'>Cancer.org: Chemo Brain</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm372261.htm' target='_blank'>FDA.gov: Imaging Drug, Flutemetamol</a> </li></ul>
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13

NEAREST SITE: 1481 miles
UT Health San Antonio Mays Cancer Center
San Antonio,TX

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT03799523

Surface-Image Guidance to Improve Breast Radiation Therapy in Women with Stage I-III Breast Cancer or DCIS

Demonstration of a Novel Approach Using Surface-Image Guidance to Improve Delivery of Breast Radiotherapy Scientific Title

Purpose
To investigate if semi-permanent marks with specialized light-based surface imaging (SIGRT) are as good as or better than permanent tattoos in guiding radiation therapy.
Who is this for?
Women with ductal carcinoma in situ (DCIS), stage I, stage II, or stage III breast cancer planning to have radiation after surgery.    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Temporary skin markings, during radiation therapy</li> <li class="seamTextUnorderedListItem">Surface imaging, during radiation therapy</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tattoos or skin markings help radiologists target the tumor. </li> <li class="seamTextUnorderedListItem">Light-based surface imaging may also help radiologists target the tumor.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03799523' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncolink.org/cancer-treatment/radiation/introduction-to-radiation-therapy/pictorial-overview-of-the-radiation-therapy-treatment-process' target='_blank'>OncoLink: Pictorial Overview of the Radiation Therapy Treatment Process</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/radiotherapy/external/planning/skin-markings' target='_blank'>Cancer Research UK: Radiotherapy Tattoos</a> </li></ul>
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14

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

VISITS: 1 to 2 visits

PHASE: I

NCT ID: NCT03604315

An Experimental PET/CT Scan to Find PARP-Expressing Tumor Cells

Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CT Scientific Title

Purpose
To study the safety and effectiveness of using a PET/CT scan with the experimental tracer F-18.
Who is this for?
People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer or DCIS.    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">F-18 tracer, by IV, then a PET/CT scan</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 that can look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">The tracer used in this imaging trial is called fluorine F 18 fluorthanatrace (F-18)--it binds to PARP expressing tumor cells (PARP is a protein over expressed in certain cancers). </li> <li class="seamTextUnorderedListItem">You do not need to have an inherited BRCA1/2 mutation to enroll in this trial but researchers are studying whether F-18 works better in inherited BRCA1/2+ cancers. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of solid tumors.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03604315' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/diagnostics/10123-pet-scan' target='_blank'>Cleveland Clinic: PET Scan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/fluorine-f-18-fluorthanatrace' target='_blank'>NCI Drug Dictionary: Fluorine F 18 Fluorthanatrace</a> </li></ul>
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15

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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16

NEAREST SITE: 1739 miles
Washington University School of Medicine
Saint Louis,MO

VISITS: At least 7 visits over 3 years

PHASE: II

NCT ID: NCT03862131

PROactive Evaluation to Reduce Treatment-Related Heart Problems (PROACT)

PROactive Evaluation of Function to Avoid CardioToxicity Scientific Title

Purpose
To look at whether MyoStrain® measurements are as good as or better than traditional MRI measurements for predicting and reducing a patient's risk of developing treatment-related heart problems.
Who is this for?
People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer scheduled to start cancer 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 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">Cardiac MRI at 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years after the baseline visit</li> <li class="seamTextUnorderedListItem">MyoStrain® measurements</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cardiac MRI at 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years after the baseline visit</li> <li class="seamTextUnorderedListItem">Standard of care MRI measurements (LVEF and LVEDV/LVESV)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MyoStrain® analyzes data collected from MRI heart scans to assess a patient's risk of developing heart problems.</li> <li class="seamTextUnorderedListItem">This imaging trial will compare if measurements taken by MyoStrain® are better able to predict who will develop heart problems from cancer therapies than the traditional measurements taken by MRI.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03862131' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.myocardialsolutions.com/' target='_blank'>Myocardial Solutions Product Information Page: MyoStrain®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nccn.org/patients/resources/life_with_cancer/managing_symptoms/cardiac_toxicity.aspx' target='_blank'>National Comprehensive Cancer Network: Cardiac Toxicity</a> </li></ul>
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17

NEAREST SITE: 1941 miles
Animated Dynamics, Inc.
Indianapolis,IN

VISITS: 1-2 visits

PHASE: NA

NCT ID: NCT03164863

Using Onco 4D™ to Select Chemotherapy for Stage I-III Breast Cancer

Feasibility Study of Motility Contrast Tomography for Predicting Therapeutic Response Scientific Title

