Gut and Intratumoral Microbiome Effect on the Neoadjuvant Chemotherapy-induced Immunosurveillance in Triple Negative Breast Cancer
2 other identifiers
observational
49
1 country
3
Brief Summary
The probability of pCR in TNBC patients receiving standard of care neoadjuvant chemotherapy treatment is associated with the dominance of specific intestinal and intratumoral microbiota that promote anti-tumor immunosurveillance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2017
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 27, 2017
CompletedFirst Submitted
Initial submission to the registry
June 11, 2018
CompletedFirst Posted
Study publicly available on registry
July 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2025
CompletedMarch 27, 2026
March 1, 2026
8.1 years
June 11, 2018
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathologic Complete Response
The primary objective of this study is to determine if the probability of pCR (pathologic complete response) in TNBC (triple negative breast cancer) patients treated with standard of care neoadjuvant chemotherapy is correlated with variability in the composition of intestinal and intratumoral microbiota and subsequent short-term alterations in that composition.
completion of chemotherapy, approximately 18 weeks.
Secondary Outcomes (3)
Other Correlations between Pathologic complete Response
completion of chemotherapy, approximately 18 weeks.
Other Correlations between Pathologic complete Response
completion of chemotherapy, approximately 18 weeks.
Other Correlations between Pathologic complete Response
completion of chemotherapy, approximately 18 weeks.
Eligibility Criteria
Newly Diagnosed Triple Negative Breast Cancer Patients
You may qualify if:
- Histologically confirmed new diagnosis of TNBC (\<5% of ER and PR immunoreactivity and HER2- by FISH or IHC staining 0 or 1+)
- \>18 years
- cm mass lesion or greater
- Tumor amenable to percutaneous core biopsy
You may not qualify if:
- chronic anticoagulation therapy
- prior ipsilateral breast surgery, ipsilateral radiotherapy, hormonal therapy or systemic chemotherapy
- Prolonged antibiotic treatment \> 10 days within 1 month of neoadjuvant chemotherapy as prevention or suppression of an ongoing infection
- lactating
- pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hackensack Meridian Healthlead
- Breast Cancer Research Foundationcollaborator
Study Sites (3)
Yale University - Yale Cancer Center
New Haven, Connecticut, 06520-8327, United States
Georgetown University
Washington D.C., District of Columbia, 20057, United States
Hackensack Meridian Health
Hackensack, New Jersey, 07601, United States
Biospecimen
Stool and Blood Specimens
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marson Davidson, MD
Hackensack Meridian Health
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2018
First Posted
July 13, 2018
Study Start
August 27, 2017
Primary Completion
September 15, 2025
Study Completion
September 15, 2025
Last Updated
March 27, 2026
Record last verified: 2026-03