Status:
ACTIVE_NOT_RECRUITING
Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Operable Breast Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Invasive Breast Carcinoma
Eligibility:
All Genders
18+ years
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 inform...
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) aft...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 8 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04897009
Start Date
June 9 2021
End Date
June 8 2026
Last Update
October 14 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905