Clinical trial · Observational
Role of the Immune Environment in Response to Therapy in Breast Cancer
NCT05396612CI-TRIAL-00091826recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an observational case-control study of tissues collected from women with ER+HER2- breast cancers. The immune environments of these cancers will be compared to triple negative and HER2+ breast cancers. No randomization or changes to standard of care treatment will occur as part of the study.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| ER Positive Breast Cancer | — | UNRESOLVED | — |
| HER2-negative Breast Cancer | — | UNRESOLVED | — |
| TNBC - Triple-Negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Collecting, processing and archiving breast cancer tumor tissues
- timeFrame
- Through study completion, average of 2 years
- description
- This study will collect and analyze tumor samples from women diagnosed with primary breast cancer. The investigators will dissociate fresh tumor samples and analyze single cell suspensions by flow cytometry. Percentage of dendritic cell and T cell subsets and dendritic cell and T cell activation markers will be compared between breast cancer subtypes (HR+HER2-, HER2+, triple negative). Percentage of dendritic cell and T cell subsets and dendritic cell and T cell activation markers will be compared between HR+HER2- untreated breast cancers compared to HR+HER2- chemotherapy treated breast cancers.
Secondary outcomes (1)
- measure
- Associating breast cancer dendritic cell infiltrate with outcome
- timeFrame
- 5 years
- description
- We will perform studies to associate dendritic cell infiltration and activation markers with patient outcome, including disease free survival, distant disease free survival, and overall survival.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: Women 18 years of age or older with non-metastatic breast cancer undergoing surgical resection in the University of Pennsylvania Health System. Exclusion criteria: Males Children Pregnant individuals
References
Publications (0)
Data not yet available
No reference posted for this study.