Breast CancerNCT06126003
Gut and Tumor Microbiome in Patients With Early Stage (II-III), Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer.
An observational study of Breast Cancer, run by BioCorteX Inc at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Observation
- How many people
- 2 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Dec 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
New Jersey Cancer Care, PA
Belleville, New Jersey, 07042
Cancer Care Specialists of Illinois
Decatur, Illinois, 62526
Valley Cancer Associates, PA
Harlingen, Texas, 78550
Cayuga Medical Center
Ithaca, New York, 14850
OptumCare Cancer Care
Las Vegas, Nevada, 89102
Toledo Clinic Cancer Center
Toledo, Ohio, 43623
About this study
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).
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Observation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening, week 2, week 4, week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Dec 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Why it stopped: Did not reach enrollment goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCorteX Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tempus AI
- Responsible party
- Sponsor
- Investigators
- Nik Sharma, PhD, Study director, BioCorteX Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126003
- Sponsor's protocol ID
- BIOMAP-201
- Status last verified
- Jul 2024
- First submitted
- 6 Nov 2023
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT06126003
- Acronym / sponsor ID
- BIOMAP-201
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Did not reach enrollment goals
- Enrolment
- 2 participants (actual)
- Lead sponsor
- BioCorteX IncIndustry (pharma, biotech, devices)
- Collaborators
- Tempus AI
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Advanced ER-positive and HER2-negative Breast Cancer | – | Other: ObservationAdvanced ER+ and HER2- breast cancer participants due to receive standard of care CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) in combination with endocrine therapy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationNo Intervention | Other | Arm 1: Advanced ER-positive and HER2-negative Breast Cancer |
Primary outcome
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.
Time frame: Screening, week 2, week 4, week 6
Microbiome data obtained from fecal samples will be compared using alpha and beta diversity metrics.
Results and safety
The study was stopped early (reason given: Did not reach enrollment goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nik Sharma, PhD study director
BioCorteX Inc
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by BioCorteX Inc at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Did not reach enrollment goals). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Screening, week 2, week 4, week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.