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

NCT05580887 | Unknown

• 1 other identifier: Microbiome_BC&PnC
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Pancreas Cancer

Outcome Measures

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

  24 months

Secondary Outcomes (4)

• 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 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 PnC patients 12 months after after the completion of combined treatment

  18 months (6 months treatment period+ 12 months follow up)

• 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)

Study Arms (3)

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

mFOLFIRINOX DRUG

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.

Patients with high pancreatic cancer

Doxorubicin DRUG

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 risk luminal B breast cancer

Cyclophosphamid DRUG

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 risk luminal B breast cancer

Paclitaxel DRUG

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 risk luminal B breast cancer

Carboplatin DRUG

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 risk luminal B breast cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• untreated early HR+ HER2- BC:
• 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
• TanyN1-3M0 Ki67\>40% G3
• ECOG 0-1
• untreated early HR+ HER2- BC:
• TanyN0M0 Ki67\<20% G1
• ECOG 0-1
• planned induction endocrine therapy (letrozole/anastrazole/tamoxifen)
• untreated locally-advanced and/or borderline resectable pancreas cancer:
• planned (neo)adjuvant chemotherapy: mFOLFIRINOX
• previous surgery ( only R0 resection) is allowed
• ECOG 0-1
• histology diagnosis verification
• Informed consent
• Eligible blood\&fecal samples and tumor tissue for different time points

You may not qualify if:

• autoimmune disease
• active steroid therapy
• ECOG \> 2
• any previous therapy for breast cancer
• metastatic cancer
• antibiotic use less than 28 days
• other tumor

Sponsors & Collaborators

• Moscow Clinical Scientific Center: lead

Study Sites (1)

Moscow Clinical Scientific Center named after AS Loginov

Moscow, Not Required, Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Pancreatic Neoplasms

Interventions

Doxorubicin; Cyclophosphamide; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Coordination Complexes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: October 14, 2022
• Study Start: May 12, 2022
• Primary Completion: May 12, 2025
• Study Completion: August 1, 2025
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

RU (1)