Intestinal Microbiota Impact for Prognosis and Treatment Outcomes in Early Luminal Breast Cancer and Pancreatic Cancer Patients
NCT ID: NCT05580887
Last Updated: 2022-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
35 participants
OBSERVATIONAL
2022-05-12
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with luminal A breast cancer
No interventions assigned to this group
Patients with high risk luminal B breast cancer
Doxorubicin
dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles
Cyclophosphamid
dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles
Paclitaxel
dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles
Carboplatin
dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles
Patients with high pancreatic cancer
mFOLFIRINOX
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.
Interventions
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mFOLFIRINOX
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.
Doxorubicin
dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles
Cyclophosphamid
dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles
Paclitaxel
dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles
Carboplatin
dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles
Eligibility Criteria
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Inclusion Criteria
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
* active steroid therapy
* ECOG \> 2
* any previous therapy for breast cancer
* metastatic cancer
* antibiotic use less than 28 days
* other tumor
18 Years
80 Years
ALL
No
Sponsors
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Moscow Clinical Scientific Center
OTHER
Responsible Party
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Locations
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Moscow Clinical Scientific Center named after AS Loginov
Moscow, Not Required, Russia
Countries
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Facility Contacts
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Other Identifiers
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Microbiome_BC&PnC
Identifier Type: -
Identifier Source: org_study_id
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