Clinical trial NCT06126003: Gut and Tumor Microbiome in Patients With Early Stage (II-III), Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer.
Official title: A Multi-center, 2-arm Observational Study Exploring the Role of the Gut and Tumor Microbiome in the Differential Immune Profile of Patients With Early Stage (II-III), Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer (Arm-1).
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Lead sponsor: BioCorteX Inc
Sponsor class: INDUSTRY
Collaborators: name: Tempus AI
First posted: 2023-11-13
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants from the U.S. only who meet the Eligibility criteria (and no exclusion criteria) will be selected. The study will enroll at approxiumately 10 sites, including community-based cancer treatement centers and academic institutions with cancer treatment centers.

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

1. Signed, written, voluntary, and informed consent
2. Histological confirmation of early stage (II-III) locally advanced or advanced ER positive and HER2 negative breast cancer
3. Tumor DNA sequencing has been completed by selected NGS vendor(s) at the time of or prior to treatment initiation
4. Female participants between 18 - 85 years of age
5. ECOG performance status that is equal to 0 or 1 at the time of screening.
6. Must be willing to provide blood for immune profile analysis on study enrollment and at specified study time points
7. Must be willing and able to perform stool sample collection
8. 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

1. Adult males
2. Mental incapacity, as determined by an investigator
3. Participant is pregnant, breastfeeding, or plans to become pregnant during the course of the study
4. Experiencing active brain metastasis/metastases
5. Active participation in an immuno-oncology or interventional clinical trial
6. Participation in any experimental trial in the 3 months prior to screening
7. 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
8. History of inflammatory bowel disease, chronic diarrhea or malabsorption syndromes, or significant prior bowel resection as judged by the study investigator
9. Use of immunosuppressants, including steroids, within 4 weeks of the first sample collection
10. Oral or intravenous antibiotic usage within 3 months of the first sample collection

Primary outcomes:
measure: Interaction between the gut microbiome, tumor microbiome and serum immune profile for patients with early stage (II-III), locally advanced or advanced ER-positive and HER2-negative breast cancer.
timeFrame: Screening, week 2, week 4, week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Cancer Care Specialists of Illinois
state: Illinois
city: Las Vegas
country: United States
facility: OptumCare Cancer Care
state: Nevada
city: Belleville
country: United States
facility: New Jersey Cancer Care, PA
state: New Jersey
city: Ithaca
country: United States
facility: Cayuga Medical Center
state: New York
city: Toledo
country: United States
facility: Toledo Clinic Cancer Center
state: Ohio
city: Harlingen
country: United States
facility: Valley Cancer Associates, PA
state: Texas
Study officials:
affiliation: BioCorteX Inc
name: Nik Sharma, PhD
role: STUDY_DIRECTOR
References: