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1

Stool and Blood Sample Bank to Develop New Treatments for Triple Negative Breast Cancer

ARGONAUT: Development and Analysis of a Blood and Stool Sample Bank for Cancer Patients, Enabling the Systematic Study of the Effect of Gut <span class="highlight">Microbiomes</span> on Response to Treatment

Purpose: To collect stool and blood samples to study gut <span class="highlight">microbiomes,</span> study cancer biomarkers, and develop new treatments.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer planning to receive their next treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stool and blood samples, 2 times within 6 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stool samples will be used to study your gut <span class="highlight">microbiome,</span> which are the microorganisms that live in your digestive system. Drugs that target your <span class="highlight">microbiome</span> may be helpful to treat cancer.</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/NCT04638751' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healthline.com/nutrition/gut-microbiome-and-health' target='_blank'>Healthline: Gut Microbiome</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aiche.org/resources/publications/cep/2020/october/developing-precision-microbiome-medicines' target='_blank'>American Institute of Chemical Engineers: Developing Precision Microbiome Medicines</a> </li></ul>
1

Stool and Blood Sample Bank to Develop New Treatments for Triple Negative Breast Cancer

ARGONAUT: Development and Analysis of a Blood and Stool Sample Bank for Cancer Patients, Enabling the Systematic Study of the Effect of Gut <span class="highlight">Microbiomes</span> on Response to Treatment
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Nearest Location:
377 miles
Knowledge Research Center
Orange, CA

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Visits:
2 times within 6 months, then 3 times within 2 years

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ClinicalTrials.gov: NCT04638751

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Phase NA

2

Fecal Microbiota Transplantation for Immunotherapy-Related Diarrhea or Colitis in People with Stage I-IV Breast Cancer

Fecal Microbiota Transplantation (FMT) for Immune-Checkpoint Inhibitor Induced-Diarrhea/Colitis in Genitourinary Cancer Patients

Purpose: To study the ability of a fecal microbiota transplantation to improve immune checkpoint inhibitor-related diarrhea and colitis.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who developed diarrhea and/or colitis after receiving treatment with dostarlimab (Jemperli®) or pembrolizumab (Keytruda®) immune checkpoint inhibitors. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Loperamide, by mouth, 1 time</li> </ul> <p class="seamTextPara"> followed 4 hours later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fecal microbiota transplantation during colonoscopy, 1 time</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A fecal microbiota transplantation consists of taking healthy bacteria (microbiota or <span class="highlight">microbiome)</span> from the feces or stool of a healthy donor and transferring them to the colon of the recipient during a colonoscopy.</li> <li class="seamTextUnorderedListItem">A colonoscopy is a procedure in which a flexible camera is inserted through the anus to examine the colon/intestines.</li> <li class="seamTextUnorderedListItem">Loperamide is a drug used to treat diarrhea.</li> <li class="seamTextUnorderedListItem">Colitis is inflammation of the colon/intestines.</li> <li class="seamTextUnorderedListItem">Your body is home to many bacteria, viruses, and fungi, which are collectively called the <span class="highlight">microbiome.</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/NCT04038619' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2018-0663.html' target='_blank'>MD Anderson Cancer Center: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/fecal-transplant' target='_blank'>Johns Hopkins Medicine: Fecal Microbiota Transplantation</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a682280.html' target='_blank'>MedlinePlus: Loperamide</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immune Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>
2

Fecal Microbiota Transplantation for Immunotherapy-Related Diarrhea or Colitis in People with Stage I-IV Breast Cancer

Fecal Microbiota Transplantation (FMT) for Immune-Checkpoint Inhibitor Induced-Diarrhea/Colitis in Genitourinary Cancer Patients
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Nearest Location:
1644 miles
M D Anderson Cancer Center
Houston, TX

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Visits:
5 visits within 3 months

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ClinicalTrials.gov: NCT04038619

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Phase I

3

How the Gut <span class="highlight">Microbiome</span> May Affect Immunotherapy in Stage I-IV Triple Negative Breast Cancer

The Gut <span class="highlight">Microbiome</span> and Immune Checkpoint Inhibitor Therapy in Solid Tumors

