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Find Breast Cancer Clinical Trials That Are Right For You

The clinical trials listed below are open in the U.S. for people with DCIS (stage 0), stage 1, stage 2, stage 3, or stage 4 (metastatic)
breast cancer. Clinical trials are available for people who are newly diagnosed with breast cancer, currently in treatment, experiencing
breast cancer recurrence, living with metastatic disease, as well as breast cancer survivors who have completed treatment.

Use the search box and filters to find a trial that’s right for you.


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(Last updated: May 02, 2024)

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Treatment

Brain Mets

BRCA1/2 (inherited)

Chemotherapy

Hormone Therapy

Leptomeningeal Disease

Radiation Oncology

Surgery

Surgery: Reconstruction

Targeted Therapy: All

Targeted Therapy: ADC

Targeted Therapy: Anti-HER2 Therapy

Targeted Therapy: CDK Inhibitors

Targeted Therapy: PARP Inhibitors

Targeted Therapy: Tumor Mutations

Targeted Therapy: Other Targeted Therapy

Vaccines and Immunotherapy

Other Treatment

Non-Treatment

Activities

Complementary and Integrative Medicine

Decision Support

Diagnosing Breast Cancer

Genetics/Family History

Having Children

Healthy/High Risk

Imaging

Lymphedema

Managing Side Effects

No Travel Required

Predicting Response to Treatment

Preventing Breast Cancer

Preventing Recurrence

Support/Education

Surveys/Interviews/Registries

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AKT

ALK

AR

BARD1

BRCA1/2 (tumor)

BRIP1

CD205

CD70

CHEK2 or CHEK1

dMMR/MSI-H

ESR1

FGFR

HER2/ERBB2

HLA

MET or C-Met

NTRK

PALB2

PIK3CA or PI3K

PTEN

RAD51

RAF (including BRAF)

RAS (KRAS or NRAS)

RB

ROS1

TP53

1

NEAREST SITE: 3 miles
Curebase
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT04510129

Collecting Tumor Samples to Develop a Test to Predict Response to Treatment

Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies Scientific Title

Purpose
To collect tumor samples that will be used to develop OncoPrism™, a test that helps providers predict response to immunotherapy.
Who is this for?
People with stage I, stage II, stage III, or stage IV (metastatic) triple negative (ER-, PR-, HER2-) breast cancer who have received or are planning to receive treatment with a PD-1/PD-L1 inhibitor. You must have received a biopsy before beginning treatment with a PD-1/PD-L1 inhibitor.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor samples</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OncoPrism™ is a test that helps providers predict response to immunotherapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people 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/NCT04510129' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cofactorgenomics.com/technology/' target='_blank'>Cofactor Genomics: OncoPrism™ Test</a> </li></ul>
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2

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

VISITS: 1 visit every week for 3-6 months

PHASE: II

NCT ID: NCT01042379

I-SPY 2: Personalized Treatment Before Surgery for Stage II-III Breast Cancer

I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2) Scientific Title

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of standard of care therapy compared to standard of care therapy with an experimental drug chosen based on your tumor's biomarkers.
Who is this for?
People with stage II or stage III breast cancer who have not yet received treatment and whose cancer is high-risk for recurrence.    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 before surgery: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> <li class="seamTextUnorderedListItem">At least 1 experimental therapy chosen based on your tumor's biomarkers</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">4 MRIs</li> <li class="seamTextUnorderedListItem">2 biopsies</li> <li class="seamTextUnorderedListItem">Blood draws</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy is treatment specific to an individual's tumor type, which are called biomarkers.</li> <li class="seamTextUnorderedListItem">This clinical trial has an adaptive design. This means that experimental drugs will be added during the trial, and experimental drugs that are not more effective than standard of care therapy will be removed.</li> <li class="seamTextUnorderedListItem">At least 80% of people who enroll will receive an experimental drug.</li> <li class="seamTextUnorderedListItem">All drugs will be given before surgery (neoadjuvant therapy). This allows researchers to see how your tumor is responding to the drugs.</li> <li class="seamTextUnorderedListItem">For this trial, cancer is considered high-risk for recurrence if it tests MammaPrint Low (only if your tumor is ER- or ER+, HER2+) or MammaPrint High.</li> <li class="seamTextUnorderedListItem">MammaPrint is a genomic test that identifies genes in your tumor and gives two types of recurrence risk scores: low risk or high risk.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01042379' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ispypatient.org/' target='_blank'>Quantum Leap Healthcare Collaborative: I-SPY Patient Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/32701140/' target='_blank'>Journal Article: Three-Year Follow-Up Analysis for the I-SPY 2 Adaptively Randomized Clinical Trial</a> </li></ul>
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3

NEAREST SITE: 3 miles
UCSF
San Francisco,CA

VISITS: 1 visit every 6 months for 5 years

PHASE: II

NCT ID: NCT06075953

Hormone Therapy and Active Surveillance for Women with HR+ DCIS

DCIS: RECAST Trial -Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a Breast Cancer Prevention Pilot Study Scientific Title

Purpose
To study if hormone therapy and active monitoring (MRIs and mammograms) is an effective way to treat and manage DCIS.
Who is this for?
Women with stage 0 (DCIS) hormone receptor positive (ER+ and/or PR+) breast cancer who have not yet received 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 receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy (standard of care or experimental) for 6 months</li> <li class="seamTextUnorderedListItem">MRI scans, 2 times within 6 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery (if needed)</li> </ul> <p class="seamTextPara"> or: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Continue on hormone therapy for 2-5 years</li> <li class="seamTextUnorderedListItem">Alternating MRI scan or mammogram every 6 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">After evaluation at 6 months, participants will either have surgery (if recommended) or continue on the treatment for 2-5 years.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li> <li class="seamTextUnorderedListItem">(Z)-endoxifen is similar to tamoxifen.</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy commonly used to treat hormone receptor positive breast cancer. The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs work by blocking the activity of estrogen in people with mutations in the ESR1 gene.</li> <li class="seamTextUnorderedListItem">Testosterone is a hormone that may reduce the risk of breast cancer.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">A mammogram is a breast cancer screening procedure involving taking an x-ray picture of the breast.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06075953' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.quantumleaphealth.org/portfolio/dcis' target='_blank'>Quantum Leap Healthcare Collaborative: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/ductal-carcinoma-in-situ' target='_blank'>Breastcancer.org: DCIS</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>
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4

NEAREST SITE: 7 miles
xCures
Oakland,CA

VISITS: Coincides with routine care

PHASE: NA

NCT ID: NCT05461430

Malignant Fluid Test to Predict Response to Treatment for Breast Cancer

Mass Response of Malignant Fluid Cells as a Biomarker for Rapid Therapy Guidance Scientific Title

Purpose
To study if a mass response test can predict your cancer's response to potential treatments.
Who is this for?
People with stage I, stage II, stage III, or metastatic (stage IV) breast cancer that have malignant fluid.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> Additional malignant fluid will be collected as part of a standard of care procedure.</p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Malignant fluid is the build up of fluid and cancer cells in your body.</li> <li class="seamTextUnorderedListItem">A cancer cell's mass response (weight change) indicates when a cancer cell begins responding to a drug before it dies.</li> <li class="seamTextUnorderedListItem">The results from the mass response test may be used by your doctor to choose your next treatment(s).</li> <li class="seamTextUnorderedListItem">Additional malignant fluid will be collected as part of a standard of care procedure.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05461430' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.travera.com/clinical-study-summary' target='_blank'>Travera Trial Information Page: TRV-003</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.travera.com/technology' target='_blank'>Travera: Mass Response Test</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.thoracic.org/patients/patient-resources/resources/malignant-pleural-effusions.pdf' target='_blank'>American Thoracic Society: Malignant Fluid</a> </li></ul>
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5

NEAREST SITE: 22 miles
Contra Costa Regional Medical Center
Martinez,CA

VISITS: Please contact research site

PHASE: II

NCT ID: NCT05564377

ComboMATCH: Targeted Therapy Directed by Genetic Testing for Advanced Breast Cancer

Molecular Analysis for Combination Therapy Choice (ComboMATCH) Scientific Title

Purpose
To use genetic testing to match people to treatments and help doctors plan better treatments.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received at least 1 line of therapy for advanced disease or who have no standard treatment options available.    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">Targeted therapy based on genetic testing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genetic tests look at the unique genetic material (genes) of tumor cells.</li> <li class="seamTextUnorderedListItem">People with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: AKT, ERK, MEK, NF1, RAF, RAS</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05564377' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/press-releases/2023/combomatch-precision-medicine-cancer-initiative' target='_blank'>National Cancer Institute: ComboMATCH</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/precision-medicine-breast-cancer/about/pac-20385240' target='_blank'>Mayo Clinic: Precision Medicine for Breast Cancer</a> </li></ul>
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6

NEAREST SITE: 28 miles
Stanford University
Stanford,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05101564

Biomarker Testing to Select Treatment for People with Stage I-III ER+, HER2- Breast Cancer

