Impact Of Neoadjuvant Chemotherapy On The Peripheral Blood Immune Phenotype In Operable Breast Cancer, The ENHANCE Study

Overview

About this study

The purposes of this study are to evaluate whether pre-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, and to evaluate whether the baseline peripheral blood immune phenotype differs between patients with breast cancer and age-matched healthy controls.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

3.1         Registration – Inclusion Criteria

3.11     Age ≥18 years.

3.12     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 PI.

3.13     Recommended to receive neoadjuvant systemic treatment by their primary medical oncologist and planning to receive one of the regimens listed in Section 7.1.

3.14     Provide written informed consent.

3.15     Willing to return to Mayo Clkinic for breast cancer surgery.

3.16     Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic.

3.17     Willingness to provide authorization to access archival tumor tissue specimens for research

3.2       Registration - Exclusion criteria

3.21     Patients who have already initiated neoadjuvant chemotherapy for the current malignancy

3.22     Inability to provide blood samples based on the judgement of the treating physician.

3.23     Inability to comply with the protocol.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Roberto Leon-Ferre, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20513567

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