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

NCT06126003 | Terminated

• 1 other identifier: BIOMAP-201
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Microbiome data obtained from fecal samples will be compared using alpha and beta diversity metrics.

  Screening, week 2, week 4, week 6

Study Arms (1)

Arm 1: Advanced ER-positive and HER2-negative Breast Cancer

Advanced ER+ and HER2- breast cancer participants due to receive standard of care CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) in combination with endocrine therapy.

Other: Observation

Interventions

Observation OTHER

No Intervention

Arm 1: Advanced ER-positive and HER2-negative Breast Cancer

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Only females are allowed to participate in Arm-1.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• BioCorteX Inc: lead
• Tempus AI: collaborator

Study Sites (6)

Cancer Care Specialists of Illinois

Decatur, Illinois, 62526, United States

Location

OptumCare Cancer Care

Las Vegas, Nevada, 89102, United States

Location

New Jersey Cancer Care, PA

Belleville, New Jersey, 07042, United States

Location

Cayuga Medical Center

Ithaca, New York, 14850, United States

Location

Toledo Clinic Cancer Center

Toledo, Ohio, 43623, United States

Location

Valley Cancer Associates, PA

Harlingen, Texas, 78550, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Nik Sharma, PhD

  BioCorteX Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: December 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)