Clinical trial · Interventional
Gut Microbiome & Gastrointestinal Toxicities as Determinants of Response to Neoadjuvant Chemo for Advanced Breast Cancer
The Gut Microbiome and Gastrointestinal Toxicities as Determinants of the Response to Neoadjuvant Chemotherapies for Advanced Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left institution in 2019. Study was placed on hold at that time and will not be resuming. No data analysis was performed.
Summary
Brief summary (as posted)
The purpose of this research is to test whether bacteria that normally live in the intestines play a role in fighting cancer. It is believed that the development and behavior of these immune cells may be influenced by bacteria and other microorganisms living in the gut. In turn, the activities of these immune cells could work with anti-cancer therapies to make them more, or less, effective.
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 |
|---|---|---|---|
| Blood & Fecal Collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Blood & Fecal Collection
- description
- Subjects receiving neoadjuvant chemotherapy for advanced breast cancer will be asked to complete questionnaires, provide two blood samples, and provide 2 fecal samples while receiving standard of care neoadjuvant chemotherapy
- interventionNames
- Other: Blood & Fecal Collection
Primary outcomes (1)
- measure
- Number of Subjects Who Complete Fecal Collection
- timeFrame
- Through study completion, an average of 18 months
- description
- At least one fecal kit collected
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with invasive breast cancer and prescribed a regimen that includes neo-adjuvant therapy prior to breast surgery. * Able to provide informed consent. Exclusion Criteria: * History of previous malignancy, other than non-melanoma skin cancers * Inability to tolerate phlebotomy * Immunosuppressive therapy for any other condition * Fever or active uncontrolled infection in the last 4 weeks * Inflammatory bowel disease * Surgery of the stomach, small or large intestines, appendectomy, gastric bypass or gastric banding in the past 6 months. * Active autoimmune disease, including, but not limited to, Systemic lupus erythematosus (SLE), Multiple sclerosis (MS), ankylosing spondylitis
References
Publications (0)
Data not yet available