An Umbrella, Randomized, Controlled, Pre-Operative Trial Testing Integrative Subtype-Targeted Therapeutics in Hormone Receptor-Positive, HER2-Negative Breast Cancer Scientific Title

Purpose
To use biomarker testing to identify drugs that may slow tumor growth more than tamoxifen (Nolvadex®) or fulvestrant (Faslodex®) standard of care hormone therapy.
Who is this for?
People with stage I, stage II, or some stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer. You must not have received surgery, radiation, chemotherapy, or hormone therapy unless your breast cancer has come back (recurred).    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 4 groups after biomarker testing: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily for 2-3 weeks</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily for 2-3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily for 2-3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zotatifin, by IV, 1 time</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 1 time</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 1 time</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your tumor will be tested for levels of Ki-67.</li> <li class="seamTextUnorderedListItem">Ki-67 is a protein that is expressed in cancer cells. It increases as the cell prepares to divide into new cells.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li> <li class="seamTextUnorderedListItem">Zotatifin is an experimental targeted therapy called a elF4A inhibitor. Blocking elF4A may block cancer cell growth.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05101564' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/zotatifin-continues-to-demonstrate-favorable-activity-in-lung-and-breast-cancer-subtypes' target='_blank'>CancerNetwork: Zotatifin</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/view/will-there-be-a-resurgence-of-ki-67-scoring-in-breast-cancer-' target='_blank'>CURE: Will There Be a Resurgence of Ki-67 Scoring in Breast Cancer?</a> </li></ul>
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7

NEAREST SITE: 53 miles
Research Site
Santa Rosa,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05592483

Studying Outcomes of Enhertu ADC for Advanced HER2+ or HER2 Low Breast Cancer

A Multi-center, Multi-country Prospective Observational Study of Patients Initiating T-DXd in the First or Second Treatment Line for HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer Scientific Title

Purpose
To collect patient reported outcomes (PRO) from people receiving trastuzumab deruxtecan (T-DXd, Enhertu®) antibody drug conjugate (ADC).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low breast cancer who are planning to receive trastuzumab deruxtecan (T-DXd, Enhertu®) as their first or second line of therapy for advanced disease. You must have received anti-HER2 targeted therapy or 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 complete the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Symptom diary</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A patient reported outcome (PRO) is information reported during a clinical trial by a person with breast cancer without interpretation by a doctor or anyone else.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®) is an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®)'s antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/ISH-.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05592483' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (T-DXd, Enhertu®)</a> </li></ul>
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8

NEAREST SITE: 171 miles
Carson Tahoe Regional Medical Center
Carson City,NV

VISITS: Coincides with routine care

PHASE: NA

NCT ID: NCT04314401

NCI Cancer Moonshot Biobank for Stage III-IV Breast Cancer

Cancer Moonshot Biobank Research Protocol Scientific Title

Purpose
To collect tissue samples, blood samples, and medical information from people with breast cancer to study how cancer changes over time and during treatment.
Who is this for?
People with stage III or stage IV (metastatic) breast cancer who are receiving or planning to receive 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 provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tissue and blood samples before, during, and after treatment</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Collecting tissue samples, blood samples, and medical information over time may help researchers better understand resistance to treatment, changes in genes, and other factors about how cancer responds to treatment.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people 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/NCT04314401' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://moonshotbiobank.cancer.gov/' target='_blank'>National Cancer Institute: Cancer Moonshot Biobank</a> </li></ul>
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9

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

VISITS: 1 visit every 6 months (coincides with standard follow up visits), for up to 7 years

PHASE: II

NCT ID: NCT04567420

A ctDNA Blood Test to Screen for Recurrence for Stage II-III ER+, HER2- Breast Cancer

A Randomized Phase II Trial Of Circulating Tumor DNA-Guided Second Line Adjuvant Therapy For High Residual Risk, Stage II-III, Hormone Receptor Positive, HER2 Negative Breast Cancer Scientific Title

Purpose
To study the anti-cancer activity, safety, and side effects of using a ctDNA blood test to guide treatment decisions in people who are taking anti-hormone therapy after surgery.
Who is this for?
People with stage II or stage III estrogen-receptor positive (ER+), HER2-negative (HER2-) breast cancer. You must be taking an anti-hormone therapy after surgery, and your cancer must be considered at high risk for recurrence (coming back). See below for the definition of high-risk.    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">ctDNA blood test, every 4 to 6 months, for up to 7 years</li> </ul> <p class="seamTextPara"> If a ctDNA blood test is positive, 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">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your current anti-hormone therapy (an aromatase inhibitor or tamoxifen)</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 Palbociclib (Ibrance®) and Fulvestrant (Faslodex®).</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> <li class="seamTextUnorderedListItem">Fulvestrant is a type of anti-estrogen therapy called a SERD (selective estrogen receptor degrader). It is approved to treat some people with advanced HR+ breast cancer.</li> <li class="seamTextUnorderedListItem">For this trial, some of the definitions of cancer at high risk of recurrence include: </li> <li class="seamTextUnorderedListItem">Cancer found in 4 or more lymph nodes, or </li> <li class="seamTextUnorderedListItem">A tumor 5 cm or larger, or</li> <li class="seamTextUnorderedListItem">Cancer found in 1 to 3 lymph nodes, and your tumor was at least 3 cm, or grade 3 or, your Oncotype DX score was greater than 26, MammaPrint score was high risk, EndoPredict was greater than 4, or Prosigna score was greater than 60.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04567420' target='_blank'>ClinicalTrials.gov</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://www.natera.com/oncology/signatera-advanced-cancer-detection/' target='_blank'>Natera ctDNA Test Information Page: Signature</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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10

NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA

VISITS: 1 visit every 1-2 months

PHASE: III-IV

NCT ID: NCT05376878

PET/MRI Scan to Determine Response to Treatment for People with Metastatic HER2+ Breast Cancer with Brain or Leptomeninges Metastasis

Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan Scientific Title

Purpose
To find HER2+ breast cancer that has spread to the brain and predict response to treatment with trastuzumab deruxtecan (Enhertu®), an antibody drug conjugate (ADC).
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that has spread to the brain or leptomeninges (brain or leptomeningeal metastasis) who are planning to receive treatment with trastuzumab deruxtecan (Enhertu®).    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">Trastuzumab (Herceptin®), by IV, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">64Cu-DOTA-trastuzumab, by IV, 1 time</li> <li class="seamTextUnorderedListItem">PET/MRI scan, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain MRI scan, every 1.5 months for 6 months, then every 2 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">64Cu-DOTA-trastuzumab is an experimental tracer that detects cancer cells during imaging scans.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive tracer to look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy.</li> <li class="seamTextUnorderedListItem">The results of your PET/MRI scan will find the cancer in your brain and may predict your response to treatment.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a type of anti-HER2 targeted therapy used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05376878' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cedars-sinai.org/programs/imaging-center/exams/nuclear-medicine/pet-mri.html' target='_blank'>Cedars-Sinai: PET/MRI Scan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab deruxtecan (Enhertu®)</a> </li></ul>
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11

NEAREST SITE: 375 miles
Knowledge Research Center
Orange,CA

VISITS: 2 times within 6 months, then 3 times within 2 years

PHASE: NA

NCT ID: NCT04638751

Stool and Blood Sample Bank to Develop New Treatments for Triple Negative Breast Cancer

ARGONAUT: Development and Analysis of a Blood and Stool Sample Bank for Cancer Patients, Enabling the Systematic Study of the Effect of Gut Microbiomes on Response to Treatment Scientific Title

Purpose
To collect stool and blood samples to study gut microbiomes, study cancer biomarkers, and develop new treatments.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer planning to receive their next treatment.    Full eligibility criteria
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  • <p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stool and blood samples, 2 times within 6 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stool samples will be used to study your gut microbiome, which are the microorganisms that live in your digestive system. Drugs that target your microbiome may be helpful to treat cancer.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people 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/NCT04638751' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healthline.com/nutrition/gut-microbiome-and-health' target='_blank'>Healthline: Gut Microbiome</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aiche.org/resources/publications/cep/2020/october/developing-precision-microbiome-medicines' target='_blank'>American Institute of Chemical Engineers: Developing Precision Microbiome Medicines</a> </li></ul>
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12

NEAREST SITE: 507 miles
King Regional Medical Center
Kingman,AZ

VISITS: 2 visits

PHASE: II

NCT ID: NCT05710328

DIRECT: PET/CT Scan to Predict Response to Chemotherapy Before Surgery for Stage II-III HER2 Positive Breast Cancer

Interim FDG-PET/CT for PreDIcting REsponse of HER2+ Breast Cancer to Neoadjuvant Therapy: DIRECT Trial Scientific Title

