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Trial Title:
Intestinal Microbiota Impact for Prognosis and Treatment Outcomes in Early Luminal Breast Cancer and Pancreatic Cancer Patients
NCT ID:
NCT05580887
Condition:
Breast Cancer
Pancreas Cancer
Conditions: Official terms:
Breast Neoplasms
Pancreatic Neoplasms
Paclitaxel
Cyclophosphamide
Carboplatin
Doxorubicin
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
mFOLFIRINOX
Description:
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.
Arm group label:
Patients with high pancreatic cancer
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly
PAClitaxel + CARBOplatin every 21 days for 4 cycles
Arm group label:
Patients with high risk luminal B breast cancer
Intervention type:
Drug
Intervention name:
Cyclophosphamid
Description:
dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly
PAClitaxel + CARBOplatin every 21 days for 4 cycles
Arm group label:
Patients with high risk luminal B breast cancer
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly
PAClitaxel + CARBOplatin every 21 days for 4 cycles
Arm group label:
Patients with high risk luminal B breast cancer
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly
PAClitaxel + CARBOplatin every 21 days for 4 cycles
Arm group label:
Patients with high risk luminal B breast cancer
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.
Criteria for eligibility:
Study pop:
- Early lum A and high risk lum B HER2- breast cancer
- Locally advanced resectable and/or borderline resectable panreatic cancer
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Moscow Clinical Scientific Center named after AS Loginov
Address:
City:
Moscow
Zip:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Lyudmila Zhukova
Phone:
84953043035
Email:
lyudmila.zhukova@mail.ru
Start date:
May 12, 2022
Completion date:
August 2025
Lead sponsor:
Agency:
Moscow Clinical Scientific Center
Agency class:
Other
Source:
Moscow Clinical Scientific Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05580887
