Breast Cancer Clinical Trial

Gut and Tumor Microbiome in Patients With Early Stage (II-III), Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer.

Summary

The purpose of this research study is to collect samples of blood and stool and analyse primary tumor from participants with breast cancer or melanoma to see how the bacteria in the body affect cancer and how well it responds to treatment. By comparing samples and data from multiple participants with breast cancer or melanoma, it may be possible to identify how a person's gut health and tumor microenvironment affects how they respond to certain cancer treatments.

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Full Description

After being informed about the study and potential risks, all participants giving written informed consent will provide a pre-treatment stool sample looking at the gut microbiome, primary tumor sequencing analysis to infer tumor microbiome, and a blood sample for the CyTOF whole blood Immune Profile. Blood tests (full blood count, renal profile, liver profile, C-reactive protein), medical history, concomitant medications, and the Eastern Cooperative Oncology Group (ECOG) performance level will be obtained through a mixture of self-reported and data collated from the electronic health record (EHR). Two food frequency questionnaires will be given to participants to complete at two timepoints: at screening and at end of study. There are 5 study visits. Participants will provide a stool sample for gut microbiome sequencing at weeks 2 and 4 of the study. During the Week 6 visit, participants will provide final stool samples for gut microbiome analysis, and a blood sample for CyTOF whole blood Immune Profile. ECOG performance status and adverse event data will be obtained from EHR.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Arm-1: Early stage (II-III), locally advanced or advanced ER-positive and HER2-negative Breast Cancer

Signed, written, voluntary, and informed consent
Histological confirmation of early stage (II-III) locally advanced or advanced ER positive and HER2 negative breast cancer
Tumor DNA sequencing has been completed by selected NGS vendor(s) at the time of or prior to treatment initiation
Female participants between 18 - 85 years of age
ECOG performance status that is equal to 0 or 1 at the time of screening.
Must be willing to provide blood for immune profile analysis on study enrollment and at specified study time points
Must be willing and able to perform stool sample collection
Participants due to receive standard of care CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) in combination with endocrine therapy

Exclusion Criteria:

Arm-1: Early stage (II-III), locally advanced or advanced ER-positive and HER2-negative Breast Cancer

Adult males
Mental incapacity, as determined by an investigator
Participant is pregnant, breastfeeding, or plans to become pregnant during the course of the study
Experiencing active brain metastasis/metastases
Active participation in an immuno-oncology or interventional clinical trial
Participation in any experimental trial in the 3 months prior to screening
Participant has relapsed on prior endocrine therapy for this instance of cancer, or has discontinued any prior adjuvant endocrine therapy within 6 months of screening
History of inflammatory bowel disease, chronic diarrhea or malabsorption syndromes, or significant prior bowel resection as judged by the study investigator
Use of immunosuppressants, including steroids, within 4 weeks of the first sample collection
Oral or intravenous antibiotic usage within 3 months of the first sample collection

Study is for people with:

Breast Cancer

Estimated Enrollment:

24

Study ID:

NCT06126003

Recruitment Status:

Recruiting

Sponsor:

BioCorteX Inc

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There are 6 Locations for this study

See Locations Near You

Cancer Care Specialists of Illinois
Decatur Illinois, 62526, United States More Info
Kaitlynn Zeisset
Contact
618-416-7970
[email protected]
James Wade, MD
Principal Investigator
OptumCare Cancer Care
Las Vegas Nevada, 89102, United States More Info
Danielle Handy
Contact
[email protected]
Khawaja Jahangir, MD
Principal Investigator
New Jersey Cancer Care, PA
Belleville New Jersey, 07042, United States More Info
Michael Johnstone
Contact
973-751-8880
[email protected]
James Orsini, MD
Principal Investigator
Cayuga Medical Center
Ithaca New York, 14850, United States More Info
Danielle Rao
Contact
[email protected]
Anthony Mato, MD
Principal Investigator
Toledo Clinic Cancer Center
Toledo Ohio, 43623, United States More Info
Pam Shoup
Contact
419-214-4236
[email protected]
Rex Mowat, MD
Principal Investigator
Valley Cancer Associates, PA
Harlingen Texas, 78550, United States More Info
Elyssa Navarro
Contact
956-608-6719
[email protected]
Todd Shenkenberg, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

24

Study ID:

NCT06126003

Recruitment Status:

Recruiting

Sponsor:


BioCorteX Inc

How clear is this clinincal trial information?

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