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.

Inclusion Criteria - Registration:

  • Age ≥ 18 years.
  • Histologically confirmed, operable, stage I-III invasive breast cancer.
    • Note: Patients with oligometastatic breast cancer (up to 3 isolated distant metastases) will be eligible if there are plans to proceed with locoregional management (surgery ± radiation) and metastasis-directed therapy (radiation or resection).
  • Recommended to receive neoadjuvant chemotherapy treatment by their primary medical oncologist and planning to receive one of the regimens listed below: Sequential taxane and anthracycline-based:
    • Taxane (paclitaxel, nab-paclitaxel, or docetaxel) +/- carboplatin +/- (pembrolizumab or atezolizumab) +/- trastuzumab +/- pertuzumab followed by doxorubicin (Adriamycin)/cyclophosphamide (Cytoxan) (A/C) Non-anthracycline;
    • TCH +/- P (docetaxel, carboplatin, trastuzumab +/- pertuzumab);
    • TH +/- P (paclitaxel, trastuzumab +/- pertuzumab);
    • TC (docetaxel, cyclophosphamide);
    • Taxane + platinum (docetaxel, paclitaxel, or nab-paclitaxel + carboplatin or cisplatin).
  • 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.
  • Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic.

Exclusion Criteria - Registration:

  • Patients who have initiated neoadjuvant chemotherapy for the current malignancy prior to registration.
  • Inability to provide blood samples based on the judgement of the treating physician.
  • Other active malignancy ≤ 3 years prior to registration.
    • EXCEPTIONS: Non-melanotic skin cancer or non-invasive malignancies (e.g., carcinoma in situ).
    • NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (e.g., chemotherapy, immunotherapy, or other biologic/targeted therapy including hormonal therapy).
  • Psychiatric illness/social situations (including drug addiction) that would limit compliance with study requirements.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with protocol requirements.
  • Patient is pregnant or breastfeeding or plans to become pregnant.

Eligibility last updated 8/25/21. Questions regarding updates should be directed to the study team contact.

 

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.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions