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

NCT04897009 | Active Not Recruiting

• 4 other identifiers: MC200302NCI-2021-04162P50CA11620120-010563
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• Association of peripheral blood immune phenotypes with pathological complete response

  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

  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.

  Up to 5 years

Secondary Outcomes (1)

• Changes in baseline peripheral blood immune phenotype as a consequence of neoadjuvant chemotherapy (NAC)

  Baseline up to 2-4 weeks post-surgery

Study Arms (1)

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

Interventions

Biospecimen Collection PROCEDURE

Undergo blood and tissue collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Basic science (biospecimen collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically confirmed, operable, invasive breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Roberto A. Leon-Ferre, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: June 9, 2021
• Primary Completion (Estimated): June 8, 2028
• Study Completion (Estimated): June 8, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)