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

Mayo Clinic

Status: Active, not recruiting

Conditions: Invasive Breast Carcinoma

Treatments: Procedure: Biospecimen Collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04897009

20-010563 (Other Identifier)

MC200302 (Other Identifier)

P50CA116201 (U.S. NIH Grant/Contract)

NCI-2021-04162 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

38 participants in 1 patient group

Basic science (biospecimen collection)

Description:

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.

Treatment:

Procedure: Biospecimen Collection