Engineering Gut Microbiome to Target Cancer-Immune Microenvironment in Breast and Lung Cancer

MC210302

This clinical trial evaluates whether engineering gut microbiome using probiotics will alter the body's immune system to react to stage I-III breast or lung cancers that can be removed by surgery (operable). Having diverse species of bacteria inside the bowel may help improve the immune system, particularly the ability of the immune system to recognize cancer. Taking probiotics may change the diversity and make up of the bacteria in the bowels, and change how the immune system reacts to breast or lung cancer.

2021-07-01

2023-03-08

2023-03-08

Completed

Early phase I

6

Inclusion Criteria: * \>= 18 years of age * Histologically confirmed adenocarcinoma of the breast operable stage I-III or histologically confirmed carcinoma of the lung operable stage I-III will be enrolled prior to their definitive surgery * Patients must have adequate organ function * Patients must be willing to provide tissue, blood and stool samples for the research study Exclusion Criteria: * Patients must not receive systemic neoadjuvant therapy * Patients must not have taken any probiotics in the past 30 days prior to the enrollment * Patients with autoimmune disease, immune deficiency such as human immunodeficiency virus (HIV), irritable bowel, known diverticulosis, and other serious gastrointestinal (GI) conditions at treating physician's discretion will be excluded

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}

2023-04-21