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1

Fulvestrant Alone or With Binimetinib Targeted Therapy for Metastatic HR+, HER2- Breast Cancer with a NF1 Mutation

A ComboMATCH Treatment Trial EAY191-N2: Phase 2 Trial of Fulvestrant and Binimetinib in Patients With Hormone Receptor-Positive Metastatic Breast Cancer With a Frameshift or Nonsense Mutation or Genomic Deletion in NF1

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of fulvestrant (Faslodex®) hormone therapy alone or with binimetinib (Mektovi®) MEK inhibitor.

Who is this for?: People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a NF1 mutation who have received treatment with a CDK 4/6 inhibitor. You must not have received more than 1 line of chemotherapy for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> <li class="seamTextUnorderedListItem">Binimetinib (Mektovi®), by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CT, MRI, or <span class="highlight">bone</span> scan, 2 times</li> <li class="seamTextUnorderedListItem">Biopsy, 2 times</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">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors, which may inhibit the growth of estrogen-sensitive tumor cells.</li> <li class="seamTextUnorderedListItem">Binimetinib (Mektovi®) is a type of targeted therapy called a MEK inhibitor that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.</li> <li class="seamTextUnorderedListItem">Targets or mutations: NF1</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/NCT05554354' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a618041.html' target='_blank'>Medline Plus: Binimetinib (Mektovi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex#:~:text=Faslodex%20(chemical%20name%3A%20fulvestrant),%2C%20HER2%2Dnegative%20breast%20cancer.' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
1

Fulvestrant Alone or With Binimetinib Targeted Therapy for Metastatic HR+, HER2- Breast Cancer with a NF1 Mutation

A ComboMATCH Treatment Trial EAY191-N2: Phase 2 Trial of Fulvestrant and Binimetinib in Patients With Hormone Receptor-Positive Metastatic Breast Cancer With a Frameshift or Nonsense Mutation or Genomic Deletion in NF1
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Nearest Location:
8 miles
Epic Care Partners in Cancer Care
Emeryville, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05554354

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Phase II

2

Paclitaxel Alone or With Radium-223 Dichloride For Metastatic HER2 Negative Breast Cancer With <span class="highlight">Bone</span> Metastases

Phase II Trial of Radium-223 Dichloride in Combination With Paclitaxel in Patients With <span class="highlight">Bone</span> Metastatic Breast Cancer

Purpose: To study the anti-cancer activity and effects (good and bad) of giving radium-223 dichloride (a type of radiation therapy given by IV) in combination with paclitaxel (Taxol®).

Who is this for?: People with metastatic (stage IV), HER2 negative (HER2-) breast cancer that has spread to the <span class="highlight">bone</span> and who have not received more than three lines of 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: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Radium 223 dichloride (Xofigo®), by IV, once a month, for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off), ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug routinely used to treat metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">Radium-223 dichloride (Xofigo®) is a radiation therapy given by IV. It works by killing cancer cells and may reduce the pain caused by <span class="highlight">bone</span> metastases. </li> <li class="seamTextUnorderedListItem">Radium-223 dichloride (Xofigo®) is approved to treat metastatic prostate cancer that has spread to the <span class="highlight">bones.</span> Its use in breast cancer is considered experimental.</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/NCT04090398' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/oral-vs-iv-paclitaxel-for-mbc' target='_blank'>Breastcancer.org: Is Oral Paclitaxel Better Than IV Paclitaxel for Metastatic Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/radium-223-dichloride.aspx' target='_blank'>Chemocare: Radium 223 Dichloride</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Radium-223' target='_blank'>Wikipedia: Radium-223</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/bone-mets/' target='_blank'>Metastatic Breast Cancer Network: Bone Mets</a> </li></ul>
2

Paclitaxel Alone or With Radium-223 Dichloride For Metastatic HER2 Negative Breast Cancer With <span class="highlight">Bone</span> Metastases

Phase II Trial of Radium-223 Dichloride in Combination With Paclitaxel in Patients With <span class="highlight">Bone</span> Metastatic Breast Cancer
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Nearest Location:
74 miles
University of California Davis Comprehensive Cancer Center
Sacramento, CA

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Visits:
3 visits a month, ongoing

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ClinicalTrials.gov: NCT04090398

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Phase II

3

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>
3

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

4

Immunotherapy, Chemotherapy, and Targeted Therapy for Advanced Triple Negative Breast Cancer

ToPCourT: A Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of pembrolizumab (Keytruda®) PD-1 inhibitor, gemcitabine (Gemzar®) and carboplatin (Paraplatin®) chemotherapy, and trilaciclib (Cosela®) CDK4/6 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer. You must not have received more than 3 lines of chemotherapy 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">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®), by IV, weekly, 2 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <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">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®) also helps protect the <span class="highlight">bone</span> marrow from the side effects of chemotherapy.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</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/NCT06027268' target='_blank'>ClinicalTrials.gov</a> </li></ul>
4

Immunotherapy, Chemotherapy, and Targeted Therapy for Advanced Triple Negative Breast Cancer

ToPCourT: A Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)
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Nearest Location:
2299 miles
Levine Cancer Institute
Charlotte, NC

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Visits:
1 visit every 1-2 weeks

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ClinicalTrials.gov: NCT06027268

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Phase II

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/nceh/radiation/dexa-scan.html#:~:text=DEXA%20(dual%20x%2Dray%20absorptiometry,the%20hip%20and%20the%20spine.' 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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