Purpose
To study if the Onco 4D test can predict how tumors will respond to chemotherapy.
Who is this for?
People diagnosed with breast cancer who are eligible to receive chemotherapy as part of their treatment and who have not yet had a biopsy or surgery. You may also enroll if you had an abnormal mammogram, ultrasound, or clinical exam.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 or 2 biopsies</li> <li class="seamTextUnorderedListItem">Your biopsy sample will be evaluated using motility contrast tomography (MTC)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This study is evaluating the potential benefits of a new technology called Onco 4D™ to help predict chemotherapy response in breast cancer patients.</li> <li class="seamTextUnorderedListItem">Onco 4D uses motility contrast tomography to determine how your cancer is likely to respond to different types of chemotherapy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03164863' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.purdue.edu/newsroom/releases/2016/Q2/closing-of-series-a-funding-to-help-purdue-biotech-company-improve-targeted-cancer-treatments.html' target='_blank'>Purdue University: Onco 4D™</a> </li></ul>
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18

NEAREST SITE: 2438 miles
Walter Reed Army Medical Center
Washington,DC

VISITS: 1 visit

PHASE: NA

NCT ID: NCT01322750

A Circulating Tumor Cell Test To Screen For Breast Cancer At Walter Reed National Military Medical Center

Circulating Tumor Cells (CTCs): A Potential Screening Test for Clinically Undetectable Breast Carcinoma Scientific Title

Purpose
To study if a blood test for circulating tumor cells (CTCs) can reliably find breast cancer before your cancer has become clinically detectable (seen on a mammogram, ultrasound, or other imaging).
Who is this for?
People without breast cancer and people with DCIS, stage I, stage II, or stage III breast cancer who are having a diagnostic or therapeutic procedure (biopsy, lumpectomy, mastectomy) done at Walter Reed National Military Medical 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 have your blood drawn</p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Scientists are researching new techniques to screen for breast cancer.</li> <li class="seamTextUnorderedListItem">Breast cancer cells can leave the tumor and move through the blood stream before the tumor is clinically detectable.</li> <li class="seamTextUnorderedListItem">Circulating tumor cell tests look for these traveling cancer cells and may provide a simple, reliable, and cost-effective form of breast cancer screening.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01322750' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cbcp-research.org' target='_blank'>Walter Reed National Military Medical Center: Clinical Breast Care Project</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/symptoms/testing/types/blood_marker.jsp' target='_blank'>Breastcancer.org: Blood Marker Tests</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/types/breast/patient/breast-screening-pdq' target='_blank'>NCI: Breast Cancer Screening</a> </li></ul>
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19

NEAREST SITE: 2519 miles
Thomas Jefferson University
Philadelphia,PA

VISITS: 1 visit that coincides with surgery

PHASE: I-II

NCT ID: NCT02652923

Using an Ultrasound and an Experimental Contrast Agent During Surgery to Find Lymph Nodes in Women with Stage I-III Breast Cancer

Contrast Ultrasound Detection of Sentinel Lymph Nodes in Breast Cancer Patients Scientific Title

Purpose
To study the safety and effects of using Sonazoid -- a contrast agent used during an ultrasound -- to identify sentinel lymph nodes during surgery.
Who is this for?
Women age 21 or older with stage I, stage II, or stage III breast cancer who are planning to have surgery.    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">Sonazoid, by injection, once before ultrasound</li> <li class="seamTextUnorderedListItem">Lymph node ultrasound, during surgery</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A sentinel lymph node is the first lymph node under the arm to which the cancer cells are most likely to have spread.</li> <li class="seamTextUnorderedListItem">The standard practice to identify sentinel lymph nodes is to use a radioactive substance with imaging or colored dye with surgery.</li> <li class="seamTextUnorderedListItem">This study investigates the use of Sonazoid with an ultrasound to identify sentinel lymph nodes.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02652923' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sciencedirect.com/topics/medicine-and-dentistry/perfluorobutane' target='_blank'>Science Direct: Sonazoid (Perfluorobutane)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/20091006b#:~:text=A%20small%20study%20found%20that,had%20spread%20to%20those%20nodes.' target='_blank'>Breastcancer.org: Lymph Node Ultrasound Before Surgery Can Help Find Cancer Spread</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/patient-education/lymphatic-mapping-sentinel-node-biopsy' target='_blank'>Memorial Sloan Kettering Cancer Center: Lymphatic Mapping with Sentinel Node Biopsy</a> </li></ul>
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20

NEAREST SITE: 2567 miles
Memorial Sloan Kettering Cancer Center
New York,NY

VISITS: 1-2 visits

PHASE: NA

NCT ID: NCT01916122

A New Approach to Studying How ER+ Tumors Respond to Treatment

Fluorestradiol (FES) PET/CT for Imaging Estrogen Receptor Status Scientific Title

Purpose
To study whether PET/CT scans that use a FES tracer can show if ER+ breast cancer is responding to therapy.
Who is this for?
People with stage I, stage II, stage III, or metastatic (stage IV) estrogen receptor positive (ER+) breast cancer who are receiving treatment at Memorial Sloan Kettering 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 receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FES tracer, by IV</li> <li class="seamTextUnorderedListItem">followed by PET/CT scan</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 that can look for and attach to cancer cells. </li> <li class="seamTextUnorderedListItem">A tracer called 16a-18F-fluoroestradiol (FES) looks for and attaches to estrogen receptors. </li> <li class="seamTextUnorderedListItem">Researchers are using this imaging trial to study if the tracer FES can be used to monitor the effect a cancer therapy is having on the cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01916122' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/ency/article/003827.htm' target='_blank'>MedlinePlus: PET Scan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sciencedaily.com/releases/2018/08/180806104245.htm' target='_blank'>Science Daily: PET Tracer Identifies Estrogen Receptor Expression Differences in Breast Cancer</a> </li></ul>
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21

NEAREST SITE: 2693 miles
Massachusetts General Hospital
Boston,MA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03285412

Additional Therapy after Standard Treatment for Women with Stage I-III, ER+, HER2- Breast Cancer with Residual Disease by ctDNA Testing

Phase II Study of CDK 4/6 Inhibitor, LEE011 (Ribociclib), in Combination With Adjuvant Endocrine Therapy at Varying Duration for ER-positive Breast Cancer (LEADER) Scientific Title

Purpose
To study the anti-cancer activity, safety, and side effects of giving additional treatment with a CDK 4/6 inhibitor to treat residual disease defined as testing positive for ctDNA.
Who is this for?
Women with stage I, stage II, or stage III estrogen receptor-positive (ER+), HER2 negative (HER2-) breast cancer who have completed treatment (other than hormone therapy) for breast cancer and test positive for detectable disease with a ctDNA test. You will be given a blood test to look for ctDNA. You may enroll in this trial up to ten years after diagnosis.    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> If your ctDNA test comes back positive for residual disease, 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">Ribociclib (Kisqali®), by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy</li></ul>
  • <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">Researchers are studying if a test looking for ctDNA in the bloodstream can determine if there will be a recurrence (coming back) of a person's breast cancer.</li> <li class="seamTextUnorderedListItem">The ctDNA blood test used in this trial is called Signatera.</li> <li class="seamTextUnorderedListItem">This trial is also studying if a recurrence can be stopped or delayed by giving people with a positive ctDNA test additional treatment.</li> <li class="seamTextUnorderedListItem">The additional treatment in this trial includes Ribociclib (Kisqali®).</li> <li class="seamTextUnorderedListItem">Palbociclib is commonly used with anti-estrogen therapy for metastatic, hormone-positive (ER+ and/or PR+), HER2-negative (HER2-) breast cancer, but its use in this trial is considered experimental.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03285412' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.natera.com/oncology/signatera-advanced-cancer-detection/' target='_blank'>Natera ctDNA Test Information Page: Signature</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/genetics/understanding/testing/circulatingtumordna/' target='_blank'>What is Circulating Tumor DNA and How is it Used to Diagnose and Manage Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/january-25-2021/a-tale-of-two-cdk46-inhibitors-in-early-breast-cancer/' target='_blank'>The ASCO Post: A Tale of Two CDK4/6 Inhibitors in Early Breast Cancer</a> </li></ul>
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22

