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

• Sponsor: Moscow Clinical Scientific Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05580887
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Anticipated Duration (Months): 38.7
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Pancreas Cancer	Drug: mFOLFIRINOX; Drug: Doxorubicin; Drug: Cyclophosphamid; Drug: Paclitaxel; Drug: Carboplatin

Study Design

• Study Type: Observational
• Anticipated Enrollment: 35 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Intestinal Microbiota Impact for Prognosis and Treatment Outcomes in Early Luminal Breast Cancer and Pancreatic Cancer Patients
• Actual Study Start Date: May 12, 2022
• Anticipated Primary Completion Date: May 12, 2025
• Anticipated Study Completion Date: Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Patients with luminal A breast cancer
Patients with high risk luminal B breast cancer	Drug: Doxorubicin; dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles; Drug: Cyclophosphamid; dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles; Drug: Paclitaxel; dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles; Drug: Carboplatin; 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 pancreatic cancer	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.

Outcome Measures

Primary Outcome Measures

1. 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

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 [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

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 [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.

3. 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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moscow Clinical Scientific Center named after AS Loginov	Moscow	Not Required	Russian Federation	Moscow

Sponsors and Collaborators

• Moscow Clinical Scientific Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Moscow Clinical Scientific Center
• ClinicalTrials.gov Identifier: NCT05580887
• Other Study ID Numbers: Microbiome_BC&PnC
• First Posted: Oct 14, 2022
• Last Update Posted: Oct 14, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Pancreatic Neoplasms; Paclitaxel; Cyclophosphamide; Carboplatin; Doxorubicin

Study Results

No Results Posted as of Oct 14, 2022