Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Operable Breast Cancer, the ENHANCE Study
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-010563
NCT ID: NCT04897009
Sponsor Protocol Number: MC200302
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. |
Contact us for the latest status |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available