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1

Radiation-Activated NBTXR3 Nanoparticle and <span class="highlight">Immunotherapy</span> 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 liver. 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 <span class="highlight">radiation</span> or stereotactic radiosurgery, delivers high-dose, precisely-targeted <span class="highlight">radiation</span> in fewer doses than traditional <span class="highlight">radiation</span> 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 <span class="highlight">Immunotherapy</span> 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

RYZ101 Radioactive Drug with <span class="highlight">Immunotherapy</span> for Advanced ER+, HER2- Breast Cancer Expressing SSTRs

Phase 1b/2 Open-label Trial of 225Ac-DOTATATE (RYZ101) Alone and in Combination with Pembrolizumab in Subjects with Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) and Progressed After Antibody-drug Conjugates And/or Chemotherapy (TRACY-1)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of RYZ101, an experimental radioactive drug, with pembrolizumab (Keytruda®) <span class="highlight">immunotherapy.</span>

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor (ER+) or ER low, HER2 negative (HER2-) or HER2 low breast cancer that expresses somatostatin receptors (SSTRs) 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">225Ac-DOTATATE (RYZ101)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are developing a new class of drugs called radiopharmaceuticals, which deliver <span class="highlight">radiation</span> therapy directly and specifically to cancer cells.</li> <li class="seamTextUnorderedListItem">225Ac-DOTATATE (RYZ101) is an experimental radiopharmaceutical or radioactive drug.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of <span class="highlight">immunotherapy</span> 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">Somatostatin receptors (SSTRs) are a type of biomarker your tumor may have. Ask your doctor and/or check your pathology report to know if your cancer expresses somatostatin receptors (SSTRs).</li> <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">In this trial, HER2 low is defined as IHC 1+ or IHC 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/NCT06590857' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/radiopharmaceuticals-cancer-radiation-therapy#:~:text=Once%20a%20radiopharmaceutical%20has%20stuck,irreparably%20damaged%2C%20that%20cell%20dies' target='_blank'>National Cancer Institute: Radiopharmaceuticals</a> </li></ul>
2

RYZ101 Radioactive Drug with <span class="highlight">Immunotherapy</span> for Advanced ER+, HER2- Breast Cancer Expressing SSTRs

Phase 1b/2 Open-label Trial of 225Ac-DOTATATE (RYZ101) Alone and in Combination with Pembrolizumab in Subjects with Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) and Progressed After Antibody-drug Conjugates And/or Chemotherapy (TRACY-1)
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Nearest Location:
339 miles
Research Facility
Santa Monica, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06590857

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Phase I-II

3

<span class="highlight">Immunotherapy</span> and <span class="highlight">Radiation</span> Therapy for Metastatic HER2 Negative Breast Cancer

A Phase I Study of In Situ Immunomodulation With CDX-301, Radiotherapy, CDX-1140, and Poly-ICLC in Patients With Unresectable and Metastatic Solid Tumors With Injectable Palpable Disease

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of CDX-301, CDX-1140, and Poly ICLC (Hiltonol®) immunotherapies with <span class="highlight">radiation</span> therapy.

Who is this for?: People with metastatic (stage IV) HER2 negative (HER2-) breast cancer 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">CDX-301, by injection, 5 days every 3 weeks for 3 months</li> </ul> <p class="seamTextPara"> followed 3-4 days later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation, 1 day every 3 weeks for 3 months</li> </ul> <p class="seamTextPara"> followed 1 day later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-1140, by infusion and/or injection, 1 day every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Poly ICLC (Hiltonol®), by injection, 1 day every 3 weeks for 3 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301 is an experimental <span class="highlight">immunotherapy</span> called a Flt3 agonist, which means it binds to Flt3 on immune cells to target and kill cancer cells.</li> <li class="seamTextUnorderedListItem">CDX-1140 is an experimental <span class="highlight">immunotherapy</span> called a CD40 agonist, which means it binds to CD40 on immune cells to target and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Poly ICLC (Hiltonol®) is an <span class="highlight">immunotherapy</span> that stimulates immune cells to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">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/NCT04616248' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/recombinant-flt3-ligand' target='_blank'>National Cancer Institute: CDX-301</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-cd40-agonist-monoclonal-antibody-cdx-1140' target='_blank'>National Cancer Institute: CDX-1140</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/poly-iclc' target='_blank'>National Cancer Institute: Poly ICLC (Hiltonol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncovir.com/science' target='_blank'>Oncovir: Poly ICLC (Hiltonol®) Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li></ul>
3

<span class="highlight">Immunotherapy</span> and <span class="highlight">Radiation</span> Therapy for Metastatic HER2 Negative Breast Cancer

A Phase I Study of In Situ Immunomodulation With CDX-301, Radiotherapy, CDX-1140, and Poly-ICLC in Patients With Unresectable and Metastatic Solid Tumors With Injectable Palpable Disease
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Nearest Location:
348 miles
USC/Norris Comprehensive Cancer Center
Los Angeles, CA

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Visits:
7 visits every 3 weeks for 3 months

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ClinicalTrials.gov: NCT04616248

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Phase I

4

<span class="highlight">Immunotherapy</span> and <span class="highlight">Radiation</span> for Advanced CEA Positive Breast Cancer

A Phase I Study of M5A-IL2 Immunocytokine Combined With Stereotactic Body <span class="highlight">Radiation</span> Therapy (SBRT) in Patients With Metastatic Colorectal Cancer or CEA-Positive Metastatic Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of M5A-IL2, an experimental <span class="highlight">immunotherapy,</span> with standard of care stereotactic body <span class="highlight">radiation</span> therapy (SBRT).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) CEA+ breast cancer 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">Stereotactic body <span class="highlight">radiation</span> therapy (SBRT), 3 sessions within 1 week</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">M5A-IL2 (M5A-ICK), by injection, 3 times within 3 days</li> <li class="seamTextUnorderedListItem">PET/CT scans</li> <li class="seamTextUnorderedListItem">MRI scans and/or bone scans</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carcinoembryonic Antigen (CEA) is a protein that is present in some cancers, including breast cancer.</li> <li class="seamTextUnorderedListItem">M5A-IL2 (M5A-ICK) is an experimental <span class="highlight">immunotherapy</span> called an immunocytokine.</li> <li class="seamTextUnorderedListItem">Immunocytokines are small proteins that regulate the activity of immune cells that are important for anti-cancer activity.</li> <li class="seamTextUnorderedListItem">The M5A-IL2 immunocytokine (M5A-ICK) combines the cancer targeting features of the M5A antibody with the immune system regulation properties of the cytokine IL-2.</li> <li class="seamTextUnorderedListItem">Stereotactic body <span class="highlight">radiation</span> therapy (SBRT) uses special equipment to position a patient and deliver <span class="highlight">radiation</span> to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.</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/NCT06130826' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/managing-cancer/treatment-types/immunotherapy/cytokines.html' target='_blank'>American Cancer Society: Cytokines</a> </li></ul>
4

<span class="highlight">Immunotherapy</span> and <span class="highlight">Radiation</span> for Advanced CEA Positive Breast Cancer

A Phase I Study of M5A-IL2 Immunocytokine Combined With Stereotactic Body <span class="highlight">Radiation</span> Therapy (SBRT) in Patients With Metastatic Colorectal Cancer or CEA-Positive Metastatic Breast Cancer
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Nearest Location:
353 miles
City of Hope Medical Center
Duarte, CA

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Visits:
At least 6 visits within 2 weeks

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ClinicalTrials.gov: NCT06130826

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Phase I

5

Single vs. Multiple Doses of <span class="highlight">Radiation</span> with <span class="highlight">Immunotherapy</span> for Breast Cancer with Brain Metastasis

Hypofractionated Radiotherapy vs Single Fraction Radiosurgery for Brain Metastasis Patients on <span class="highlight">Immunotherapy</span> (HYPOGRYPHE)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of single fraction stereotactic radiosurgery (SSRS) compared to fractionated stereotactic radiosurgery (FSRS).

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who have received or are receiving treatment with a PD-1/PD-L1 inhibitor. You must have at least 1 brain tumor that has not been treated with radiation. 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: Single <span class="highlight">Radiation</span> Dose</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Single fraction stereotactic radiosurgery (SSRS), 1 time</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Multiple <span class="highlight">Radiation</span> Doses</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fractionated stereotactic radiosurgery (FSRS), 3-5 times within 3-10 days</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic <span class="highlight">radiation</span> (stereotactic radiosurgery) delivers high-dose, precisely-targeted <span class="highlight">radiation</span> in fewer doses than traditional <span class="highlight">radiation</span> therapy.</li> <li class="seamTextUnorderedListItem">Single fraction stereotactic radiosurgery (SSRS) uses a higher dose of <span class="highlight">radiation</span> in a single dose.</li> <li class="seamTextUnorderedListItem">SSRS has recently become a standard of care treatment for people with 1-4 brain metastases and is also commonly used for people with up to 15 metastases.</li> <li class="seamTextUnorderedListItem">Fractionated stereotactic radiosurgery (FSRS) uses a lower dose of <span class="highlight">radiation</span> over 3 to 5 treatments given daily or every other day.</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/NCT05703269' 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.mayoclinic.org/tests-procedures/stereotactic-radiosurgery/about/pac-20384526' target='_blank'>Mayo Clinic: Stereotactic Radiation</a> </li></ul>
5

Single vs. Multiple Doses of <span class="highlight">Radiation</span> with <span class="highlight">Immunotherapy</span> for Breast Cancer with Brain Metastasis

Hypofractionated Radiotherapy vs Single Fraction Radiosurgery for Brain Metastasis Patients on <span class="highlight">Immunotherapy</span> (HYPOGRYPHE)
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Nearest Location:
895 miles
Lovelace Medical Center-Saint Joseph Square
Albuquerque, NM

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Visits:
1-5 visits within 1-2 weeks

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ClinicalTrials.gov: NCT05703269

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Phase NA

6

Targeted Therapy, Radiation, Chemotherapy, and <span class="highlight">Immunotherapy</span> for Metastatic Triple Negative or HER2-, BRCA Mutated Breast Cancer with Brain Metastases

Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (Olaparib) Followed by Adjuvant Combination of Durvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of olaparib (Lynparza®) PARP inhibitor, stereotactic radiosurgery, chemotherapy, and durvalumab (Imfinzi®) PD-L1 inhibitor.

Who is this for?: Postmenopausal women or men with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer or HER2 negative (HER2-) breast cancer that has spread to the brain (brain metastasis). If you have HER2- breast cancer, you must also have a germline (inherited) or somatic (tumor) BRCA mutation. You must have at least 1 brain tumor that has not been treated with radiation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily for 1 month</li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS), 1-5 times</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy: Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), eribulin (Halaven®), carboplatin (Paraplatin®), cisplatin (Platinol®), capecitabine (Xeloda®), or gemcitabine (Gemzar®)</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Stereotactic <span class="highlight">radiation</span> (stereotactic radiosurgery) delivers high-dose, precisely-targeted <span class="highlight">radiation</span> in fewer doses than traditional <span class="highlight">radiation</span> therapy.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), eribulin (Halaven®), carboplatin (Paraplatin®), cisplatin (Platinol®), capecitabine (Xeloda®), or gemcitabine (Gemzar®) are chemotherapy drugs that slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of <span class="highlight">immunotherapy</span> called a PD-L1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA</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/NCT04711824' 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.breastcancer.org/treatment/targeted-therapy/lynparza' target='_blank'>Breastcancer.org: Olaparib (Lynparza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/stereotactic-radiosurgery/about/pac-20384526' target='_blank'>Mayo Clinic: Stereotactic Radiosurgery</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://medlineplus.gov/druginfo/meds/a617030.html' target='_blank'>MedlinePlus: Durvalumab (Imfinzi®)</a> </li></ul>
6

