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

Moscow Clinical Scientific Center

Status: Enrolling

Conditions: Breast Cancer; Pancreas Cancer

Treatments: Drug: Cyclophosphamid; Drug: Doxorubicin; Drug: mFOLFIRINOX; Drug: Paclitaxel; Drug: Carboplatin

Study type: Observational

Funder types: Other

Identifiers

NCT05580887

Microbiome_BC&PnC

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 3 patient groups

Patients with luminal A breast cancer

Patients with high risk luminal B breast cancer

Treatment:

Drug: Cyclophosphamid

Drug: Paclitaxel

Drug: Carboplatin

Drug: Doxorubicin

Patients with high pancreatic cancer

Treatment:

Drug: mFOLFIRINOX