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

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ClinicalTrials.gov Identifier: NCT04897009
Recruitment Status : Recruiting
First Posted : May 21, 2021
Last Update Posted : January 9, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Tracking Information
First Submitted Date May 18, 2021
First Posted Date May 21, 2021
Last Update Posted Date January 9, 2023
Actual Study Start Date June 9, 2021
Estimated Primary Completion Date May 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 18, 2021)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 18, 2021)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Operable Breast Cancer, the ENHANCE Study
Official Title Evaluating the Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Patients With Operable Breast Cancer (ENHANCE)
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.
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 Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, tissue
Sampling Method Non-Probability Sample
Study Population Patients with histologically confirmed, operable, invasive breast cancer
Condition Invasive Breast Carcinoma
Intervention Procedure: Biospecimen Collection
Undergo blood and tissue collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Study Groups/Cohorts 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.
Intervention: Procedure: Biospecimen Collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 18, 2021)
165
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 15, 2025
Estimated Primary Completion Date May 15, 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04897009
Other Study ID Numbers MC200302
NCI-2021-04162 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P50CA116201 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Mayo Clinic
Original Responsible Party Same as current
Current Study Sponsor Mayo Clinic
Original Study Sponsor Same as current
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Roberto A Leon-Ferre Mayo Clinic in Rochester
PRS Account Mayo Clinic
Verification Date January 2023