Targeted Therapy, Radiation, Chemotherapy, and <span class="highlight">Immunotherapy</span> for Metastatic Triple Negative or HER2-, BRCA Mutated Breast Cancer with Brain Metastases

Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (Olaparib) Followed by Adjuvant Combination of Durvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases
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Nearest Location:
1946 miles
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, IN

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04711824

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Phase I-II

7

Palliative <span class="highlight">Radiation</span> and <span class="highlight">Immunotherapy</span> for People with Metastatic Breast Cancer

A Phase 2 Study of Palliative <span class="highlight">Radiation</span> in Combination With Pembrolizumab in Subjects With Unresectable Metastatic Stage IV Breast Cancer: Twisted Pink

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of stereotactic <span class="highlight">radiation</span> with pembrolizumab (Keytruda®) <span class="highlight">immunotherapy.</span>

Who is this for?: Women with stage IV (metastatic) breast cancer who have received at least 2 lines of therapy, including 1 line of chemotherapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation, 1-5 sessions</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic <span class="highlight">radiation</span> (stereotactic radiosurgery) delivers high-dose, precisely-targeted <span class="highlight">radiation</span> in fewer doses than traditional <span class="highlight">radiation</span> therapy.</li> <li class="seamTextUnorderedListItem">Palliative <span class="highlight">radiation</span> reduces side effects of metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of <span class="highlight">immunotherapy</span> 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">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/NCT04990921' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncolink.org/support/hospice-and-palliative-care/palliative-radiation-treatment#:~:text=Palliative%20radiation%20is%20the%20use,doses)%20than%20traditional%20radiation%20treatment.' target='_blank'>OncoLink: Palliative Radiation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
7

Palliative <span class="highlight">Radiation</span> and <span class="highlight">Immunotherapy</span> for People with Metastatic Breast Cancer

A Phase 2 Study of Palliative <span class="highlight">Radiation</span> in Combination With Pembrolizumab in Subjects With Unresectable Metastatic Stage IV Breast Cancer: Twisted Pink
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Nearest Location:
1984 miles
James Graham Brown Cancer Center
Louisville, KY

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT04990921

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Phase II

8

Radiation, <span class="highlight">Immunotherapy</span> and a PARP Inhibitor for Advanced Triple-Negative or ER Low Breast Cancer

A Phase II Study of NirAparib, Dostarlimab and Radiotherapy in Metastatic, PD-L1 Negative or <span class="highlight">Immunotherapy-Refractory</span> Triple-Negative Breast Cancer (NADiR)

Purpose: To study the safety and anti-cancer activity of giving <span class="highlight">radiation</span> therapy with a PARP inhibitor and a PD-1 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer. You must not have received more than two systemic therapies for advanced disease and you must not have a BRCA 1/2 mutation (inherited or tumor). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®), by IV, every 3 weeks for 3 months, then every 6 weeks, ongoing</li> <li class="seamTextUnorderedListItem"><span class="highlight">Radiation</span> therapy, 3 times, during the first week of treatment</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low. This trial is enrolling people with triple-negative as well as ER Low breast cancer. </li> <li class="seamTextUnorderedListItem">Niraparib (Zejula®)is a type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA. It is considered an experimental drug in this trial. </li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®) is an experimental PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">PD-1 inhibitors are a type of <span class="highlight">immunotherapy</span> also called a checkpoint inhibitor. They work by getting the immune system to go after cancer cells by blocking the PD-1 protein.</li> <li class="seamTextUnorderedListItem">An experimental therapy is a drug approved by the FDA for studying in people in clinical trials. A drug may be FDA approved for use in one disease but still considered experimental for use in breast cancer. </li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Researchers believe that <span class="highlight">radiation</span> therapy may also boost the immune system, which will help the immune system go after 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/NCT04837209' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/blog/triple-negative-breast-cancer-treatment-symptoms-research' target='_blank'>BCRF: Triple-Negative Breast Cancer: Symptoms, Treatment, Research</a> </li></ul>
8

Radiation, <span class="highlight">Immunotherapy</span> and a PARP Inhibitor for Advanced Triple-Negative or ER Low Breast Cancer

A Phase II Study of NirAparib, Dostarlimab and Radiotherapy in Metastatic, PD-L1 Negative or <span class="highlight">Immunotherapy-Refractory</span> Triple-Negative Breast Cancer (NADiR)
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Nearest Location:
2385 miles
Duke University Medical Center
Durham, NC

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Visits:
3 visits for the first week, then every 3 weeks for 3 months, then every 6 weeks, ongoing

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ClinicalTrials.gov: NCT04837209

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Phase II

9

<span class="highlight">Radiation</span> Therapy, <span class="highlight">Immunotherapy,</span> and a PARP Inhibitor for Women with Advanced Triple Negative Breast Cancer

A Phase II Study of Pembrolizumab and Ablative Radiotherapy With or Without Olaparib in Metastatic Triple-Negative Breast Cancers : Initial Test Cohorts of a Platform Trial to Sequentially Investigate Combinations of DNA-Damage Response Inhibitors and <span class="highlight">Immunotherapy</span> for the Augmentation of Immune Responses

Purpose: To study the safety and anti-cancer activity of using <span class="highlight">radiation</span> therapy and the <span class="highlight">immunotherapy</span> pembrolizumab (Keytruda®) with or without the PARP inhibitor olaparib (Lynparza®).

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not already received a PARP inhibitor or more than two systemic therapies for advanced disease. To enroll, you must not have a BRCA 1/2 mutation (inherited or tumor). 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</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, 3 times</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice a day, for 6 weeks</li> <li class="seamTextUnorderedListItem"><span class="highlight">Radiation</span> therapy, daily, for five days</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, 3 times</li> <li class="seamTextUnorderedListItem"><span class="highlight">Radiation</span> therapy, daily, for five days</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of <span class="highlight">immunotherapy</span> called a checkpoint inhibitor or PD-1 inhibitor. It helps the immune system to go after cancer cells by blocking the PD-1 protein.</li> <li class="seamTextUnorderedListItem">Pembrolizumab is approved to treat some advanced triple-negative breast cancer, but its use in this trial, however, is considered experimental.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a PARP inhibitor. It works by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Olaparib is approved to treat HER2-negative metastatic breast cancer in women with an inherited BRCA1/2 mutation. Its use in this trial, however, is considered experimental. </li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to kill tumor cells and shrink 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/NCT04683679' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/tnbc-treatment-update-2021/' target='_blank'>Metastatic Trial Talk: 2021 Update on Metastatic Triple-Negative Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/cancerwise/does-immunotherapy-treat-breast-cancer.h00-159385101.html' target='_blank'>MD Anderson Cancer Center: Does Immunotherapy Treat Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/fda-approves-keytruda-for-pd-l1-pos-tnbc' target='_blank'>Breastcancer.org: FDA Approves Immunotherapy Keytruda for PD-L1-Positive Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/targeted-cancer-drugs/types/PARP-inhibitors' target='_blank'>Cancer Research UK: PARP Inhibitors</a> </li></ul>
9

<span class="highlight">Radiation</span> Therapy, <span class="highlight">Immunotherapy,</span> and a PARP Inhibitor for Women with Advanced Triple Negative Breast Cancer

A Phase II Study of Pembrolizumab and Ablative Radiotherapy With or Without Olaparib in Metastatic Triple-Negative Breast Cancers : Initial Test Cohorts of a Platform Trial to Sequentially Investigate Combinations of DNA-Damage Response Inhibitors and <span class="highlight">Immunotherapy</span> for the Augmentation of Immune Responses
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Nearest Location:
2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, NJ

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Visits:
8 visits over 2 months

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ClinicalTrials.gov: NCT04683679

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Phase II

10

Pembrolizumab (Immunotherapy) And Radiosurgery (Radiation) to Treat Brain Metastases

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients

Purpose: To study the safety and effects (good and bad) of using pembrolizumab (Keytruda®) along with stereotactic radiosurgery (SRS) to treat breast cancer that has spread to the brain.

