Breast Cancer, Pancreas Cancer
Conditions
Brief summary
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.
Interventions
DRUGmFOLFIRINOX
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.
DRUGDoxorubicin
dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles
DRUGCyclophosphamid
dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles
DRUGPaclitaxel
dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles
DRUGCarboplatin
dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles
Sponsors
Moscow Clinical Scientific Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intestinal bacterial structure in BC and PnC (separately) patients with disease progression | 24 months | Intestinal bacterial structure will performed by 16S RNA gene sequencing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 | 30 months | 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. |
| Change from baseline in intestinal bacterial structure in PnC patients 12 months after after the completion of combined treatment | 18 months (6 months treatment period+ 12 months follow up) | Intestinal bacterial structure will performed by 16S RNA gene sequencing |
| Change from baseline in intestinal bacterial structure in PnC patients with disease relapse on or after combined treatment completion (follow up 12 months) | 18 months (6 months treatment period+ 12 months follow up) | Intestinal bacterial structure will performed by 16S RNA gene sequencing |
Countries
Russia
Outcome results
None listed