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1

Circulating Tumor Cells Test to Make Treatment Decisions for Metastatic Breast Cancer

ACT-MBC: A Prospective Observational Impact Study of Circulating Tumor Cells <span class="highlight">(CTCs)</span> in Metastatic Breast Cancer

Purpose: To study whether the CELLSEARCH® Circulating Tumor Cell Test helps doctors make treatment decisions and determine response to treatment.

Who is this for?: People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or triple negative (ER-, PR-, HER2-) breast cancer. If you have ER+, HER2- breast cancer, you must have received at least 1 line of therapy for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood sample for CELLSEARCH® Circulating Tumor Cell Test</li> </ul> <p class="seamTextPara"> followed within 1.5 years by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imaging scans, at least 1 time</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Circulating tumor cells <span class="highlight">(CTCs)</span> are cancer cells from a tumor that circulate in the bloodstream.</li> <li class="seamTextUnorderedListItem">The CELLSEARCH® Circulating Tumor Cell Test can detect <span class="highlight">CTCs</span> in your blood to help your doctor make treatment decisions and determine your response to 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/NCT05662345' target='_blank'>ClinicalTrials.gov</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://www.cellsearchctc.com/about-cellsearch/what-is-cellsearch-ctc-test' target='_blank'>Menarini Silicon Biosystems: CELLSEARCH® Circulating Tumor Cell Test</a> </li></ul>
1

Circulating Tumor Cells Test to Make Treatment Decisions for Metastatic Breast Cancer

ACT-MBC: A Prospective Observational Impact Study of Circulating Tumor Cells <span class="highlight">(CTCs)</span> in Metastatic Breast Cancer
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Nearest Location:
1539 miles
Mayo Clinic Health System Mankato
Mankato, MN

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Visits:
At least 2 visits

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ClinicalTrials.gov: NCT05662345

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Phase NA

2

Radiation to Delay Treatment Changes and <span class="highlight">CTCs</span> 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 <span class="highlight">(CTCs)</span> 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 <span class="highlight">(CTCs)</span> are cancer cells from a tumor that circulate in the bloodstream.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">CTCs</span> 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>
2

Radiation to Delay Treatment Changes and <span class="highlight">CTCs</span> 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

3

BL-M07D1 ADC for Advanced HER2 Positive, HER2 Low, and HER2 Expressing Breast Cancer

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors

Purpose: To study the safety, best dose, and effects (good and bad) of BL-M07D1, an experimental antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+), HER2 low, or HER2 amplified breast cancer who have received at least 2 lines of therapy. You are also eligible if circulating tumor cells <span class="highlight">(CTCs)</span> are HER2 amplified. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BL-M07D1, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BL-M07D1 is an experimental 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">BL-M07D1's antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called trastuzumab.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</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/NCT06293898' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://systimmune.com/bl-m07d1' target='_blank'>SystImmune: BL-M07D1 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>
3

BL-M07D1 ADC for Advanced HER2 Positive, HER2 Low, and HER2 Expressing Breast Cancer

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors
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Nearest Location:
1643 miles
SystImmune Recruiting Site
Houston, TX

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT06293898

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Phase I

4

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, at baseline and at 1 month</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times, at baseline and at 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 <span class="highlight">(CTC)</span> testing.</li> <li class="seamTextUnorderedListItem">Circulating tumor cells <span class="highlight">(CTCs)</span> 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>
4

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

5

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 <span class="highlight">(CTC)</span> 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 <span class="highlight">(CTCs)</span> 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>
5

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

6

Keytruda with Chemotherapy for Treating HER2- Metastatic Breast Cancer

I-CURE-1: A Phase II, Single Arm Study of Pembroluzimab Combined With Carboplatin in Patients With Circulating Tumor Cells <span class="highlight">(CTCs)</span> Positive Her-2 Negative Metastatic Breast Cancer (MBC)

Purpose: To determine the safety and effects (good and bad) of treating HER2-negative metastatic breast cancer with an immunotherapy drug along with a chemotherapy drug.

Who is this for?: People with metastatic (stage IV) breast cancer that is HER2 negative. If you are estrogen receptor positive, you must have progressed on available endocrine therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for up to 2 years</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for up to 2 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy drug used in this study is pembrolizumab (Keytruda®). It is a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">The chemotherapy drug is carboplatin (Paraplatin®). It is used to treat metastatic 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/NCT03213041' target='_blank'>ClinicalTrials.gov</a> </li></ul>
6

Keytruda with Chemotherapy for Treating HER2- Metastatic Breast Cancer

I-CURE-1: A Phase II, Single Arm Study of Pembroluzimab Combined With Carboplatin in Patients With Circulating Tumor Cells <span class="highlight">(CTCs)</span> Positive Her-2 Negative Metastatic Breast Cancer (MBC)
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Nearest Location:
1856 miles
Northwestern University
Chicago, IL

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Visits:
1 visit every 3 weeks, ongoing

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ClinicalTrials.gov: NCT03213041

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Phase II

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