Purpose
To use of PET/CT scans with FDG to help doctors decide if a person needs more or less neoadjuvant (before surgery) chemotherapy to get the best response.
Who is this for?
People with stage II or stage III newly diagnosed HER2 positive (HER2+) breast cancer who have not yet received treatment.    Full eligibility criteria
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  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PET/CT scan with FDG, by IV, 2 times</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FDG is a radioactive tracer that is given in a vein before PET/CT scans to help identify areas of active cancer.</li> <li class="seamTextUnorderedListItem">PET and and CT scans are imaging techniques that make detailed, computerized pictures of areas inside the body.</li> <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 computed tomography (CT) scan produces body pictures created by x-ray energy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05710328' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ecog-acrin.org/clinical-trials/ea1211-direct-breast-cancer/' target='_blank'>ECOG-ACRIN Cancer Research Group: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/certain-pet-scan-detects-recurrence-better' target='_blank'>Breastcancer.org: FDG PET/CT Scan</a> </li></ul>
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13

NEAREST SITE: 533 miles
OHSU Knight Cancer Institute
Portland,OR

VISITS: 4 visits

PHASE: NA

NCT ID: NCT05704062

MRI Scans to Predict and Evaluate Response to Chemotherapy Before Surgery for People with Stage I-III Breast Cancer

Multi-Functional Magnetic Resonance Imaging Modalities for Assessment of Breast Cancer Response to Neoadjuvant Chemotherapy Scientific Title

Purpose
To study if MRI scans can earlier and more accurately predict and evaluate response to neoadjuvant (before surgery) chemotherapy.
Who is this for?
People with stage I, stage II, or stage III breast cancer who are planning to receive neoadjuvant (before surgery) chemotherapy.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI scans, 4 times over the course of chemotherapy</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment, like chemotherapy, before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies. </li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan is a type of scan that uses a very strong magnet and no radiation or x-ray energy to take very detailed pictures of parts of the body.</li> <li class="seamTextUnorderedListItem">MRI scans are often used as standard of care to take pictures of breast tumor(s) before and after chemotherapy treatment to measure the tumor size changes in response to treatment and plan for surgery.</li> <li class="seamTextUnorderedListItem">MRI scans are used because the images it takes are very clear and the borders of the tumor can be measured very accurately. However the tumor size alone is often not a good early indicator of whether or not the tumor responds to treatment.</li> <li class="seamTextUnorderedListItem">You will receive 4 MRI scans: before treatment, after the first treatment cycle, midway through treatment, and at the end of treatment.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05704062' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/breast-mri' target='_blank'>Breastcancer.org: Breast MRI</a> </li></ul>
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14

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

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT04450706

Biopsy to Select Treatment for Metastatic HER2-Negative Breast Cancer

FORESEE: Functional Precision Oncology for Metastatic Breast Cancer: a Feasibility Trial Scientific Title

Purpose
To study the ability of genomic testing and drug screening of tumor tissue to select your next treatment(s).
Who is this for?
People with metastatic (stage IV) HER2 negative (HER2-) breast cancer. If your cancer is triple negative (ER, PR-, HER2-), you must not have received treatment for metastatic disease.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy to collect tumor tissue</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor tissue collected during the biopsy will be used for genomic testing and drug screening.</li> <li class="seamTextUnorderedListItem">Genomic testing identifies DNA in your tumor cells.</li> <li class="seamTextUnorderedListItem">Drug screening tests the response of your tumor cells to potential treatments.</li> <li class="seamTextUnorderedListItem">The results from the genomic testing and drug screening may be used by your doctor to choose your next treatment(s).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04450706' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancercenter.com/treatment-options/precision-medicine/advanced-genomic-testing' target='_blank'>Cancer Treatment Centers of America: Genomic Testing</a> </li></ul>
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15

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

VISITS: Coincides with surgery

PHASE: II

NCT ID: NCT05464082

Predict, Prevent, and Treat Early Metastatic Recurrence of HR Low, HER2-/HER2 Low or Triple Negative Breast Cancer

Towards Functional Precision Oncology to Predict, Prevent, and Treat Early Metastatic Recurrence of Triple Negative Breast Cancer Scientific Title

Purpose
To study ways to predict, prevent, and treat early metastatic recurrence.
Who is this for?
People with stage I, stage II, or stage III hormone receptor (ER and/or PR) low, HER2 negative (HER2-) or HER2 low or triple negative (ER-, PR-, HER2-) breast cancer. You must have not yet received treatment and be planning to receive surgery and chemotherapy.    Full eligibility criteria
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  • <p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor samples</li> <li class="seamTextUnorderedListItem">Blood tests</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Precision oncology is treatment based on specific information from your tumor.</li> <li class="seamTextUnorderedListItem">The tumor samples will be used to complete tests to determine which treatments may be most effective.</li> <li class="seamTextUnorderedListItem">If your cancer comes back (recurrence) after surgery and chemotherapy, your doctor will receive information to help make treatment decisions.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+ and ISH-.</li> <li class="seamTextUnorderedListItem">In this trial, hormone receptor (HR) low is defined as 1-10% of cells that are ER+ and PR+.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05464082' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/precision-medicine-breast-cancer/about/pac-20385240' target='_blank'>Mayo Clinic: What is Precision Oncology?</a> </li></ul>
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16

NEAREST SITE: 682 miles
Fred Hutchinson Cancer Center
Seattle,WA

VISITS: 1 visit every 3 months

PHASE: II

NCT ID: NCT05721248

Safely Stopping Anti-HER2 Targeted Therapy for People with Advanced HER2+ Breast Cancer Who Are Exceptional Responders

The STOP-HER2 Trial: A Phase 2 Study of Stopping Trastuzumab - Outcomes in Patients With HER2+ Metastatic Breast Cancer Scientific Title

Purpose
To study if anti-HER2 targeted therapy can be safely stopped in people with HER2 positive metastatic breast cancer that have had an exceptional response to treatment.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer that has not progressed in the last 3 years during treatment with any anti-HER2 targeted therapy as a first line of therapy for advanced disease.    Full eligibility criteria
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  • <p class="seamTextPara"> You can choose to participate in 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Choose to Continue Anti-HER2 Treatment</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Continue anti-HER2 treatment</li> <li class="seamTextUnorderedListItem">Visits, monthly for 2-3 months, then every 3 months</li> <li class="seamTextUnorderedListItem">Imaging scans, every 3 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Choose to Stop Anti-HER2 Treatment</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stop anti-HER2 treatment</li> <li class="seamTextUnorderedListItem">Visits, monthly for 2-3 months, then every 3 months</li> <li class="seamTextUnorderedListItem">Imaging scans, every 3 months</li> </ul> <p class="seamTextPara"> followed 1 year later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stop treatment indefinitely if no progression</li> <li class="seamTextUnorderedListItem">Imaging scans (surveillance), every 3-6 months for 10 years</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You can choose which group you would like to participate in.</li> <li class="seamTextUnorderedListItem">Exceptional response is considered cancer progression being controlled for 3 years or more since starting anti-HER2 targeted treatment.</li> <li class="seamTextUnorderedListItem">This study is also studying whether blood samples that may contain traces of DNA from cancer, known as circulating tumor DNA (ctDNA), are able to help identify which people can successfully stop treatment without a change in their cancer.</li> <li class="seamTextUnorderedListItem">If you have estrogen receptor positive (ER+) breast cancer, you will continue hormone therapy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05721248' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/clinical-trials2/detail/22-655/' target='_blank'>Dana-Farber Cancer Institute: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/mbc-exceptional-responder/' target='_blank'>Metastatic Trial Talk: Why Do Some People Have an Exceptional Response When Being Treated for MBC?</a> </li></ul>
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17

NEAREST SITE: 941 miles
University of Colorado Denver
Aurora,CO

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT01503190

Immune System Response to Breast Cancer in Women Under Age 50

A Translational Study of the Interactions Between Prior Pregnancy and the Biologic Subtype of Breast Cancer in Defining the Cancer: Host Immunologic Interaction Scientific Title

Purpose
To determine how the immune system responds to different types of tumors or to tumors that develop during or after a pregnancy. Some of the breast cancer tissue collected in this study will be used to create models that develop and test new drug treatments.
Who is this for?
Women with any stage of breast cancer who are 50 years or younger    Full eligibility criteria
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  • What's being studied?
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  • <p class="seamTextPara"> All participants will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tissue, blood and urine samples, if recently diagnosed</li> <li class="seamTextUnorderedListItem">Tissue donation only, if enrolled after treatment has begun or has ended</li></ul>
  • <p class="seamTextPara"> Researchers are interested in learning more about the role the immune system plays in cancer. </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This study is looking specifically at the level of immune suppression seen in breast cancer that occurs in women under age 50.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01503190' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/tips/immune/' target='_blank'>BreastCancer.org: Understanding Your Immune System</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.youngsurvival.org/' target='_blank'>Young Survival Coalition</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ucdenver.edu/academics/colleges/medicalschool/departments/medicine/MedicalOncology/faculty/Pages/VirginiaFBorges,MD.aspx' target='_blank'>Study PI: Virginia F. Borges, MD</a> </li></ul>
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18

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04849364

Chemotherapy, Immunotherapy, and/or Targeted Therapy to Prevent Recurrence of Triple Negative Breast Cancer That is ctDNA Positive

A Phase II Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer (PERSEVERE) Scientific Title

Purpose
To study if chemotherapy, immunotherapy, and/or targeted therapy after neoadjuvant chemotherapy and surgery helps prevent recurrence.
Who is this for?
People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2- or HER2 low) breast cancer that is ctDNA positive. You must have received chemotherapy before surgery (neoadjuvant). If you received a lumpectomy or partial mastectomy, you must have also received radiation.    Full eligibility criteria
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  • How can I learn more?
  • <p class="seamTextPara"> You will be assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks for 7 months</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off, 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib (GDC-0077), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off, 6 months</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks for 7 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), 6 months</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks for 7 months</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off, 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will be assigned to a group based on ctDNA testing and genetic testing results.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small pieces of cancer cell DNA in the bloodstream.</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) and pembrolizumab (Keytruda®) are a type of immunotherapy called a PD-1/PD-L1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1/PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Inavolisib (GDC-0077) is an experimental targeted therapy called a PI3K inhibitor. If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, which allows cancer cells to grow.</li> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a type of targeted therapy called a PARP inhibitor. It prevents the PARP protein from repairing damaged DNA in tumor cells.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 negative is defined as IHC 0 to 2+.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04849364' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cancer.iu.edu/patients/research-explained/breast/persevere.html' target='_blank'>Indiana University: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li></ul>
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19

NEAREST SITE: 1499 miles
The University of Kansas Cancer Center - Overland Park
Overland Park,KS

VISITS: 1 visit every 2-3 weeks for 3-4.5 months

PHASE: II

NCT ID: NCT05645380

Chemoimmunotherapy Before Surgery for Women with Stage I-III Triple Negative Breast Cancer

Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC Scientific Title

Purpose
To study if the number of immune cells in and around tumors impacts tumor response to neoadjuvant (before surgery) chemoimmunotherapy and can be used to personalize the type and amount of neoadjuvant chemoimmunotherapy.
Who is this for?
Women 18-70 years old with stage I, stage II, or some stage III triple negative (ER-, PR-, HER2-) breast cancer who have not yet received 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 based on your situation: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: High/Intermediate Number of Immune Cells</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for 3-4.5 months</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV, every 3 weeks for 3-4.5 months</li> <li class="seamTextUnorderedListItem">Pembrolizumb (Keytruda®), by IV, every 3 weeks for 3-4.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Low Number of Immune Cells</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Pembrolizumb (Keytruda®), by IV, every 3 weeks for 3 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), by IV, every 2-3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 2-3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Pembrolizumb (Keytruda®), by IV, every 2-3 weeks for 3 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemoimmunotherapy is chemotherapy combined with immunotherapy.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), docetaxel (Taxotere®), doxorubicin (Adriamycin®), and cyclophosphamide (Cytoxan®) are chemotherapy drugs commonly used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Triple negative breast cancer (TNBC) with more immune system cells in and around the tumor are more sensitive to chemoimmunotherapy and have better outcomes.</li> <li class="seamTextUnorderedListItem">Imaging is often used during the course of neoadjuvant chemoimmunotherapy to monitor how the disease is responding to treatment.</li> <li class="seamTextUnorderedListItem">Tumor disappearance seen by imaging scans after chemoimmunotherapy usually means that the tumor will have completely disappeared by surgery.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05645380' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/search?search=carboplatin' target='_blank'>Breastcancer.org: Carboplatin (Paraplatin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxotere' target='_blank'>Breastcancer.org: Docetaxel (Taxotere®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/adriamycin' target='_blank'>Breastcancer.org: Doxorubicin (Adriamycin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/cytoxan' target='_blank'>Breastcancer.org: Cyclophosphamide (Cytoxan®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
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20

NEAREST SITE: 1615 miles
Mayo Clinic in Rochester
Rochester,MN

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT06055881

Radiation to Delay Treatment Changes and CTCs to Guide Treatment Options for People with Metastatic Breast Cancer

Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy (BOSS) Scientific Title

Purpose
To study if radiation therapy can delay treatment changes and if circulating tumor cells (CTCs) can help guide treatment options.
Who is this for?
Women with stage IV (metastatic) breast cancer who have been receiving their first line of therapy for metastatic disease for at least 1 year or have been receiving their second or later line of therapy for at least 6 months. You must have 1-3 sites of oligoprogressive disease that have not received radiation and must not have triple negative 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">Blood tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (also called stereotactic radiosurgery or stereotactic body radiotherapy) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Circulating tumor cells (CTCs) are cancer cells from a tumor that circulate in the bloodstream.</li> <li class="seamTextUnorderedListItem">In this trial, CTCs may be used to help you and your doctor guide treatment options.</li> <li class="seamTextUnorderedListItem">Oligoprogressive disease refers to progression of only a few sites of metastasis.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06055881' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/clinical-trials/cls-20555625' target='_blank'>Mayo Clinic: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/sbrt/pyc-20446794' target='_blank'>Mayo Clinic: Stereotactic Body Radiotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/20071218' target='_blank'>Breastcancer.org: Circulating Tumor Cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/ctc/' target='_blank'>Metastatic Trial Talk: Circulating Tumor Cell Testing</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oligometastatic-breast-cancer/' target='_blank'>Metastatic Trial Talk: What is Oligometastatic Breast Cancer?</a> </li></ul>
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21

NEAREST SITE: 1615 miles
Mayo Clinic in Rochester
Rochester,MN

VISITS: Coincides with radiation therapy

PHASE: NA

NCT ID: NCT04308720

Studying Changes to ctDNA During Radiation Therapy in DCIS and Stage I-IV Breast Cancer

Circulating Tumor DNA and Immunophenotyping as Potential Biomarkers in Patients Undergoing Regional Nodal Irradiation for Breast Cancer Scientific Title

Purpose
To study how radiation therapy affects ctDNA and the immune system and if ctDNA can predict disease progression.
Who is this for?
People diagnosed with DCIS, stage I, stage II, or stage III breast cancer who will receive radiation therapy after surgery. You may also enroll if you have metastatic (stage IV) breast cancer with no more than three metastases that you plan to treat with radiation therapy.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following during your radiation therapy: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draws and a ctDNA test, 3 or 4 times</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">Radiation therapy uses high-energy x-rays to kill tumor cells that remain after surgery. </li> <li class="seamTextUnorderedListItem">Researchers are studying if a test looking for ctDNA in the bloodstream before, during, and after radiation therapy can determine if there will be a recurrence (coming back) of a person's breast cancer or a progression of metastatic disease. </li> <li class="seamTextUnorderedListItem">Researchers are also studying if radiation therapy affects the ctDNA mutations.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04308720' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/clinical-trials/cls-20469371' target='_blank'>Mayo Clinic Study Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/genetics/understanding/testing/circulatingtumordna/' target='_blank'>MedLinePlus: What is Circulating Tumor DNA and How is it Used to Diagnose and Manage Cancer</a> </li></ul>
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22

NEAREST SITE: 1615 miles
Mayo Clinic in Rochester
Rochester,MN

VISITS: Coincides with biopsy

PHASE: NA

NCT ID: NCT06322602

Ommaya Reservoir Placement During Biopsy to Study Biomarkers for People With Brain Metastases

Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection Scientific Title

Purpose
To study the ability of an Ommaya reservoir placed during a biopsy to collect biomarkers over time.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis).    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">Place Ommaya reservoir during biopsy</li> <li class="seamTextUnorderedListItem">Lumbar puncture</li> <li class="seamTextUnorderedListItem">CT scan</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ommaya reservoirs are very small plastic devices put under the scalp to collect cerebrospinal fluid (CSF), the fluid or liquid surrounding your brain and spinal cord.</li> <li class="seamTextUnorderedListItem">A biomarker indicates the severity or presence of a disease.</li> <li class="seamTextUnorderedListItem">Identifying biomarkers in CSF may help monitor tumor growth and response to treatment.</li> <li class="seamTextUnorderedListItem">In the future, these biomarkers may be used to help determine what treatments could be most effective and how well a tumor has responded to prior treatment.</li> <li class="seamTextUnorderedListItem">Having an Ommaya reservoir placed during a biopsy may allow for long-term biomarker collection.</li> <li class="seamTextUnorderedListItem">A lumbar puncture, also known as a spinal tap, is a procedure to collect a sample of CSF.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06322602' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
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23

NEAREST SITE: 1615 miles
Mayo Clinic
Rochester,MN

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04570956

Tamoxifen Hormone Therapy for Women With Atypical Hyperplasia or LCIS

A Phase IIB Randomized Trial of Oral Tamoxifen vs. Topical 4-hydroxytamoxifen Gel vs. Control in Women With Atypical Hyperplasia or Lobular Carcinoma In Situ Scientific Title

Purpose
To study changes in breast tissue after treatment with tamoxifen by mouth or gel.
Who is this for?
Women with atypical hyperplasia or lobular carcinoma in situ (LCIS).    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 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for tamoxifen (Nolvadex®), by mouth, daily</li> <li class="seamTextUnorderedListItem">4-hydroxytamoxifen (TamGel®), gel rubbed on the breast, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for tamoxifen (Nolvadex®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Placebo for 4-hydroxytamoxifen (TamGel®), gel rubbed on the breast, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 biopsies</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li> <li class="seamTextUnorderedListItem">4-hydroxytamoxifen (TamGel®) is a gel version of tamoxifen.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04570956' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/diseases-conditions/breast-cancer/in-depth/breast-cancer/art-20045353#:~:text=Tamoxifen%20is%20used%20to%20reduce,score%20is%20greater%20than%201.7%25.' target='_blank'>Mayo Clinic: Tamoxifen for Breast Cancer Prevention</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li></ul>
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24

NEAREST SITE: 1621 miles
MD Anderson in The Woodlands
Conroe,TX

VISITS: Coincides with routine care

PHASE: NA

NCT ID: NCT02276443

Tumor Testing Before Treatment for Stage I-III Triple Negative Breast Cancer

Improving Outcomes in Triple-Negative Breast Cancer Using Molecular Triaging and Diagnostic Imaging to Guide Neoadjuvant Therapy ARTEMIS MDACC Breast Moonshot Initiative) Scientific Title

Purpose
To study if tumor testing before treatment improves treatment response.
Who is this for?
People with newly diagnosed stage I, stage II, or stage III triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer who have not yet received 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 receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biomarker and molecular tumor testing</li> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> <li class="seamTextUnorderedListItem">Ultrasound, 4 times</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your choice of standard of care treatment or clinical trial based on testing results</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment, like chemotherapy, before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li> <li class="seamTextUnorderedListItem">Studies suggest molecular testing of tumors can help guide treatment options.</li> <li class="seamTextUnorderedListItem">This study will compare tumor response of women whose treatment is guided by tumor testing results to those of women whose treatment is chosen without tumor testing.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02276443' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2014-0185.html' target='_blank'>MD Anderson Cancer Center: ARTEMIS Trial Information Page</a> </li></ul>
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25

NEAREST SITE: 1644 miles
O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center
Houston,TX

VISITS: Coincides with routine care

PHASE: II

NCT ID: NCT05020860

Predicting the Amount of Tumor Remaining After Surgery in People with Newly Diagnosed Stage I-III Breast Cancer

A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer Scientific Title

Purpose
To study if clinical response (the amount a tumor shrinks based on imaging or a physical exam) predicts pathologic response (the amount of tumor remaining after surgery).
Who is this for?
People with newly diagnosed stage I, stage II, or stage III estrogen receptor positive (ER+); HER2 positive (HER2+); or triple negative (ER-, PR-, HER2-) breast cancer who have not yet received 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 receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care treatment based on tumor type</li> <li class="seamTextUnorderedListItem">ctDNA tests</li> <li class="seamTextUnorderedListItem">MRI scan, 2 times (for people with triple negative breast cancer)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A pathologic complete response (pCR) means that there are no cancer cells identified in the tissue removed at surgery.</li> <li class="seamTextUnorderedListItem">All treatment in this study is standard of care.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) is DNA from a tumor circulating in the bloodstream.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05020860' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/pathologic-complete-response' target='_blank'>National Cancer Institute: Pathologic Complete Response</a> </li></ul>
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26

NEAREST SITE: 1678 miles
UW Carbone Cancer Center
Madison,WI

VISITS: 2 visits within 1 month

PHASE: II

NCT ID: NCT06067503

Biomarkers to Detect Resistance to Hormone Therapy for Advanced HR+, HER2- Lobular Breast Cancer

Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer Scientific Title

Purpose
To identify possible biomarkers of response to hormone therapy for advanced lobular breast cancer.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2-) lobular breast cancer (LBC) who are planning to receive hormone therapy.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PET/CT scans with 18F-FFNP, by IV, 2 times within 1 month</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times within 1 month</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biomarkers are genes, molecules, or other features present in a person, including in a person’s tumor, that tell doctors something about a person’s health condition.</li> <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 study is 18F-FFNP.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy. MRI scans study the blood vessels in the tumor. PET/CT scans study if the tumor cells are growing.</li> <li class="seamTextUnorderedListItem">The blood samples will be used to conduct DNA and circulating tumor cell (CTC) testing.</li> <li class="seamTextUnorderedListItem">Circulating tumor cells (CTCs) are cancer cells from a tumor that circulate in the bloodstream.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06067503' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/biomarker-testing-cancer-treatment' target='_blank'>National Cancer Institute: Biomarker Testing</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/pet-scans' target='_blank'>Breastcancer.org: PET Scans</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/ct-scan' target='_blank'>Breastcancer.org: CT Scans</a> </li></ul>
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27

NEAREST SITE: 1734 miles
Washington University School of Medicine
Saint Louis,MO

VISITS: Coincides with surgical appointments

PHASE: NA

NCT ID: NCT00353483

Studying Disseminated Cancer Cells Before and After Chemotherapy

Effect of Neoadjuvant Chemotherapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells Scientific Title

Purpose
To compare the tumor markers seen on DTCs detected prior to chemotherapy to the tumor markers seen on any DTCs present after chemotherapy.
Who is this for?
People with stage II, 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"> Breast cancer tissue, peripheral blood, and bone marrow will be collected 3-4 times: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">During surgery for a sentinel lymph node biopsy or portacath placement</li> <li class="seamTextUnorderedListItem">During breast cancer surgery (if surgery occurs)</li> <li class="seamTextUnorderedListItem">At one year</li> <li class="seamTextUnorderedListItem">If metastatic disease develops</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Single tumor cells or small groups of tumor cells that are found in the lymph or blood are often referred to as disseminated tumor cells (DTCs). </li> <li class="seamTextUnorderedListItem">Chemotherapy that is given before surgery may not kill all cancer cells. </li> <li class="seamTextUnorderedListItem">DTCs that are not killed by chemotherapy are believed to have a unique set of tumor marker proteins.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT00353483' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://scholar.google.com/scholar?hl=en&as_sdt=0%2C47&q=DTC+tumor+markers+breast+cancer&btnG=' target='_blank'>Google Scholar: DTC tumor markers breast cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/10470239' target='_blank'>PubMed Abstract: Disseminated tumor cells versus micrometastasis: definitions and problems</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5423226/' target='_blank'>Molecular Oncology: Circulating and disseminated tumor cells: harbingers or initiators of metastasis?</a> </li></ul>
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28

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

VISITS: 9 visits within 6 months, then every 3 months for 2.5 years

PHASE: NA

NCT ID: NCT04968964

DiviTum Blood Test to Determine Additional Testing for People with Metastatic HR+, HER2- Breast Cancer

TK IMPACT: Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing: Physician Decision Impact Study Scientific Title

Purpose
To study whether the DiviTum® blood test affects your doctor's decision to conduct additional tumor tests or imaging.
Who is this for?
People with metastatic (stage IV) hormone positive (HR+), HER2 negative (HER2-) breast cancer receiving or planning to receive their first line of therapy for metastatic disease with hormone therapy and a CDK 4/6 inhibitor at Washington University School of Medicine Siteman 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">Blood tests, every 2-4 weeks for 6 months, then every 3 months for 2.5 years</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The DiviTum® TKa test measures TK1 activity in your blood, which may indicate the rate your cancer is growing and the need for additional tests.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04968964' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://biovica.com/divitum/' target='_blank'>Biovica: DiviTum® Test</a> </li></ul>
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29

NEAREST SITE: 1761 miles
University of Wisconsin School of Medicine and Public Health
Madison,WI

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04573231

Evaluating PSMA Expression to Determine Response to Anti-Androgen Therapies for Metastatic HER2-, AR+ Breast Cancer

Evaluation of Prostate Specific Membrane Antigen (PSMA) in HER2-negative, Androgen Receptor (AR)-Positive Metastatic Breast Cancer With 18F-DCFPyL PSMA-based PET/CT Scientific Title

Purpose
To evaluate prostate specific membrane antigen (PSMA) expression in breast cancer to determine people most likely to benefit from anti-androgen therapies.
Who is this for?
People with metastatic (stage IV) HER2 negative (HER2-), androgen receptor positive (AR+) 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">PET/CT scan with 18F-DCFPyL</li> <li class="seamTextUnorderedListItem">Circulating tumor cells (CTC) test</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Prostate specific membrane antigen (PSMA) expression may correlate with resistance to anti-androgen therapies, which has been documented in prostate cancer.</li> <li class="seamTextUnorderedListItem">Evaluating PSMA expression may be used to select people most likely to benefit from anti-androgen therapies, such as bicalutamide (Casodex®), in future clinical trials.</li> <li class="seamTextUnorderedListItem">18F-DCFPyL is a tracer that is used to visualize PSMA expression during imaging scans.</li> <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 computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">Circulating tumor cells (CTCs) are breast cancer cells that leave the tumor and move through the bloodstream.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PSMA, AR</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04573231' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/news/psma-new-target-prostate-cancer-treatment' target='_blank'>Memorial Sloan Kettering Cancer Center: PSMA</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://metastatictrialtalk.org/from-the-experts/ctc/#:~:text=A%20circulating%20tumor%20cell%20(CTC,test%20for%20metastatic%20breast%20cancer.' target='_blank'>Metastatic Trial Talk: Circulating Tumor Cell Testing</a> </li></ul>
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30

