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

NCT05580887 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2022-10-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

DRUG

Doxorubicin

dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles

DRUG

Cyclophosphamid

dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles

DRUG

Paclitaxel

dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles

DRUG

Carboplatin

dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles

Sponsors & Collaborators

  • Moscow Clinical Scientific Center

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2025-05-12
Completion
2025-08-31

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05580887 on ClinicalTrials.gov