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1

Immunotherapy and Radiation for Advanced CEA Positive Breast Cancer

A Phase I Study of M5A-IL2 Immunocytokine Combined With Stereotactic Body Radiation 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 immunotherapy, with standard of care stereotactic body radiation 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 radiation 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 <span class="highlight">bone</span> 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 immunotherapy 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 radiation therapy (SBRT) uses special equipment to position a patient and deliver radiation 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>
1

Immunotherapy and Radiation for Advanced CEA Positive Breast Cancer

A Phase I Study of M5A-IL2 Immunocytokine Combined With Stereotactic Body Radiation 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

2

CycloSam <span class="highlight">Bone-Targeting</span> Radioactive Drug for Metastatic Breast Cancer with <span class="highlight">Bone</span> Metastases

A Dose Finding Study of CycloSam® (153-Sm-DOTMP) to Treat Solid Tumor(s) in the <span class="highlight">Bone</span> or Metastatic to the <span class="highlight">Bone</span> (Metastatic Prostate, Breast, and Lung, Osteosarcoma, Ewing's Sarcoma, and Other Solid Tumor(s) to the <span class="highlight">Bone</span> All Eligible)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of CycloSam®, an experimental radioactive drug.

Who is this for?: People with stage IV (metastatic) breast cancer that has spread to the <span class="highlight">bone</span> 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">CycloSam®, by IV, 2 times within 1 week</li> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CycloSam®, also known as 153-Sm-DOTMP, is an experimental radiation therapy drug called a radiopharmaceutical or radioactive drug.</li> <li class="seamTextUnorderedListItem">CycloSam® travels to the <span class="highlight">bone</span> and delivers radiation only to tumors in the <span class="highlight">bone.</li></span> <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/NCT06008483' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://qsambio.com/cyclosam/' target='_blank'>QSAM Biosciences: What is CycloSam®?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/metastatic/bone-metastasis' target='_blank'>Breastcancer.org: Metastasis to the Bone</a> </li></ul>
2

CycloSam <span class="highlight">Bone-Targeting</span> Radioactive Drug for Metastatic Breast Cancer with <span class="highlight">Bone</span> Metastases

A Dose Finding Study of CycloSam® (153-Sm-DOTMP) to Treat Solid Tumor(s) in the <span class="highlight">Bone</span> or Metastatic to the <span class="highlight">Bone</span> (Metastatic Prostate, Breast, and Lung, Osteosarcoma, Ewing's Sarcoma, and Other Solid Tumor(s) to the <span class="highlight">Bone</span> All Eligible)
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Nearest Location:
1634 miles
Clinical Trial Site
Houston, TX

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Visits:
2 visits within 1 week

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ClinicalTrials.gov: NCT06008483

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Phase I

3

Blood Test to Understand How <span class="highlight">Bone</span> Marrow Cells Affect Breast Cancer

Megakaryocytes and Platelets, Harmful or Helpful in Breast Cancer Cell Metastasis

Purpose: To study the relationship between cells in the <span class="highlight">bone</span> marrow that make platelets and breast cancer cells.

Who is this for?: Women newly diagnosed with stage 0 (DCIS or LCIS), stage I, stage II, stage III, or stage IV (metastatic) breast cancer who have not yet received treatment, as well as women without breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood sample, 1 time</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Platelets are needed for blood clotting.</li> <li class="seamTextUnorderedListItem">Platelets and the cells in the <span class="highlight">bone</span> marrow that make them may be helpful or harmful in breast cancer and the spread of 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/NCT06011824' target='_blank'>ClinicalTrials.gov</a> </li></ul>
3

Blood Test to Understand How <span class="highlight">Bone</span> Marrow Cells Affect Breast Cancer

Megakaryocytes and Platelets, Harmful or Helpful in Breast Cancer Cell Metastasis
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Nearest Location:
1675 miles
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, WI

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Visits:
1 visit

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ClinicalTrials.gov: NCT06011824

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Phase NA

4

Abemaciclib CDK4/6 Inhibitor with Radiation for People with Metastatic HR+, HER2- Breast Cancer with <span class="highlight">Bone</span> Metastases

A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Breast Cancer

Purpose: To test different doses of abemaciclib (Verzenio®) CDK4/6 inhibitor to find the best dose in people receiving radiation.

Who is this for?: People with metastatic (stage IV) hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2-) breast cancer with <span class="highlight">bone</span> metastases who are planning to receive radiation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth</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 enzymes, CDK4 and CDK6, that help cancer grow.</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/NCT06678269' target='_blank'>ClinicalTrials.gov</a> </li></ul>
4

Abemaciclib CDK4/6 Inhibitor with Radiation for People with Metastatic HR+, HER2- Breast Cancer with <span class="highlight">Bone</span> Metastases

A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Breast Cancer
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Nearest Location:
2539 miles
Memorial Sloan Kettering at Basking Ridge (All protocol activities)
Basking Ridge, NJ

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06678269

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Phase I

5

Studying <span class="highlight">Bone</span> Changes in Post-Menopausal Women with Stage I-IV Breast Cancer After Treatment with Aromatase Inhibitor and Denosumab

Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors and Denosumab: An Observational Study to Assess Rebound <span class="highlight">Bone</span> Loss and Insufficiency Fractures After Denosumab Discontinuation

Purpose: To gather information about changes in the <span class="highlight">bones</span> after stopping treatment with an aromatase inhibitor and denosumab (Xgeva®).

Who is this for?: Postmenopausal women with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who have completed treatment with an aromatase Inhibitor before or within 6 months of completing at least 2 doses of denosumab (Xgeva®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physical exam, 5 visits within 2 years</li> <li class="seamTextUnorderedListItem">DEXA scan, 2 times within 2 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The physical exam will include history and pain assessment for development of new fractures, weight and height measurement with BMI (body mass index) calculation, and blood work.</li> <li class="seamTextUnorderedListItem">Dual-energy X-ray absorptiometry (DEXA) scans use x-ray energy to measure <span class="highlight">bone</span> density (thickness and strength of <span class="highlight">bones).</li></ul></span>

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/NCT05590949' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cdc.gov/radiation-health/data-research/facts-stats/dexa-scan.html' target='_blank'>CDC: DEXA Scan</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a610023.html' target='_blank'>MedlinePlus: Denosumab (Xgeva®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li></ul>
5

Studying <span class="highlight">Bone</span> Changes in Post-Menopausal Women with Stage I-IV Breast Cancer After Treatment with Aromatase Inhibitor and Denosumab

Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors and Denosumab: An Observational Study to Assess Rebound <span class="highlight">Bone</span> Loss and Insufficiency Fractures After Denosumab Discontinuation
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Nearest Location:
2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, NJ

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Visits:
5 visits

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ClinicalTrials.gov: NCT05590949

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Phase NA

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