Clinical trial · Observational
Comparison of the Breast Tumor Microenvironment
Differential Comparison of the Breast Tumor Microenvironment Between Luminal A and Triple Negative Breast Cancer With and Without Radiation Treatment
- 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)
The goal of the project is to identify a molecular signature of tumor stroma from "normal" adjacent breast tissue obtained prospectively at the time of breast conserving surgery before and after receiving intraoperative radiation therapy (IORT) in subjects that have luminal A and triple negative breast cancer. IORT is considered as being standard of care.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Receptor Positive Malignant Neoplasm of Breast | — | UNRESOLVED | — |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample collection | Other | — | UNRESOLVED |
| Breast tissue collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Luminal A Breast Cancer
- description
- Luminal A Breast cancer subjects will have tissue specimens and blood collected before and after IORT during the Breast conserving surgery.
- interventionNames
- Other: Breast tissue collection
- Other: Blood sample collection
- label
- Triple Negative Breast Cancer
- description
- Triple Negative breast cancer subjects will have tissue specimens and blood collected before and after IORT during the Breast conserving surgery.
- interventionNames
- Other: Breast tissue collection
- Other: Blood sample collection
Primary outcomes (1)
- measure
- Number of subjects with significant mean percent change in Tumor Infiltrating Lymphocytes (TILs)
- timeFrame
- Two weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Female, age greater than or equal to 40 * Core biopsy proven invasive breast carcinoma or ductal carcinoma in situ (DCIS), all subtypes excluding invasive lobular carcinoma due to increased risk for multifocal disease * Human epidermal growth factor receptor 2 (HER2) negative regardless of hormone receptor status * Clinically less than or equal to 3cm unifocal lesion * Clinically node negative * Must have diagnostic mammogram performed within last 6 months * Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to 1 * Appropriate renal, liver, and hematologic lab values * Ability to give informed consent Exclusion Criteria: * Multifocal disease * Clinically N1 disease at diagnosis * Invasive lobular carcinoma * Metastatic disease * Patients for whom RT would be contraindicated (e.g., connective tissue disorder or prior ipsilateral breast radiation) * Patients with known BRCA1/2 mutations * Pregnant or nursing
References
Publications (0)
Data not yet available