NEAREST SITE: 1849 miles
Orchard Healthcare Research Inc.
Skokie,IL

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05935384

Guardant360 Blood Test to Measure Treatment Response for People with Advanced Breast Cancer

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation Scientific Title

Purpose
To collect information to develop a Guardant360 blood test that can measure treatment response.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) who have received 0-1 lines of therapy for advanced disease.    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">Guardant360 blood test</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Guardant360 is a blood test that identifies genomic biomarkers and mutations to help make treatment decisions.</li> <li class="seamTextUnorderedListItem">This trial is collecting information to develop a future version of Guardant360 that can measure treatment response.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05935384' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/tumor-marker-tests' target='_blank'>Breastcancer.org: Breast Cancer Biomarkers and Biomarker Tests</a> </li><li class='seamTextUnorderedListItem'><a href='https://guardanthealth.com/products/tests-for-patients-with-advanced-cancer/' target='_blank'>Guardant Health: Guardant360 Test Information Page</a> </li></ul>
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31

NEAREST SITE: 1857 miles
University of Chicago Medical Center
Chicago,IL

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT04541381

Pharmacogenomics Testing to Make Chemotherapy Dosing Decisions for People with Breast Cancer

PhOCus: Implementation of Pharmacogenomic Testing in Oncology Care Scientific Title

Purpose
To study if pharmacogenomics testing, a type of genetic testing, helps doctors make chemotherapy dosing decisions and decreases chemotherapy side effects.
Who is this for?
People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive chemotherapy. You must be receiving care at The University of Chicago 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 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">Receive chemotherapy</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Provide DNA samples for pharmacogenomics testing, after chemotherapy treatment</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Provide DNA samples for pharmacogenomics testing</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive chemotherapy based on pharmacogenomics testing results</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doctors leading the study will collect your genetic information using pharmacogenomics/genotyping, a type of genetic testing.</li> <li class="seamTextUnorderedListItem">Pharmacogenomics is the study of how the differences in our genes can affect our unique response to medications.</li> <li class="seamTextUnorderedListItem">If you are in Group 2, your doctor will use your test results to make dosing decisions/changes to your chemotherapy treatment.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04541381' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://nigms.nih.gov/education/fact-sheets/Pages/pharmacogenomics.aspx#:~:text=Pharmacogenomics%20(sometimes%20called%20pharmacogenetics)%20is,best%20suited%20for%20each%20person.' target='_blank'>National Institutes of Health: Pharmacogenomics</a> </li></ul>
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32

NEAREST SITE: 1946 miles
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis,IN

VISITS: 1 visit

PHASE: NA

NCT ID: NCT06084676

Tissue Samples to Predict Response to Immunotherapy for Stage I-IV Breast Cancer

Organoid Model Predictive of Response to Immunotherapies Scientific Title

Purpose
To use biopsy samples to predict response to immunotherapy.
Who is this for?
People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive immunotherapy.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy sample</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy tissue can be used to make organoids.</li> <li class="seamTextUnorderedListItem">Organoids are tissue samples used in the lab to test and predict response to treatment, such as immunotherapy.</li> <li class="seamTextUnorderedListItem">In this trial, the organoids will receive the same immunotherapy that you are receiving.</li> <li class="seamTextUnorderedListItem">Immunotherapies are drugs that help the immune system find, attack, and kill cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06084676' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.atcc.org/cell-products/cell-models/organoids#t=productTab&numberOfResults=24' target='_blank'>ATCC: What is an Organoid and How are Organoids Used in Cancer Research?</a> </li></ul>
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33

NEAREST SITE: 1958 miles
Vanderbilt University/Ingram Cancer Center
Nashville,TN

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05693766

Hormone Therapy or Chemotherapy with Genetic Testing for Metastatic HR+, HER2- Breast Cancer

Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT) Scientific Title

Purpose
To compare the safety, effects (good and bad), and anti-cancer activity of hormone therapy and capecitabine (Xeloda®) chemotherapy and use MammaPrint® and BluePrint tests to guide treatment decisions.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-), non-Luminal A breast cancer who have received treatment with an aromatase inhibitor or selective estrogen receptor modulator/downregulator (SERM/SERD) with a CDK4/6 inhibitor. You must not have received chemotherapy or more than 1 line of hormone therapy for advanced disease or have a PIK3CA 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 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">Physician's choice of hormone therapy</li> <li class="seamTextUnorderedListItem">Provide tissue samples for MammaPrint® and BluePrint tests </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 1 week on, 1 week off</li> <li class="seamTextUnorderedListItem">Provide tissue samples for MammaPrint® and BluePrint tests</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">MammaPrint® and BluePrint are genetic tests that use tumor samples to help guide treatment decisions.</li> <li class="seamTextUnorderedListItem">The tests will also be used to determine if certain mutations are potentially associated with resistance to therapy.</li> <li class="seamTextUnorderedListItem">Luminal A breast cancer is ER+, PR+, and HER2- with low Ki-67 levels, which controls how fast cancer cells grow. Luminal A cancers tend to grow more slowly.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05693766' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/molecular-subtypes' target='_blank'>Breastcancer.org: Molecular Subtypes of Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/genetic-testing' target='_blank'>Breastcancer.org: Genetic Testing for Breast Cancer</a> </li></ul>
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34

NEAREST SITE: 1959 miles
Vanderbilt University/Ingram Cancer Center
Nashville,TN

VISITS: 2 visits within up to 4 years

PHASE: NA

NCT ID: NCT05996432

MRI and PET Scans to Predict Resistance to Radiation for People with Metastatic Breast Cancer

Non-invasive, Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy Scientific Title

Purpose
To study whether a new type of MRI scan with PET scans can predict resistance to radiation.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive stereotactic radiation before brain 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">MRI scan, 2 times</li> <li class="seamTextUnorderedListItem">PET scan, 2 times</li> <li class="seamTextUnorderedListItem">Contrast agent, by IV, 2 times</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Resistance to radiation is a tumor coming back or growing after radiation, as seen on imaging scans.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <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 contrast agent, also called a tracer, is a radioactive substance that can look for and attach to cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05996432' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/diagnostics/22966-brain-mri' target='_blank'>Cleveland Clinic: Brain MRI</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/pet-scans' target='_blank'>Breastcancer.org: PET Scans</a> </li></ul>
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35

NEAREST SITE: 2013 miles
The University of Alabama at Birmingham
Birmingham,AL

VISITS: 3 visits within 6 months

PHASE: I-II

NCT ID: NCT04273555

PET/MRI Scans with FDG to Monitor Response to Treatment for Metastatic HER2+ Breast Cancer

Monitoring Early Response to Targeted Therapy in Stage IV Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Cancer Patients With Advanced Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI) Scientific Title

Purpose
To study if PET/MRI scans with FDG can monitor your response to treatment.
Who is this for?
Women with metastatic (stage IV) HER2 positive (HER2+) breast cancer who are planning to receive their first anti-HER2 targeted 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">18F-Fluorodeoxyglucose (FDG), by injection, 3 times within 6 months</li> <li class="seamTextUnorderedListItem">PET/MRI scans, 3 times within 6 months</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 magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">FDG is a tracer with a radioactive tag that is used to visualize cancer cells.</li> <li class="seamTextUnorderedListItem">PET/MRI scanning is a new imaging technique that combines PET and MRI scans into a single scan.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04273555' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cedars-sinai.org/programs/imaging-center/exams/nuclear-medicine/pet-mri.html' target='_blank'>Cedars-Sinai: PET/MRI Scan</a> </li></ul>
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36

NEAREST SITE: 2108 miles
Mount Carmel West Hospital
Columbus,OH

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT03536897

Radiation During Breast Cancer Surgery in Women Age 65 and Older

Intraoperative Radiation Therapy (IORT) Following Breast Conserving Surgery for Early Stage Breast Cancer Registry Scientific Title

Purpose
To develop a registry that will allow researchers to study the 5-year risk of a local breast cancer recurrence after intraoperative radiation therapy (IORT).
Who is this for?
Women age 65 or older with stage II or stage III low- risk breast cancer who will be treated with partial mastectomy (lumpectomy) and radiation during 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">IORT (Intraoperative radiation), during surgery</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Intraoperative radiation therapy (IORT) is given right after the tumor has been removed while you are still in the operating room.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03536897' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/intraoperative-radiation-therapy/about/pac-20385150' target='_blank'>Mayo Clinic: Intraoperative radiation therapy (IORT)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tricitymed.org/2016/10/iort-breast-cancer-treatment-primer/' target='_blank'>Tricity Medicine: IORT as Breast Cancer Treatment: A Primer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.uptodate.com/contents/overview-of-the-approach-to-early-breast-cancer-in-older-women' target='_blank'>UpToDate: Overview of the approach to early breast cancer in older women</a> </li></ul>
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37

NEAREST SITE: 2139 miles
Emory University/Winship Cancer Institute
Atlanta,GA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05877859

Response to Chemo and Immunotherapy Before Surgery for Women with Stage II-III Triple Negative Breast Cancer

Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab Scientific Title

Purpose
To study the immune response to treatment with standard of care chemotherapy given with the immunotherapy pembrolizumab (Keytruda®) before surgery.
Who is this for?
Women with newly diagnosed stage II or stage III triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer who have not yet received 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 receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care neoadjuvant (before surgery) chemotherapy with pembrolizumab (Keytruda®)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemo-immunotherapy is the combination of chemotherapy and immunotherapy.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+ and ISH-.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05877859' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/triple-negative' target='_blank'>Breastcancer.org: Treatment for Triple Negative Breast Cancer</a> </li></ul>
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38

NEAREST SITE: 2299 miles
Roswell Park Cancer Institute
Buffalo,NY

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT04526587

Studying Response to Treatment With CDK 4/6 Inhibitors in People with Stage I-IV HR+, HER2- Breast Cancer

The Roswell Park Ciclib Study: A Prospective Study of Biomarkers and Clinical Features of Advanced/Metastatic Breast Cancer Treated With CDK4/6 Inhibitors Scientific Title

Purpose
To study how breast cancer develops resistance to treatment with CDK 4/6 inhibitors and how to predict response to treatment with CDK 4/6 inhibitors.
Who is this for?
People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer or people with stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) node positive breast cancer. You must have completed treatment with or currently be receiving treatment with a CDK 4/6 inhibitor.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood, tissue, fluid, and biopsy samples</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your samples may be used to help your doctor make treatment decisions.</li> <li class="seamTextUnorderedListItem">Node positive breast cancer is breast cancer that has spread to the lymph nodes.</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04526587' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK 4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/?utm_medium=email&utm_source=subscribers&utm_campaign=Dec2022&utm_content=Email122022' target='_blank'>Metastatic Trial Search: CDK Inhibitors</a> </li></ul>
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39

NEAREST SITE: 2378 miles
UNC Lineberger Comprehensive Cancer Center
Chapel Hill,NC

VISITS: Coincides with routine care

PHASE: NA

NCT ID: NCT05978557

Tumor Samples From Surgery to Predict Response to Treatment for Brain Metastasis

A Feasibility Study to Determine if a Novel Patient-derived Explant Platform Can Produce Drug Sensitivity Scores Within a Clinically Relevant Time Frame in Patients With CNS Tumors Scientific Title

Purpose
To study a new way to predict response to treatment using tumor samples from brain surgery.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive brain 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">Collection of tumor samples during brain surgery</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers will use tumor samples from brain surgery to determine which types of treatments are most likely to be effective.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05978557' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
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40

NEAREST SITE: 2380 miles
Morton Plant Hospital - Baycare Health System
Clearwater,FL

VISITS: 5 doses per week for 3-6 weeks

PHASE: II

NCT ID: NCT05528133

Personalizing Radiation Therapy for Stage I-III Triple Negative Breast Cancer

Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer Scientific Title

Purpose
To study the effects (good and bad) and anti-cancer activity of using the radiosensitivity index to personalize treatment with radiation therapy.
Who is this for?
People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer who have received a lumpectomy and lymph node biopsy.    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: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation based on radiosensitivity index, 5 doses per week for 3-6 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation, 5 doses per week for 4-6 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">The radiosensitivity index is a test that evaluates 10 genes to determine the sensitivity of a tumor to radiation. This test may help personalize the radiation dose for a person.</li> <li class="seamTextUnorderedListItem">A lumpectomy is sometimes called a partial mastectomy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05528133' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://moffitt.org/newsroom/press-release-archive/moffitt-researchers-develop-model-to-personalize-radiation-treatment-for-breast-cancer-patients/' target='_blank'>Moffitt Cancer Center: Radiosensitivity Index</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li></ul>
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41

NEAREST SITE: 2383 miles
Mayo Clinic in Florida
Jacksonville,FL

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05447910

Analysis of Letrozole in Patients With Operable Hormone Receptor Positive, HER2 Negative Breast Cancer

Comprehensive Single-Cell Transcriptional Analysis of Aromatase Inhibitor-Resistant Breast Cancer Scientific Title

Purpose
To study the effects (good and bad) of neoadjuvant (before surgery) letrozole (Femara®) on breast tumors.
Who is this for?
Postmenopausal women with stage I, stage II, or some stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have not yet received 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 receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily for 2-8 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone receptor positive breast cancer.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) decreases the amount of estrogen produced by the body. This can slow or stop the growth of some types of breast cancer cells that need estrogen to grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) will be given before surgery (neoadjuvant).</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05447910' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/femara' target='_blank'>Breastcancer.org: Letrozole (Femara®)</a> </li></ul>
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42

NEAREST SITE: 2406 miles
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill,NC

VISITS: 3 visits

PHASE: NA

NCT ID: NCT01000883

Identifying Tumor Markers That Predict Treatment Response for Advanced Breast Cancer

Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior Scientific Title

Purpose
To collect biological specimens and clinical information to identify tumor markers that predict treatment response.
Who is this for?
People with advanced (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"> You will receive the following at diagnosis, during chemotherapy, and prior to surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Core biopsy</li> <li class="seamTextUnorderedListItem">Blood sampling</li> <li class="seamTextUnorderedListItem">Assessment of tumor markers</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are trying to find ways to determine which tumors will respond to which treatments.</li> <li class="seamTextUnorderedListItem">Studying tumor tissue and blood samples from patients before and after cancer treatments may help researchers identify tumor markers that can guide treatment choices.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01000883' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/mbc-pharmacogenomics/' target='_blank'>Metastatic Trial Talk: Why Does The Same Drug Work Differently In Different People?</a> </li></ul>
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43

NEAREST SITE: 2437 miles
Penn State Health College of Medicine
Hershey,PA

VISITS: 5 visits within up to 5 years

PHASE: NA

NCT ID: NCT05957042

Ultrasound to Predict Response to Chemotherapy and Immunotherapy for Stage I-IV Triple Negative Breast Cancer

Pilot Study to Evaluate if Contrast Enhanced Ultrasound (CEUS) Can Predict Treatment Response in Triple Negative Breast Cancer (TNBC) Patients Receiving Combined Chemotherapy and Immune Checkpoint Inhibitors (ICI). Scientific Title

Purpose
To study if ultrasound with sulfur hexafluoride (Lumason®) can predict response to chemotherapy and immunotherapy.
Who is this for?
People with stage I, stage II, stage III, or stage IV (metastatic) triple negative (ER-, PR-, HER2-) breast cancer who are planning to receive chemotherapy and immunotherapy.    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">Sulfur hexafluoride (Lumason®), by IV, 4 times within up to 5 years</li> <li class="seamTextUnorderedListItem">Ultrasound, 5 times within up to 5 years</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sulfur hexafluoride (Lumason®) is a tracer that can look for and attach to cancer cells which improves visibility in an ultrasound.</li> <li class="seamTextUnorderedListItem">Sulfur hexafluoride (Lumason®) is approved for use in other conditions. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Ultrasounds use sound waves to produce images of structures within your body.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05957042' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.everydayhealth.com/drugs/sulfur-hexafluoride' target='_blank'>Everyday Health: Sulfur Hexafluoride for Ultrasound</a> </li></ul>
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44

NEAREST SITE: 2453 miles
Johns Hopkins University
Baltimore,MD

VISITS: 2 visits in the first month; visits every 3-4 months while on treatment

PHASE: II

NCT ID: NCT03439735

Predicting Response to Treatment with an Aromatase Inhibitor and Palbociclib for Advanced HR+ Breast Cancer

Prospective Evaluation of Determinants of Resistance to First-line Therapy With an Aromatase Inhibitor and the Cyclin-dependent Kinases 4 and 6 Inhibitor Palbociclib in Hormone Receptor Positive Metastatic Breast Cancer Scientific Title

Purpose
To see if certain blood and tumor tests can help researchers predict which tumors will respond to an aromatase inhibitor and palbociclib (Ibrance®).
Who is this for?
People with newly diagnosed advanced (some stage III) and metastatic (stage IV), hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who will be treated with an aromatase inhibitor and palbociclib (Ibrance®).    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draws: at the start of treatment, at 1 month, and then every 3-4 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The researchers will analyze tumor tissue and blood samples during treatment. </li> <li class="seamTextUnorderedListItem">They will be looking specifically at a mutation, called ESR1, that can develop in cancer cells. </li> <li class="seamTextUnorderedListItem">Previous studies have suggested that cancer cells with this mutation may be less likely to respond to an aromatase inhibitor. </li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. It is approved for use in people with metastatic hormone positive, HER2 negative breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03439735' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ibrance.com/?src_code=IBRW10028851' target='_blank'>Pfizer Oncology Information Page: Ibrance</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medpagetoday.com/clinical-challenges/sabcs-breast-cancer/76896' target='_blank'>Medpage Today: What's Next for CDK4/6 Therapy?</a> </li></ul>
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45

