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1

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

Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies

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. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor samples</li></ul>

What's being studied?

<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>

How can I learn more?

<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>
1

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

Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies
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Nearest Location:
4 miles
Curebase
San Francisco, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04510129

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Phase NA

2

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

Molecular Analysis for Combination Therapy Choice (ComboMATCH)

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
2

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

Molecular Analysis for Combination Therapy Choice (ComboMATCH)
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Nearest Location:
5 miles
UCSF Medical Center-Mission Bay
San Francisco, CA

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Visits:
Please contact research site

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ClinicalTrials.gov: NCT05564377

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Phase II

3

Registry to Study Advanced Breast Cancer and Treatment Response

Prospective Biospecimen Repository in Metastatic Breast Cancer

Purpose: To create a registry that will be used to study how breast cancer spreads and why people respond differently to specific breast cancer treatments.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsies</li> <li class="seamTextUnorderedListItem">Blood samples</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The blood and tissue/biopsy samples will be used to conduct DNA and circulating tumor cell (CTC) testing.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03737695' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cdc.gov/cancer/npcr/value/registries.htm' target='_blank'>CDC: How Cancer Registries Work</a> </li></ul>
3

Registry to Study Advanced Breast Cancer and Treatment Response

Prospective Biospecimen Repository in Metastatic Breast Cancer
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Nearest Location:
5 miles
UCSF Medical Center-Mission Bay
San Francisco, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT03737695

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Phase NA

4

Malignant Fluid Test to Predict Response to Treatment for Breast Cancer

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

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. View full eligibility criteria

What's involved?

<p class="seamTextPara"> Additional malignant fluid will be collected as part of a standard of care procedure.</p>

What's being studied?

<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>

How can I learn more?

<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>
4

Malignant Fluid Test to Predict Response to Treatment for Breast Cancer

Mass Response of Malignant Fluid Cells as a Biomarker for Rapid Therapy Guidance
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Nearest Location:
8 miles
xCures
Oakland, CA

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Visits:
Coincides with routine care

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ClinicalTrials.gov: NCT05461430

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Phase NA

5

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

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. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will complete the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Symptom diary</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<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>

How can I learn more?

<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>
5

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
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Nearest Location:
51 miles
Research Site
Santa Rosa, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05592483

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Phase NA

6

NCI Cancer Moonshot Biobank for Stage III-IV Breast Cancer

Cancer Moonshot Biobank Research Protocol

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
6

NCI Cancer Moonshot Biobank for Stage III-IV Breast Cancer

Cancer Moonshot Biobank Research Protocol
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Nearest Location:
170 miles
Carson Tahoe Regional Medical Center
Carson City, NV

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Visits:
Coincides with routine care

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ClinicalTrials.gov: NCT04314401

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Phase NA

7

Low Calorie Diet to Reduce Chemotherapy Side Effects for People with Stage I-IV Breast Cancer

A Randomized, Phase II Clinical Trial of a Controlled Diet Prior to Selected Chemotherapy Treatment in Breast and Prostate Cancer to Evaluate the Impact on Toxicity and Efficacy

Purpose: To study how well a low calorie diet works in reducing side effects and increasing response to chemotherapy.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are receiving AC (doxorubicin plus cyclophosphamide) chemotherapy. You must not have received any other chemotherapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental Diet</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eat a low-calorie diet during before, during, and after chemotherapy (all food is provided)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Normal Diet</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eat a normal diet</li> <li class="seamTextUnorderedListItem">Complete a food diary</li> <li class="seamTextUnorderedListItem">Receive advice from a nutritionist</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.</li> <li class="seamTextUnorderedListItem">Eating a special diet with low calories may reduce the side effects of chemotherapy and improve the response to treatment.</li> <li class="seamTextUnorderedListItem">If you are in group 1, all food will be provided.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01802346' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/chemotherapy/side_effects' target='_blank'>Breastcancer.org: Chemotherapy Side Effects</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-treating-chemotherapy' target='_blank'>Cancer.gov: Chemotherapy</a> </li></ul>
7

Low Calorie Diet to Reduce Chemotherapy Side Effects for People with Stage I-IV Breast Cancer

A Randomized, Phase II Clinical Trial of a Controlled Diet Prior to Selected Chemotherapy Treatment in Breast and Prostate Cancer to Evaluate the Impact on Toxicity and Efficacy
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Nearest Location:
350 miles
USC Norris Comprehensive Cancer Center
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT01802346

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Phase NA

8

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

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®). View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
8

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
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Nearest Location:
355 miles
City of Hope Medical Center
Duarte, CA

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Visits:
1 visit every 1-2 months

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ClinicalTrials.gov: NCT05376878

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Phase III-IV

9

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

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
9

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
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Nearest Location:
377 miles
Knowledge Research Center
Orange, CA

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

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ClinicalTrials.gov: NCT04638751

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Phase NA

10

Biopsy to Select Treatment for Metastatic HER2-Negative Breast Cancer

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

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. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy to collect tumor tissue</li></ul>

What's being studied?

