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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with luminal A breast cancer | |||
| Patients with high risk luminal B breast cancer |
| ||
| Patients with high pancreatic cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mFOLFIRINOX | Drug | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
untreated early HR+ HER2- BC:
untreated early HR+ HER2- BC:
untreated locally-advanced and/or borderline resectable pancreas cancer:
Informed consent
Eligible blood&fecal samples and tumor tissue for different time points
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow Clinical Scientific Center named after AS Loginov | Recruiting | Moscow | Not Required | Moscow | Russia |
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| Doxorubicin | Drug | dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles |
|
| Cyclophosphamid | Drug | dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles |
|
| Paclitaxel | Drug | dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles |
|
| Carboplatin | Drug | dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles |
|
| 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) |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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