Clinical trial · Observational
Intestinal Microbiota Impact for Prognosis and Treatment Outcomes in Early Luminal Breast Cancer and Pancreatic Cancer Patients
NCT05580887CI-TRIAL-00061450unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The gut microbiota (GM) can influence as effectiveness of immunotherapy as prognosis factor in cancer patients. The goal of the study to identify GM pattern is associated with poor and favourable treatment outcomes in breast cancer and pancreatic cancer patients for further treatment strategy proper planning.
Conditions
Conditions (2)
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 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cyclophosphamid | Drug | — | UNRESOLVED |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| mFOLFIRINOX | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- Patients with luminal A breast cancer
- label
- Patients with high risk luminal B breast cancer
- interventionNames
- Drug: Doxorubicin
- Drug: Cyclophosphamid
- Drug: Paclitaxel
- Drug: Carboplatin
- label
- Patients with high pancreatic cancer
- interventionNames
- Drug: mFOLFIRINOX
Primary outcomes (1)
- measure
- Intestinal bacterial structure in BC and PnC (separately) patients with disease progression
- timeFrame
- 24 months
- description
- Intestinal bacterial structure will performed by 16S RNA gene sequencing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.