Clinical trial NCT04897009: Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Operable Breast Cancer
Official title: Evaluating the Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Patients With Operable Breast Cancer (ENHANCE)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Invasive Breast Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-05-21
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed, operable, invasive breast cancer

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.

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

Primary outcomes:
measure: Association of peripheral blood immune phenotypes with pathological complete response
timeFrame: Up to 5 years
measure: Difference of peripheral blood immune phenotypes
timeFrame: Up to 5 years
Secondary outcomes:
measure: Changes in baseline peripheral blood immune phenotype as a consequence of neoadjuvant chemotherapy (NAC)
timeFrame: Baseline up to 2-4 weeks post-surgery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Roberto A. Leon-Ferre, M.D.
role: PRINCIPAL_INVESTIGATOR
References: