- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04897009
Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Operable Breast Cancer (ENHANCE)
Evaluating the Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Patients With Operable Breast Cancer (ENHANCE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate whether pre-neoadjuvant chemotherapy (NAC) peripheral blood immune phenotypes (defined by mass cytometry) are associated with pathologic complete response (pCR) after neoadjuvant chemotherapy in patients with operable breast cancer.
II. To evaluate whether the baseline peripheral blood immune phenotype differs between patients with breast cancer and age-matched healthy controls.
SECONDARY OBJECTIVES:
I. To characterize changes in the baseline peripheral blood immune phenotype that arise as a consequence of neoadjuvant chemotherapy.
II. To create a biorepository of peripheral blood samples for future research in breast cancer, including circulating tumor deoxyribonucleic acid (ctDNA), epigenetic and functional studies.
EXPLORATORY OBJECTIVE:
I. To evaluate differences in peripheral blood immune phenotype of patients with oligometastatic breast cancer compared to patients with stage I-III breast cancer.
OUTLINE:
Patients undergo blood sample collection at baseline (prior to first NAC treatment), after taxane and prior to first dose of anthracycline/cyclophosphamide (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.
After completion of study treatment, patients are followed up every 6 months for up to 5 years.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Basic science (biospecimen collection)
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.
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Undergo blood and tissue collection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association of peripheral blood immune phenotypes with pathological complete response
Time Frame: Up to 5 years
|
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.
|
Up to 5 years
|
Difference of peripheral blood immune phenotypes
Time Frame: Up to 5 years
|
Will be assessed between patients with breast cancer and age-matched healthy controls.
Will compare the average difference in the baseline marker expression between the cases and age-matched healthy controls using a two-sample t-test.
The two-sample t-test will be used to test the null hypothesis of no difference in means against the alternative hypothesis that there is a difference in means; the two-sided P-value will be reported.
Will also perform CART modeling as in the first co-primary objective to get at the interplay of the markers.
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Up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in baseline peripheral blood immune phenotype as a consequence of neoadjuvant chemotherapy (NAC)
Time Frame: Baseline up to 2-4 weeks post-surgery
|
Will calculate the absolute change for each of the 30 markers, including grouped by the ten unique family subsets.
In this largely descriptive analysis, within each histologic subtype, the expression levels will be graphically displayed over time (e.g.
plotting the median at each of the three occasions, as well as plotting the mean change from baseline at post-NAC and post-surgery; the patient-level trajectories will be superimposed.
Because this is a hypothesis generating objective, all data will be graphed and tabulated and any inferential statistics calculated will be limited and should be interpreted with caution.
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Baseline up to 2-4 weeks post-surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Roberto A. Leon-Ferre, M.D., Mayo Clinic in Rochester
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MC200302 (Mayo Clinic in Rochester)
- P30CA015083 (U.S. NIH Grant/Contract)
- NCI-2021-04162 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P50CA116201 (U.S. NIH Grant/Contract)
- 20-010563 (Other Identifier: Mayo Clinic Institutional Review Board)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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