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

Last updated: October 12, 2022
Sponsor: Moscow Clinical Scientific Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatic Cancer

Breast Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT05580887
Microbiome_BC&PnC
  • Ages 18-80
  • All Genders

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.

Eligibility Criteria

Inclusion

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 21days 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

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

Study Design

Total Participants: 35
Study Start date:
May 12, 2022
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Moscow Clinical Scientific Center named after AS Loginov

    Moscow, Not Required Moscow
    Russian Federation

    Active - Recruiting

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