Clinical trial NCT05580887: Intestinal Microbiota Impact for Prognosis and Treatment Outcomes in Early Luminal Breast Cancer and Pancreatic Cancer Patients
Official title: Intestinal Microbiota Impact for Prognosis and Treatment Outcomes in Early Luminal Breast Cancer and Pancreatic Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Pancreas Cancer
Lead sponsor: Moscow Clinical Scientific Center
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Intestinal bacterial structure in BC and PnC (separately) patients with disease progression
timeFrame: 24 months
Secondary outcomes:
measure: 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
timeFrame: 30 months (6 months treatment period+24 months follow up)
measure: 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
timeFrame: 30 months
measure: Change from baseline in intestinal bacterial structure in PnC patients 12 months after after the completion of combined treatment
timeFrame: 18 months (6 months treatment period+ 12 months follow up)
measure: Change from baseline in intestinal bacterial structure in PnC patients with disease relapse on or after combined treatment completion (follow up 12 months)
timeFrame: 18 months (6 months treatment period+ 12 months follow up)
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific Center named after AS Loginov
state: Not Required
Study officials:
References: