Clinical trial · Observational
Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Operable Breast Cancer
Evaluating the Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Patients With Operable Breast Cancer (ENHANCE)
- 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 early phase I trial evaluates the impact of chemotherapy before surgery (neoadjuvant) on the peripheral blood immune phenotype in patients with operable breast cancer. Collecting blood and information from patients with breast cancer may help to understand how the immune system influences response to treatment, and how the immune system reacts to breast cancer treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Basic science (biospecimen collection)
- description
- Patients undergo blood sample collection at baseline (prior to first NAC treatment), after taxane and prior to first dose of A/C (for patients receiving a taxane), end of NAC, 1-4 weeks and 6 months post-surgery. Patients also undergo tissue collection at 1-4 weeks and 6 months post-surgery.
- interventionNames
- Procedure: Biospecimen Collection
Primary outcomes (2)
- measure
- Association of peripheral blood immune phenotypes with pathological complete response
- timeFrame
- Up to 5 years
- description
- For each of the ten unique family subtypes, and individual cell population within a histological subtype, will utilize a logistic regression model to identify those markers measured at baseline that are predictive of achieving a pathological complete response. Will also perform classification and regression trees (CART) modeling to get at the interplay of the markers (i.e. cell subtypes), which are all uniformly expressed as percentages.
- measure
- Difference of peripheral blood immune phenotypes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 years * Histologically confirmed, operable, invasive breast cancer. Note: Patients with oligometastatic breast cancer (up to 3 isolated distant metastases) will be eligible after review and approval by principal investigator (PI) * Recommended to receive neoadjuvant systemic treatment by their primary medical oncologist and planning to receive one of the regimens * Provide written informed consent * Willing to return to Mayo Clinic for breast cancer surgery * Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic Exclusion Criteria: * Patients who have already initiated neoadjuvant chemotherapy for the current malignancy * Inability to provide blood samples based on the judgement of the treating physician * Inability to comply with the protocol * Patient is pregnant or plans to become pregnant
References
Publications (0)
Data not yet available