Breast NeoplasmsIMPACTNCT06318507
The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
An observational study of Breast Neoplasms, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Fecal microbial diversity
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of survivors of early triple-negative breast cancer.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Justin Brown, Ph.D., 225-763-2715, justin.brown@pbrc.edu
About this study
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.
- Conditions
- Breast Neoplasms
- Being tested
- Fecal microbial diversity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbial diversityCombination product
Fecal microbiome diversity via 16S rRNA and metagenomic sequencing
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR)
Defined as ypT0/Tis ypN0, ypT0 ypN0, and ypT0/Tis
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start11 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Brown, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318507
- Sponsor's protocol ID
- PBRC 2023-014
- Acronym
- IMPACT
- Status last verified
- Feb 2025
- First submitted
- 11 Mar 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
- ClinicalTrials.gov ID
- NCT06318507
- Acronym / sponsor ID
- IMPACT / PBRC 2023-014
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of survivors of early triple-negative breast cancer.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbial diversityFecal microbiome diversity via 16S rRNA and metagenomic sequencing | Combination product | – |
Primary outcome
Pathologic Complete Response (pCR)
Time frame: Week 24
Defined as ypT0/Tis ypN0, ypT0 ypN0, and ypT0/Tis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin Brown, Ph.D. (225-763-3000, justin.brown@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.