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1

Radiation-Activated NBTXR3 Nanoparticle and Immunotherapy for Metastatic Breast Cancer

A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of NBTXR3, an experimental nanoparticle, and stereotaxic ablative radiotherapy, with nivolumab (Opdivo®) or pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the soft tissues, lungs, or <span class="highlight">liver.</span> View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NBTXR3, by intratumoral injection, 1 time</li> <li class="seamTextUnorderedListItem">Stereotaxic ablative radiotherapy</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) or pembrolizumab (Keytruda®)</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">NBTXR3 is an experimental nanoparticle designed to kill cancer cells that is activated by stereotaxic ablative radiotherapy.</li> <li class="seamTextUnorderedListItem">NBTXR3 will be injected directly into your tumor.</li> <li class="seamTextUnorderedListItem">Stereotaxic ablative radiotherapy, also called stereotactic radiation or stereotactic radiosurgery, delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</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/NCT03589339' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nanobiotix.com/clinical-trials/' target='_blank'>Nanobiotix Drug Information Page: NBTXR3</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/sbrt/pyc-20446794' target='_blank'>Mayo Clinic: Stereotaxic Ablative Radiotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Nivolumab (Opdivo®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
1

Radiation-Activated NBTXR3 Nanoparticle and Immunotherapy for Metastatic Breast Cancer

A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy
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Nearest Location:
3 miles
University of California San Francisco
San Francisco, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT03589339

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Phase I

2

XTX301 Immunotherapy for Advanced Triple Negative Breast Cancer

A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX301 in Patients with Advanced Solid Tumors

Purpose: To study the safety, best dose, and effects (good and bad) of XTX301, an experimental immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received no more than 4 lines of therapy for advanced disease. You must not have <span class="highlight">liver</span> metastases. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XTX301</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XTX301 is an experimental immunotherapy called interleukin-12 (IL-12).</li> <li class="seamTextUnorderedListItem">IL-12 activates immune cells to kill cancer cells.</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/NCT05684965' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://xiliotx.com/pipeline/xtx301' target='_blank'>Xilio: XTX301 Drug Information Page</a> </li></ul>
2

XTX301 Immunotherapy for Advanced Triple Negative Breast Cancer

A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX301 in Patients with Advanced Solid Tumors
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Nearest Location:
74 miles
University of California, Davis Comprehensive Cancer Center
Sacramento, CA

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Visits:
About 1 visit every 3 weeks

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ClinicalTrials.gov: NCT05684965

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Phase I-II

3

PET/CT Scan to Predict Response to Abemaciclib for Advanced ER+, HER2- Breast Cancer

A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

Purpose: To study how well functional imaging PET/CT scans with FFNP can predict your cancer's response to abemaciclib (Verzenio®) CDK4/6 inhibitor with standard of care 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-) or HER2 low breast cancer who are planning to receive abemaciclib (Verzenio®). You must have received no more than 1 line of chemotherapy for advanced disease. You must not have <span class="highlight">liver</span> only metastases. 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 FFNP, by IV, 3 times in 1 month, then every 3 months</li> <li class="seamTextUnorderedListItem">Estradiol, by mouth, 1 day</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">FFNP PET/CT imaging is a form of x-ray that uses FFNP as an imaging agent that may provide more precise information about the location of tumors that <q>light up</q> with FFNP than a PET scan alone can provide.</li> <li class="seamTextUnorderedListItem">Estradiol is type of hormone therapy for advanced ER+ breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or FISH -.</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/NCT06179303' target='_blank'>ClinicalTrials.gov</a> </li></ul>
3

PET/CT Scan to Predict Response to Abemaciclib for Advanced ER+, HER2- Breast Cancer

A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
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Nearest Location:
682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle, WA

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Visits:
3 visits in 1 month, then 1 visit every 3 months

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ClinicalTrials.gov: NCT06179303

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Phase II

4

Wearable Device for Metastatic Breast Cancer that has Spread to the Leptomeninges

Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases From Breast Carcinoma Involving the Spine

Purpose: This trial will study the safety and effects (good and bad) of the Novo TTF-200T device.

Who is this for?: People with stage IV (metastatic) breast cancer that has spread to the leptomeninges (the lining of the brain and spinal cord). You must not be receiving high-dose methotrexate, thiotepa, or cytarabine. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The portable Novo TTF-200T device to wear</li> <li class="seamTextUnorderedListItem">MRI scan</li> <li class="seamTextUnorderedListItem">Possible lumbar puncture (also called a spinal tap), 2 times</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Novo TTF-200T device is a wearable device that produces electric fields to target areas on the body to stop the growth of tumor cells. </li> <li class="seamTextUnorderedListItem">The device has breakthrough designation from the FDA for advanced <span class="highlight">liver</span> cancer and is being tested in other advanced cancers including MBC.</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/NCT05746325' 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.cancernetwork.com/view/novottf-200t-delivery-system-given-a-breakthrough-designation-by-the-fda-for-advanced-liver-cancer' target='_blank'>Cancer Network: The Novo TTF-200T Device</a> </li></ul>
4

Wearable Device for Metastatic Breast Cancer that has Spread to the Leptomeninges

Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases From Breast Carcinoma Involving the Spine
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Nearest Location:
2383 miles
Mayo Clinic in Florida
Jacksonville, FL

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05746325

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Phase NA

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