<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>

How can I learn more?

<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>
10

Biopsy to Select Treatment for Metastatic HER2-Negative Breast Cancer

FORESEE: Functional Precision Oncology for Metastatic Breast Cancer: a Feasibility Trial
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Nearest Location:
602 miles
Huntsman Cancer Institute at University of Utah
Salt Lake City, UT

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04450706

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Phase NA

11

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

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 View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
11

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
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Nearest Location:
942 miles
University of Colorado Denver
Aurora, CO

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT01503190

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Phase NA

12

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

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
12

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
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Nearest Location:
1615 miles
Mayo Clinic in Rochester
Rochester, MN

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Visits:
Coincides with radiation therapy

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ClinicalTrials.gov: NCT04308720

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Phase NA

13

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)

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. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<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>

How can I learn more?

<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>
13

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)
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Nearest Location:
1615 miles
Mayo Clinic in Rochester
Rochester, MN

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06055881

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Phase NA

14

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

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
14

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
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Nearest Location:
1644 miles
Baylor College of Medicine
Houston, TX

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Visits:
1 visit every 3 months

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ClinicalTrials.gov: NCT05721248

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Phase II

15

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

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
15

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
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Nearest Location:
1678 miles
UW Carbone Cancer Center
Madison, WI

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Visits:
2 visits within 1 month

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ClinicalTrials.gov: NCT06067503

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Phase II

16

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

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
16

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
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Nearest Location:
1739 miles
Washington University School of Medicine
Saint Louis, MO

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

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ClinicalTrials.gov: NCT04968964

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Phase NA

17

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

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
17

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
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Nearest Location:
1761 miles
University of Wisconsin School of Medicine and Public Health
Madison, WI

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04573231

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Phase II

18

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

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

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. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Guardant360 blood test</li></ul>

What's being studied?

<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>

How can I learn more?

<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>
18

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

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
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Nearest Location:
1849 miles
Orchard Healthcare Research Inc.
Skokie, IL

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05935384

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Phase NA

19

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

PhOCus: Implementation of Pharmacogenomic Testing in Oncology Care

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
19

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

PhOCus: Implementation of Pharmacogenomic Testing in Oncology Care
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Nearest Location:
1857 miles
University of Chicago Medical Center
Chicago, IL

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04541381

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Phase NA

20

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

Organoid Model Predictive of Response to Immunotherapies

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. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy sample</li></ul>

What's being studied?

<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>

How can I learn more?

<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>
20

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

Organoid Model Predictive of Response to Immunotherapies
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Nearest Location:
1946 miles
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, IN

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Visits:
1 visit

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ClinicalTrials.gov: NCT06084676

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Phase NA

21

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)

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
21

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)
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Nearest Location:
1958 miles
Vanderbilt University/Ingram Cancer Center
Nashville, TN

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05693766

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Phase II

22

ctDNA Tests to Support Treatment Decisions for People with Metastatic Triple Negative, PD-L1 Negative Breast Cancer

A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer

Purpose: To study how well circulating tumor DNA (ctDNA) tests work to support decisions to change treatment.

Who is this for?: People with metastatic (stage IV) triple negative (ER-, PR-, HER2-), PD-L1 negative breast cancer who have not received chemotherapy for metastatic disease. View full eligibility criteria

What's involved?

<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">Standard of care chemotherapy</li> <li class="seamTextUnorderedListItem">Blood samples for ctDNA tests</li> <li class="seamTextUnorderedListItem">CT scan or MRI scan, 2 times</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> <li class="seamTextUnorderedListItem">Blood samples for ctDNA tests</li> <li class="seamTextUnorderedListItem">CT scan or MRI scan, 2 times</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Switch to sacituzumab govitecan (Trodelvy®), by IV (depending on blood test results)</li></ul>

What's being studied?

<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">Studying ctDNA may help your doctor decide to change your treatment earlier (if needed) and may improve your health outcomes.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a type of targeted therapy called 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">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</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>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05770531' 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.breastcancer.org/treatment/targeted-therapy/trodelvy' target='_blank'>Breastcancer.org: Sacituzumab Govitecan (Trodelvy®)</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>
22

ctDNA Tests to Support Treatment Decisions for People with Metastatic Triple Negative, PD-L1 Negative Breast Cancer

A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer
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Nearest Location:
1958 miles
Vanderbilt University/Ingram Cancer Center
Nashville, TN

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Visits:
Coincides with routine care

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ClinicalTrials.gov: NCT05770531

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Phase II

23

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

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
23

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
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Nearest Location:
1960 miles
Vanderbilt University/Ingram Cancer Center
Nashville, TN

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Visits:
2 visits within up to 4 years

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ClinicalTrials.gov: NCT05996432

