We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Operable Breast Cancer, the ENHANCE Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04897009
Recruitment Status : Recruiting
First Posted : May 21, 2021
Last Update Posted : September 30, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment
Invasive Breast Carcinoma Procedure: Biospecimen Collection

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 165 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluating the Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Patients With Operable Breast Cancer (ENHANCE)
Actual Study Start Date : June 9, 2021
Estimated Primary Completion Date : May 15, 2024
Estimated Study Completion Date : May 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.
Procedure: Biospecimen Collection
Undergo blood and tissue collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood, tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with histologically confirmed, operable, invasive breast cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04897009


Locations
Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Roberto A. Leon-Ferre, M.D.         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Roberto A Leon-Ferre Mayo Clinic in Rochester
Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT04897009    
Other Study ID Numbers: MC200302
NCI-2021-04162 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC200302 ( Other Identifier: Mayo Clinic in Rochester )
P30CA015083 ( U.S. NIH Grant/Contract )
P50CA116201 ( U.S. NIH Grant/Contract )
First Posted: May 21, 2021    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases