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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05580887
• Other study ID #: Microbiome_BC&PnC
• Status: Recruiting
• Start date: May 12, 2022
• Est. completion date: August 2025

Study information

• Verified date: October 2022
• Source: Moscow Clinical Scientific Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: August 2025
• Est. primary completion date: May 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

• autoimmune disease

• active steroid therapy

• ECOG > 2

• any previous therapy for breast cancer

• metastatic cancer

• antibiotic use less than 28 days

• other tumor

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Moscow Clinical Scientific Center named after AS Loginov	Moscow	Not Required

Sponsors (1)

Lead Sponsor	Collaborator
Moscow Clinical Scientific Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	30 months (6 months treatment period+24 months follow up)
Secondary	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.	30 months
Secondary	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	18 months (6 months treatment period+ 12 months follow up)
Secondary	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	18 months (6 months treatment period+ 12 months follow up)