Intestinal Microbiota Impact for Prognosis and Treatment Outcomes in Early Luminal Breast Cancer and Pancreatic Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Intestinal Microbiota Impact for Prognosis and Treatment Outcomes in Early Luminal Breast Cancer and Pancreatic Cancer Patients

Conditions
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Breast Cancer, Pancreas Cancer

Intervention / Treatment
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* Drug: mFOLFIRINOX
* Drug: Doxorubicin
* Drug: Cyclophosphamid
* Drug: Paclitaxel
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: untreated early HR+ HER2- BC: 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 TanyN1-3M0 Ki67>40% G3 ECOG 0-1 untreated early HR+ HER2- BC: TanyN0M0 Ki67<20% G1 ECOG 0-1 planned induction endocrine therapy (letrozole/anastrazole/tamoxifen) untreated locally-advanced and/or borderline resectable pancreas cancer: planned (neo)adjuvant chemotherapy: mFOLFIRINOX previous surgery ( only R0 resection) is allowed ECOG 0-1 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with luminal A breast cancer<br> | |
| Patients with high risk luminal B breast cancer<br> | Drug: Doxorubicin<br>* dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles<br>Drug: Cyclophosphamid<br>* dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles<br>Drug: Paclitaxel<br>* dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles<br>Drug: Carboplatin<br>* dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles<br>|
| Patients with high pancreatic cancer<br> | Drug: mFOLFIRINOX<br>* every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1 Irinotecan 150 mg/m2 IV over 90 minutes on Day 1 Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal bacterial structure in BC and PnC (separately) patients with disease progression | Intestinal bacterial structure will performed by 16S RNA gene sequencing | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of ctDNA level in the each type of breast cancer patients from diagnosis till 24 months after completion neoadjuvant chemotherapy followed by surgery | Change from baseline of ctDNA level in the each type of breast cancer patients from diagnosis till 24 months after completion neoadjuvant chemotherapy followed by surgery | 30 months (6 months treatment period+24 months follow up) | 
| Change from baseline in intestinal bacterial structure in patients with early high risk luminal breast cancer of recurrence and increasing ctDNA level who are receiving neo/adjuvant chemotherapy regimens | Change from baseline in intestinal bacterial structure in patients with early high risk luminal breast cancer of recurrence and increasing ctDNA level who are receiving neo/adjuvant chemotherapy regimens. Intestinal bacterial structure will performed by 16S RNA gene sequencing. | 30 months | 
| Change from baseline in intestinal bacterial structure in PnC patients 12 months after after the completion of combined treatment | Intestinal bacterial structure will performed by 16S RNA gene sequencing | 18 months (6 months treatment period+ 12 months follow up) | 
| Change from baseline in intestinal bacterial structure in PnC patients with disease relapse on or after combined treatment completion (follow up 12 months) | Intestinal bacterial structure will performed by 16S RNA gene sequencing | 18 months (6 months treatment period+ 12 months follow up) |