Purpose: To study the gut <span class="highlight">microbiome</span> to see if it can determine if immunotherapy will be effective.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) triple negative breast cancer (ER-, PR- and HER2-) who are about to begin treatment with a checkpoint inhibitor (immunotherapy). You must speak English or Spanish. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 blood tests over 6-8 weeks</li> <li class="seamTextUnorderedListItem">2 stool samples over 6-8 weeks</li> <li class="seamTextUnorderedListItem">Questionairres (in English or Spanish)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The <span class="highlight">microbiome</span> may help determine if immunotherapy will be effective. </li> <li class="seamTextUnorderedListItem">By studying the <span class="highlight">microbiome,</span> researchers may also be able to determine if changing the <span class="highlight">microbiome</span> through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, can help the immune system fight cancer.</li> <li class="seamTextUnorderedListItem">Immunotherapies are drugs that trigger the immune system to see, go after, and kill cancer cells. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) and atezolizumab (Tecentriq®) are a type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight 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/NCT05037825' target='_blank'>ClinicalTrials.gov</a> </li></ul>
3

How the Gut <span class="highlight">Microbiome</span> May Affect Immunotherapy in Stage I-IV Triple Negative Breast Cancer

The Gut <span class="highlight">Microbiome</span> and Immune Checkpoint Inhibitor Therapy in Solid Tumors
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Nearest Location:
1986 miles
Baptist Health Clinical Research
Elizabethtown, KY

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Visits:
At least 2 visits over 6-8 weeks

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ClinicalTrials.gov: NCT05037825

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Phase NA

4

Impact of Aromatase Inhibitors on Gut Bacteria in People with Stage 0-IV Breast Cancer

Oral Aromatase Inhibitors Modify the Gut <span class="highlight">Microbiome</span> Effecting Estrogen Bioavailability

Purpose: To study the bacteria in your gut before and during treatment with an aromatase inhibitor.

Who is this for?: Women with stage 0 (DCIS), stage I, stage II, stage III, or stage IV (metastatic) hormone receptor positive (ER+ and/or PR+) breast cancer who are receiving an aromatase inhibitor, or women without breast cancer who are receiving an aromatase inhibitor to reduce their risk of breast cancer. You must not have received antibiotics within the last month. If you have HER2 positive (HER2+) breast cancer, you must not have received an antibody drug conjugate (ADC). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests, 3 times within 3 months</li> <li class="seamTextUnorderedListItem">Stool samples, 3 times within 3 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The <span class="highlight">microbiome</span> consists of the many bacteria, viruses, and fungi found in your digestive tract. Most of the <span class="highlight">microbiome</span> consists of bacteria in your digestive system.</li> <li class="seamTextUnorderedListItem">These bacteria can be beneficial or harmful. The harmful bacteria cause disease, and the beneficial bacteria help keep you healthy.</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy commonly used to treat hormone receptor-positive breast cancer. The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">You will collect fecal samples at home and either mail in the sample or drop it off at the lab.</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/NCT05030038' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hsph.harvard.edu/nutritionsource/microbiome/' target='_blank'>Harvard University: What is the Microbiome?</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/about-us/news-personal-stories/can-gut-bacteria-help-treat-breast-cancer' target='_blank'>Breast Cancer Now: Gut Bacteria and Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li></ul>
4

Impact of Aromatase Inhibitors on Gut Bacteria in People with Stage 0-IV Breast Cancer

Oral Aromatase Inhibitors Modify the Gut <span class="highlight">Microbiome</span> Effecting Estrogen Bioavailability
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Nearest Location:
2314 miles
Wake Forest Baptist Health Sciences
Winston-Salem, NC

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Visits:
3 visits in 3 months

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ClinicalTrials.gov: NCT05030038

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Phase NA

5

Registry to Study the Impact of the Gut <span class="highlight">Microbiome</span> on Brain Tumors

Study of Human Brain-Gut Axis and Gut <span class="highlight">Microbiome</span> In Patients With Brain Lesions - Repository for Neuroscience Research

Purpose: To study the impact of the gut <span class="highlight">microbiome</span> on the growth and progression of brain tumors.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive surgery. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood, tissue, saliva, urine and stool samples</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stool samples will be used to study your gut <span class="highlight">microbiome,</span> which are the microorganisms that live in your digestive system.</li> <li class="seamTextUnorderedListItem">The harmful bacteria cause disease such as infection, and the beneficial bacteria help keep you healthy.</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/NCT06117930' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
5

Registry to Study the Impact of the Gut <span class="highlight">Microbiome</span> on Brain Tumors

Study of Human Brain-Gut Axis and Gut <span class="highlight">Microbiome</span> In Patients With Brain Lesions - Repository for Neuroscience Research
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Nearest Location:
2383 miles
Mayo Clinic in Florida
Jacksonville, FL

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Visits:
Coincides with surgery and routine care

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ClinicalTrials.gov: NCT06117930

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Phase NA

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