Status:
TERMINATED
Gut and Tumor Microbiome in Patients With Early Stage (II-III), Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer.
Lead Sponsor:
BioCorteX Inc
Collaborating Sponsors:
Tempus AI
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-85 years
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 wel...
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 sequen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT06126003
Start Date
December 1 2023
End Date
July 31 2024
Last Update
August 2 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Care Specialists of Illinois
Decatur, Illinois, United States, 62526
2
OptumCare Cancer Care
Las Vegas, Nevada, United States, 89102
3
New Jersey Cancer Care, PA
Belleville, New Jersey, United States, 07042
4
Cayuga Medical Center
Ithaca, New York, United States, 14850