Clinical Trials

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.