Clinical trial · Observational
Gut and Tumor Microbiome in Patients With Early Stage (II-III), Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer.
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).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Did not reach enrollment goals
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Arm 1: Advanced ER-positive and HER2-negative Breast Cancer
- description
- 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.
- interventionNames
- Other: Observation
Primary outcomes (1)
- 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
- description
- Microbiome data obtained from fecal samples will be compared using alpha and beta diversity metrics.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available