Impact of gut microbiota on treatment outcomes in early breast and pancreatic cancer
Intestinal Microbiota Impact for Prognosis and Treatment Outcomes in Early Luminal Breast Cancer and Pancreatic Cancer Patients
This study is trying to see how the bacteria in the gut affects how well immunotherapy works for people with early breast and pancreatic cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Moscow Clinical Scientific Center Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, doxorubicin, immunotherapy |
| Locations | 1 site (Moscow, Not Required) |
| Trial ID | NCT05580887 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore how gut microbiota influences the effectiveness of immunotherapy and serves as a prognostic factor in patients with early luminal breast cancer and pancreatic cancer. By identifying specific gut microbiota patterns associated with both poor and favorable treatment outcomes, the study seeks to inform better treatment strategies for these patients. Participants will undergo planned chemotherapy regimens while their gut microbiota, blood, fecal samples, and tumor tissues will be analyzed at various time points.
Who should consider this trial
Good fit: Ideal candidates include untreated early HR+ HER2- breast cancer patients and untreated locally-advanced or borderline resectable pancreatic cancer patients who meet specific eligibility criteria.
Not a fit: Patients with autoimmune diseases, metastatic cancer, or those who have received previous therapy for breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies that improve outcomes for patients with early breast and pancreatic cancer.
How similar studies have performed: While the role of gut microbiota in cancer treatment is an emerging field, this specific approach has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * untreated early HR+ HER2- BC: 1. planned neoadjuvant chemotherapy: dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles 2. TanyN1-3M0 Ki67\>40% G3 3. ECOG 0-1 * untreated early HR+ HER2- BC: 1. TanyN0M0 Ki67\<20% G1 2. ECOG 0-1 3. planned induction endocrine therapy (letrozole/anastrazole/tamoxifen) * untreated locally-advanced and/or borderline resectable pancreas cancer: 1. planned (neo)adjuvant chemotherapy: mFOLFIRINOX 2. previous surgery ( only R0 resection) is allowed 3. ECOG 0-1 4. histology diagnosis verification * Informed consent * Eligible blood\&fecal samples and tumor tissue for different time points Exclusion Criteria: * autoimmune disease * active steroid therapy * ECOG \> 2 * any previous therapy for breast cancer * metastatic cancer * antibiotic use less than 28 days * other tumor
Where this trial is running
Moscow, Not Required
- Moscow Clinical Scientific Center named after AS Loginov — Moscow, Not Required, Russian Federation (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.