Who is this for?: Women with metastatic (stage IV) breast cancer and at least two brain metastases. 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, once every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Stereotactic Radiosurgery (SRS), once after the first treatment of pembrolizumab</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Keytruda is a type of <span class="highlight">immunotherapy</span> called a PD-1 inhibitor.</li> <li class="seamTextUnorderedListItem">It stimulates the body's immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">It has been approved to treat certain types of cancer, but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery is not surgery. It is a type of <span class="highlight">radiation</span> therapy that precisely targets metastases in the brain.</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/NCT03449238' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/brain-mets/' target='_blank'>Metastatic Breast Cancer Network: Brain Metastases</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/types/recur_metast/treat_metast/options/local/brain/radiosurgery' target='_blank'>Breastcancer.org: Stereotactic Radiosurgery for Brain Metastasis</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/what' target='_blank'>Breastcancer.org: What is Immunotherapy?</a> </li></ul>
10

Pembrolizumab (Immunotherapy) And Radiosurgery (Radiation) to Treat Brain Metastases

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
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Nearest Location:
2567 miles
Weill Cornell Medicine
New York, NY

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Visits:
1 visit every 3 weeks, ongoing

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ClinicalTrials.gov: NCT03449238

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Phase I-II

11

<span class="highlight">Immunotherapy</span> Vaccine, <span class="highlight">Radiation</span> and Pembrolizumab for Metastatic Breast Cancer

In Situ Vaccination With Flt3L, Radiation, and Poly-ICLC Combined With Pembrolizumab in Patients With Non-Hodgkin's Lymphoma, Metastatic Breast Cancer, and Head and Neck Squamous Cell Carcinoma

Purpose: To test the safety and effects (good and bad) of an experimental <span class="highlight">immunotherapy</span> injected into metastases when combined with <span class="highlight">radiation</span> and pembrolizumab (Keytruda®).

Who is this for?: People with 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">Pembrolizumab (Keytruda®), by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Flt3L(CDX-301), by injection</li> <li class="seamTextUnorderedListItem">Radiation, 2 small treatments, on day 1 and day 2</li> <li class="seamTextUnorderedListItem">Poly ICLC (Hiltonol), by injection </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">The immunotherapies injected into the metastases are flt3L and poly-ICLC. </li> <li class="seamTextUnorderedListItem">Flt3L is an immune cell growth factor. It gets the body to make more immune cells. </li> <li class="seamTextUnorderedListItem">Poly-ICLC is an immune cell activating factor. It turns on the immune cells that have been brought to the tumor by flt3L. </li> <li class="seamTextUnorderedListItem">Radiation therapy will be targeted at the same metastases as these immunotherapies.</li> <li class="seamTextUnorderedListItem">Keytruda is a type of <span class="highlight">immunotherapy</span> called a PD-1 inhibitor that is given intravenously (IV). It stimulates the body's immune system to go after cancer cells. It is approved to treat more than 10 types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients 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/NCT03789097' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.celldex.com/pipeline/cdx-301.php' target='_blank'>Drug company information page: CDX-301</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/poly-iclc' target='_blank'>NCI Drug Dictionary: poly ICLC</a> </li></ul>
11

<span class="highlight">Immunotherapy</span> Vaccine, <span class="highlight">Radiation</span> and Pembrolizumab for Metastatic Breast Cancer

In Situ Vaccination With Flt3L, Radiation, and Poly-ICLC Combined With Pembrolizumab in Patients With Non-Hodgkin's Lymphoma, Metastatic Breast Cancer, and Head and Neck Squamous Cell Carcinoma
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Nearest Location:
2569 miles
Icahn School of Medicine at Mount Sinai
New York, NY

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Visits:
At least 1 visit every 3 weeks

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ClinicalTrials.gov: NCT03789097

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Phase I-II

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