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

Recruiting

• Conditions: Pancreas Cancer; Breast Cancer
• Interventions: Drug: mFOLFIRINOX; Drug: Doxorubicin; Drug: Cyclophosphamid; Drug: Paclitaxel; Drug: Carboplatin

• Registration Number: NCT05580887
• Lead Sponsor: Moscow Clinical Scientific Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-12
• Study First Submitted: 2022-06-21
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-12
• Last Update Submitted: 2022-10-12
• Study First Posted: 2022-10-14
• Last Update Posted: 2022-10-14
• Primary Completion: 2025-05-12
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with high risk luminal B breast cancer	Paclitaxel	-
Patients with high pancreatic cancer	mFOLFIRINOX	-
Patients with high risk luminal B breast cancer	Cyclophosphamid	-
Patients with high risk luminal B breast cancer	Carboplatin	-
Patients with high risk luminal B breast cancer	Doxorubicin	-

Primary Outcome Measures

Name	Time	Method
Intestinal bacterial structure in BC and PnC (separately) patients with disease progression	24 months	Intestinal bacterial structure will performed by 16S RNA gene sequencing

Secondary Outcome Measures

Name	Time	Method
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)	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 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	30 months	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.
Change from baseline in intestinal bacterial structure in PnC patients 12 months after after the completion of combined treatment	18 months (6 months treatment period+ 12 months follow up)	Intestinal bacterial structure will performed by 16S RNA gene sequencing
Change from baseline in intestinal bacterial structure in PnC patients with disease relapse on or after combined treatment completion (follow up 12 months)	18 months (6 months treatment period+ 12 months follow up)	Intestinal bacterial structure will performed by 16S RNA gene sequencing

Trial Locations

Locations (1)

Moscow Clinical Scientific Center named after AS Loginov; 🇷🇺 Moscow, Not Required, Russian Federation