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

VISITS: Number of visits unavailable, over 1 year

PHASE: NA

NCT ID: NCT02666378

Detecting Treatment-Related Cardiotoxicity in HER2 Positive Breast Cancer

Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer Scientific Title

Purpose
To determine whether Cardiac Magnetic Resonance Imaging (CMR) and Echocardiogram (ECHO) tests can be used to identify early signs of heart problems that can be caused by Doxil and Herceptin.
Who is this for?
Women with HER2 positive breast cancer who are going to be treated with doxorubicin (Doxil®) and trastuzumab (Herceptin®) after surgery.    Full eligibility criteria
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  • <p class="seamTextPara"> You will undergo the following before treatment with chemotherapy and at predetermined times during and after treatment: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI (Cardiac Magnetic Resonance Imaging, CMR)</li> <li class="seamTextUnorderedListItem">Ultrasound (Echocardiogram, ECHO)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This study is investigating whether Cardiac Magnetic Resonance Imaging (CMR) and Echocardiogram (ECHO) tests can be used to identify early signs of heart problems that can be caused by Doxil and Herceptin.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02666378' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/tx-w-herceptin-needs-heart-monitoring' target='_blank'>Breastcancer.org: Women Treated With Herceptin Need Heart Monitoring</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/heart-meds-reduce-herceptin-cardiac-damage' target='_blank'>Breastcancer.org: Medicine for Herceptin Related Heart Damage</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/20111005' target='_blank'>Breastcancer.org: Herceptin Related Heart Damage</a> </li></ul>
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23

NEAREST SITE: 2693 miles
Brigham and Women's Hospital
Boston,MA

VISITS: 1 visit every 6 months, for 2 years

PHASE: NA

NCT ID: NCT04030507

Using MRIs to Screen for Brain Metastases in Advanced Breast Cancer

Screening Magnetic Resonance Imaging of the Brain in Patients With Metastatic Breast Cancer Managed With First/Second Line Chemotherapy or Inflammatory Breast Cancer Managed With Definitive Intent: A Prospective Study Scientific Title

Purpose
To study if using MRIs to screen for brain metastases (breast cancer that has spread to the brain) is safe and finds brain metastases earlier than the standard of care (no screening).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer who will be starting their first or second chemotherapy for advanced disease.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be assigned to 1 of 3 groups depending upon your cancer subtype: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Triple negative</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain MRI, every 6 months for 2 years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Inflammatory</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain MRI, every 6 months for 2 years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Hormone positive or HER2 positive</i> </p> <p class="seamTextPara"> People in Group 3 will be randomly assigned to receiving screening or no screening </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Screening group</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain MRI, every 6 months for 2 years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">No screening group</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No brain MRIs</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain metastases (brain mets) is when breast cancer has spread to the brain. </li> <li class="seamTextUnorderedListItem">The standard of care for metastatic breast cancer does not include ongoing screening for brain metastases.</li> <li class="seamTextUnorderedListItem">This imaging trial will use regularly scheduled MRIs (magnetic resonance imaging) to look for brain mets.</li> <li class="seamTextUnorderedListItem">Researchers believe adding brain metastases screening to the standard of care will help doctors find brain mets earlier--when they are smaller and potentially easier to manage.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04030507' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/mri/about/pac-20384768' target='_blank'>Mayo Clinic: Brain MRI</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.radiologybusiness.com/topics/policy/brain-mri-could-id-metastases-breast-cancer-patients-guidelines-dont-recommend-it' target='_blank'>Radiology Business: Brain MRI Could ID Metastases in Breast Cancer Patients</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertodaymag.org/Pages/Spring2019/Looking-for-Brain-Metastases.aspx' target='_blank'>Cancer Today: Looking for Brain Metastases</a> </li></ul>
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24

NEAREST SITE: 2694 miles
Boston Medical Center
Boston,MA

VISITS: Up to 7 visits

PHASE: NA

NCT ID: NCT02510456

Evaluating an Imaging Tool to Monitor Tumor Response to Chemo Given Before Surgery

Monitoring Neoadjuvant Chemotherapy Response In Breast Cancer Patients Using Diffuse Optical Spectroscopic Imaging (DOSI) Scientific Title

Purpose
Who is this for?
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  • <p class="seamTextPara"> All participants will undergo the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Up to 7 imaging scans at 7 different time points during the course of chemotherapy treatment</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02510456' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02510456?term=NCT02510456&rank=1' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='https://sites.google.com/site/dosiatbli/' target='_blank'>Information about DOSI</a> </li></ul>
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25

NEAREST SITE: 2694 miles
Massachusetts General Hospital
Boston,MA

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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  • <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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