NCT06318507 · Pennington Biomedical Research Center
The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
(IMPACT)
What this study is about
This study will determine how the intestinal microbiome differs between patients with obesity and early triple-negative breast cancer who achieve a pathologic full disappearance of disease signs from preoperative anti-PD-1 immunotherapy (pembrolizumab) versus patients who do not.
View original scientific description
This study will determine how the intestinal microbiome differs between patients with obesity and early triple-negative breast cancer who achieve a pathologic complete response from preoperative anti-PD-1 immunotherapy (pembrolizumab) versus patients who do not.
Interventions
COMBINATION_PRODUCT
Fecal microbial diversity
Fecal microbiome diversity via 16S rRNA and metagenomic sequencing
Primary outcome measures
Pathologic Complete Response (pCR)
Time frame: Week 24
Defined as ypT0/Tis ypN0, ypT0 ypN0, and ypT0/Tis
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥18 years
- Female biological sex
- Newly diagnosed, previously untreated, histologically confirmed early triple-negative breast cancer
- Plan to initiate preoperative anti-PD-1 immunotherapy using pembrolizumab
- Overweight or obesity, defined as a body mass index \>=25 kg/m2
- Ability to provide written informed consent
- Allow the collection and storage of biospecimens and data for future use
Exclusion criteria
- Active autoimmune disease
- Concomitant conditions that require the use of antibiotics (e.g., chronic sinusitis)
- Digestive disease disorders (e.g., irritable bowel syndrome, Crohn's disease)
- Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks
- Recent (within 90 days) use of glucocorticoids for more than 10 consecutive days
- Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, or other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol
- Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol
Where
- Baton Rouge, Louisiana
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2025 · Source of record for eligibility and locations