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RecruitingNCT05580887Updated Oct 14, 2022

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

An observational study in Breast Cancer and Pancreas Cancer, sponsored by Moscow Clinical Scientific Center. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-14.

Sponsored by Moscow Clinical Scientific Center · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started May 2022; still recruiting 4 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Ages
18 Years to 80 Years
Sex
All
01

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.

02

Conditions studied

  • Breast Cancer
  • Pancreas Cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 35 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Moscow Clinical Scientific Center is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

  • Early lum A and high risk lum B HER2- breast cancer
  • Locally advanced resectable and/or borderline resectable panreatic cancer

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with luminal A breast cancer
  • Patients with high risk luminal B breast cancer

    Drug: Doxorubicin · Drug: Cyclophosphamid · Drug: Paclitaxel · Drug: Carboplatin

  • Patients with high pancreatic cancer

    Drug: mFOLFIRINOX

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

06

What researchers measure

Primary outcomes

  1. Intestinal bacterial structure in BC and PnC (separately) patients with disease progression

    Intestinal bacterial structure will performed by 16S RNA gene sequencing

    Time frame: 24 months

Secondary outcomes

  1. 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

    Time frame: 30 months (6 months treatment period+24 months follow up)

  2. 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.

    Time frame: 30 months

  3. 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

    Time frame: 18 months (6 months treatment period+ 12 months follow up)

  4. 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

    Time frame: 18 months (6 months treatment period+ 12 months follow up)

07

Study locations

1 of 1 sites recruiting
  • Moscow Clinical Scientific Center named after AS Loginov
    Moscow, Not Required Moscow, Russian Federation
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05580887
Lead sponsor
Moscow Clinical Scientific Center
Responsible party
Sponsor
First posted
Oct 14, 2022
Start date
May 12, 2022
Primary completion
May 12, 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
Oct 14, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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