Last reviewed · How we verify
NCT06318507: IMPACT
The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
trial testing Fecal microbial diversity in Breast Neoplasms in 25 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Pennington Biomedical Research Center |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 25 |
| Start date | 11 March 2024 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Fecal microbial diversity
Conditions studied
- Breast Neoplasms — all drugs for Breast Neoplasms →
Sponsor
Pennington Biomedical Research Center — full company profile →
Who can join
18 and older, female only, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Gut microbiota interact with breast cancer therapeutics to modulate efficacy.
Arnone AA, Ansley K, Heeke AL, Howard-McNatt M, et al · · 2025 · cited 9× · PMID 39820166 · DOI 10.1038/s44321-024-00185-0 -
Nutritional status, immunonutrition, and gut microbiome: a coming of age for immunotherapy?
Mattavelli E, Agustoni F, Tartara A, De Simeis F, et al · · 2025 · cited 3× · PMID 40927712 · DOI 10.3389/fimmu.2025.1612567 -
Unlocking the Microbial Symphony: The Interplay of Human Microbiota in Cancer Immunotherapy Response.
Chacon J, Faizuddin F, McKee JC, Sheikh A, et al · · 2025 · cited 3× · PMID 40075661 · DOI 10.3390/cancers17050813
Verify or expand the search:
- PubMed search for NCT06318507
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Pennington Biomedical Research Center trials
Trials by the same sponsor.
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- NCT07305753 — CanCan Body Composition Study · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06318507 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pennington Biomedical Research Center
- Last refreshed: 17 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06318507.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing