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

Stopped early

Conditions studied: Breast Cancer

In brief

The purpose of this research study is to collect samples of blood and stool and analyse primary tumor from participants with breast cancer 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, it may be possible to identify how a person's gut health and tumor microenvironment affects how they respond to certain cancer treatments.

Key facts

Study ID

NCT06126003

Run by

BioCorteX Inc

People needed

2

Starts

2023-12-01

Expected to finish

2024-07-31

Last updated by the study team

2024-08-02

Who can join

Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cancer Care Specialists of Illinois — Decatur, Illinois, United States
• OptumCare Cancer Care — Las Vegas, Nevada, United States
• New Jersey Cancer Care, PA — Belleville, New Jersey, United States
• Cayuga Medical Center — Ithaca, New York, United States
• Toledo Clinic Cancer Center — Toledo, Ohio, United States
• Valley Cancer Associates, PA — Harlingen, Texas, United States

Full record on ClinicalTrials.gov

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