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Phase NA

24

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)

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
24

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)
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Nearest Location:
2013 miles
The University of Alabama at Birmingham
Birmingham, AL

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Visits:
3 visits within 6 months

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ClinicalTrials.gov: NCT04273555

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Phase I-II

25

PIONEER Initiative: Precision Medicine Registry to Guide Treatment Decisions for People with DCIS or Stage I-IV Breast Cancer

The PIONEER Initiative: Precision Insights On N-of-1 Effectiveness Research. Tissue Ownership by the Individual With the Return of Actionable Information to the Individual Patient and Physician (Precision Oncology)

Purpose: To use information from biopsy samples to guide treatment decisions and create a registry to discover new cancer diagnostics, treatments, and preventive strategies.

Who is this for?: People with DCIS, stage I, stage II, stage III, or stage IV (metastatic) breast cancer, or people with a high risk of developing breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor sample from biopsy or surgery</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The mission of this trial is to provide precision medicine to people who receive local cancer care at institutions that do not have significant research capabilities or are not NCI-designated cancer centers.</li> <li class="seamTextUnorderedListItem">The underlying basic assumption of the PIONEER Initiative is that the ability to receive the best in cancer care should not be restricted as to location, age, or medical condition. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03896958' 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: Precision Medicine for Breast Cancer</a> </li></ul>
25

PIONEER Initiative: Precision Medicine Registry to Guide Treatment Decisions for People with DCIS or Stage I-IV Breast Cancer

The PIONEER Initiative: Precision Insights On N-of-1 Effectiveness Research. Tissue Ownership by the Individual With the Return of Actionable Information to the Individual Patient and Physician (Precision Oncology)
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Nearest Location:
2156 miles
Specicare
Gainesville, GA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT03896958

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Phase NA

26

Studying 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

Purpose: To study how breast cancer develops resistance to CDK 4/6 inhibitors and how to predict response to CDK 4/6 inhibitors.

Who is this for?: People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer or peoole with stage I, stage II, or stage IV hormone receptor positive (ER+ and/or PR+), HER2 negative (HER-) node positive breast cancer. You must currently be receiving treatment with or completed treatment with a CDK 4/6 inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Provide blood, tissue, and biopsy samples</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <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>

How can I learn more?

<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>
26

Studying 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
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Nearest Location:
2299 miles
Roswell Park Cancer Institute
Buffalo, NY

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04526587

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Phase NA

27

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

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. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Collection of tumor samples during brain surgery</li></ul>

What's being studied?

<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>

How can I learn more?

<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>
27

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
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Nearest Location:
2378 miles
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, NC

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Visits:
Coincides with routine care

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ClinicalTrials.gov: NCT05978557

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Phase NA

28

Identifying Tumor Markers That Predict Treatment Response for Advanced Breast Cancer

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

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
28

Identifying Tumor Markers That Predict Treatment Response for Advanced Breast Cancer

Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior
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Nearest Location:
2407 miles
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, NC

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Visits:
3 visits

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ClinicalTrials.gov: NCT01000883

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Phase NA

29

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).

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
29

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).
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Nearest Location:
2437 miles
Penn State Health College of Medicine
Hershey, PA

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Visits:
5 visits within up to 5 years

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ClinicalTrials.gov: NCT05957042

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Phase NA

30

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

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®). View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
30

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
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Nearest Location:
2453 miles
Johns Hopkins University
Baltimore, MD

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

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ClinicalTrials.gov: NCT03439735

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Phase II

31

Analyzing Tumor Mutations Before and After Treatment with Targeted Therapies

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

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
31

Analyzing Tumor Mutations Before and After Treatment with Targeted Therapies

A Basket Study: Tumor Genomic Profiling in Patients Evaluated for Targeted Cancer Therapy
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Nearest Location:
2494 miles
Lehigh Valley Health Network
Allentown, PA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT01775072

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Phase NA

32

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

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
32

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
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Nearest Location:
2517 miles
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, PA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT02530008

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Phase NA

33

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

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
33

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
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Nearest Location:
2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, NJ

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Visits:
1 visit every month

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ClinicalTrials.gov: NCT06110793

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Phase I-II

34

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

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
34

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

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05559853

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Phase NA

35

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

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

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
35

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

Characterization of Large Brain Metastases With 18F-Fluciclovine PET/CT Treated With Staged Stereotactic Radiosurgery
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Nearest Location:
2588 miles
Miami Cancer Institute
Miami, FL

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Visits:
3 visits

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ClinicalTrials.gov: NCT04689048

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Phase I

36

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

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. View full eligibility criteria

What's involved?

<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>

What's being studied?

<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>

How can I learn more?

<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>
36

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
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Nearest Location:
2592 miles
University of Miami
Miami, FL

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Visits:
At least 1 visit every 2 months

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ClinicalTrials.gov: NCT05826964

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Phase II

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