NEAREST SITE: 2494 miles
Lehigh Valley Health Network
Allentown,PA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT01775072

Analyzing Tumor Mutations Before and After Treatment with Targeted Therapies

A Basket Study: Tumor Genomic Profiling in Patients Evaluated for Targeted Cancer Therapy Scientific Title

Purpose
To compare genetic mutations seen in a tumor sample before and after treatment with a targeted therapy. The study will investigate how tumor mutations can be used to predict a cancer's response to treatment and how they change in response to targeted therapies.
Who is this for?
People who are receiving ongoing care at Memorial Sloan Kettering Cancer Center.    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 be asked to provide: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A tube of blood</li> <li class="seamTextUnorderedListItem">Cheek swab (also known as a buccal), or a saliva sample that contains normal genes for comparison</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Leftover tumor tissue from a previous surgery or biopsy will be used for genomic testing.</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Most genetic mutations found in cancer cells are not passed down from parents (inherited), but occur when the cells make mistakes when they divide.</li> <li class="seamTextUnorderedListItem">Most cancers have many mutations.</li> <li class="seamTextUnorderedListItem">Some of these mutations help drive the tumor's growth, while others are just bystanders.</li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket trials enroll people based on the kind of mutations found in their tumors.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01775072' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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46

NEAREST SITE: 2517 miles
Abramson Cancer Center of the University of Pennsylvania
Philadelphia,PA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT02530008

Identifying Genetic and Molecular Markers of Recurrence in Breast Cancer Cells

Breast Cancer 2-PREVENT Translational Center of Excellence (TCE) - Metastatic Markers of Recurrent Tumor Phenotype for Breast Cancer Scientific Title

Purpose
To gather information on the molecular and genetic changes seen in patients whose cancer has recurred or metastasized.
Who is this for?
Women receiving care at the University of Pennsylvania Rowan Breast Center who have not yet started treatment for recurrent or metastatic (stage IV) disease.    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: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy</li> <li class="seamTextUnorderedListItem">Blood collections</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cancer cells accumulate many different types of alterations and mutations. </li> <li class="seamTextUnorderedListItem">Researchers want to know if some of these changes provide information about whether the tumor is at high risk for recurring or metastasizing (spreading to other parts of the body).</li> </ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02530008' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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47

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ

VISITS: 1 visit every month

PHASE: I-II

NCT ID: NCT06110793

Targeted Therapy and Hormone Therapy for Advanced ER+ or ER Low, HER2- Breast Cancer

A Phase Ib/II Trial of Lenvatinib Plus Pembrolizumab Plus Fulvestrant in ER-positive/ HER2- Negative Metastatic Breast Cancer Scientific Title

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of lenvatinib (Lenvima®) tyrosine kinase inhibitor, pembrolizumab (Keytruda®) PD-1 inhibitor, and fulvestrant (Faslodex®) hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) or ER low, HER2 negative (HER2-) breast cancer who have received hormone therapy with a CDK4/6 inhibitor for advanced disease. You must not have received more than 2 lines of chemotherapy for advanced disease or a PD-1/PD-L1 inhibitor.    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">Lenvatinib (Lenvima®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 1.5 months</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by IV, monthly</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Premenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06110793' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a615015.html' target='_blank'>MedlinePlus: Lenvatinib (Lenvima®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
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48

NEAREST SITE: 2549 miles
Rutgers Cancer Institute of New Jersey
New Brunswick,NJ

VISITS: 10 visits within 5 years

PHASE: II

NCT ID: NCT05949021

Chemotherapy After Surgery for Women with Stage I-II Triple Negative Breast Cancer

OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-stage Triple Negative Breast Cancer Scientific Title

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of liposomal doxorubicin (Adriamycin®) and carboplatin (Paraplatin®) chemotherapy after surgery (adjuvant).
Who is this for?
Women with stage I or stage II triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer who have received 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">Liposomal doxorubicin (Adriamycin®), monthly for 4 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), monthly for 4 months</li> <li class="seamTextUnorderedListItem">ctDNA tests, 7 visits within 5 years</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Liposomal doxorubicin (Adriamycin®) and carboplatin (Paraplatin®) are chemotherapy drugs commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Liposomal doxorubicin (Adriamycin®) is doxorubicin (Adriamycin®) in tiny spheres that keep the drug in the bloodstream longer so that more drug reaches the cancer cells.</li> <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">This trial is also studying the use of ctDNA to detect treatment response and disease progression.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/FISH negative.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05949021' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/treatment/drugs/liposomal-doxorubicin' target='_blank'>Cancer Research UK: Liposomal Doxorubicin (Adriamycin®)</a> </li></ul>
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49

NEAREST SITE: 2567 miles
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York,NY

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05559853

MRI Scan to Study Changes in Brain Tumors After Treatment

Development of a Clinical CEST MR Fingerprinting Method for Treatment Response Assessment in Brain Metastases Scientific Title

Purpose
To develop a new MRI scan technique that will study the difference between tumor growth from cancer progression and tumor growth from treatment side effects.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive stereotactic radiosurgery. You must have at least 1 brain tumor that has not received radiation.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> ou will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Magnetic resonance fingerprinting</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Magnetic resonance fingerprinting is a type of MRI scan.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05559853' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
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50

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

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT03165487

Breast Tissue Study in Women 40 and Older Having a Lumpectomy

Differential Comparison of the Breast Tumor Microenvironment Between Luminal A and Triple Negative Breast Cancer With and Without Radiation Treatment Scientific Title

Purpose
To study the healthy tissue surrounding your tumor to determine if this tissue affects how your cancer cells behave.
Who is this for?
Women with DCIS or stage I or stage II, HER2 negative (HER2-) breast cancer. You must also be 40 or older, have had a mammogram within the past six months, and be receiving treatment at the Breast Surgery and Radiation Oncology Clinics of Columbia University.    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> <i class="seamTextEmphasis">During surgery</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 tissue and blood samples will be collected</li> <li class="seamTextUnorderedListItem">Samples will be collected before and after you receive intraoperative radiotherapy</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03165487' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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51

NEAREST SITE: 2587 miles
Miami Cancer Institute
Miami,FL

VISITS: 3 visits

PHASE: I

NCT ID: NCT04689048

18F-Fluciclovine and PET/CT Scans for Brain Metastasis

Characterization of Large Brain Metastases With 18F-Fluciclovine PET/CT Treated With Staged Stereotactic Radiosurgery Scientific Title

Purpose
To study the ability of 18F-fluciclovine and PET/CT scans to detect responses to radiation therapy and changes in brain metastasis.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive treatment with stereotactic radiosurgery. You must have at least 1 brain tumor that has not received 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 receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">18F-fluciclovine (Axumin®), by IV, 3 times</li> <li class="seamTextUnorderedListItem">PET/CT brain scans, 3 scans</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">18F-fluciclovine is an experimental tracer that may be able to detect your response to staged stereotactic radiosurgery.</li> <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 computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">The PET/CT scans will be administered before, during, and after treatment with stereotactic radiosurgery.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04689048' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
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52

NEAREST SITE: 2591 miles
University of Miami
Miami,FL

VISITS: At least 1 visit every 2 months

PHASE: II

NCT ID: NCT05826964

ctDNA Blood Tests to Determine an Early Switch in Treatment for Metastatic ER+, HER2- or HER2 Low Breast Cancer

Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer: A Phase 2 Randomized, Open-Label Study Scientific Title

Purpose
To determine whether switching treatment earlier will increase the amount of time that metastatic breast cancer is controlled.
Who is this for?
People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low breast cancer who have not yet received treatment for advanced 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 be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: No Treatment Change</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ctDNA test, monthly for 2 months, then every 2 months</li> <li class="seamTextUnorderedListItem">Standard of care: CDK4/6 inhibitor with aromatase inhibitor or CDK4/6 inhibitor with selective estrogen receptor degrader (SERD)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Switch to new treatment (if progression occurs, optional)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Early Treatment Change</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ctDNA test, monthly for 2 months, then every 2 months</li> <li class="seamTextUnorderedListItem">Standard of care: CDK4/6 inhibitor with aromatase inhibitor or CDK4/6 inhibitor with selective estrogen receptor degrader (SERD)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Early switch to a new treatment, for 1 year 2 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests will be used to indicate tumor biomarkers and the presence of circulating tumor (ctDNA).</li> <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">In this trial, HER2 low is define as IHC 1+ or 2+/FISH-.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®) are types of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">If you are premenopausal, you must also take a drug that will put women in temporary menopause.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05826964' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/ctdna-mbc/' target='_blank'>Metastatic Trial Talk: The Latest Research on ctDNA and MBC</a> </li></ul>
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