Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer

  • End date
    Jan 20, 2025
  • participants needed
  • sponsor
    Masonic Cancer Center, University of Minnesota
Updated on 15 February 2022
breast cancer
carcinoma in situ
invasive breast cancer
ductal carcinoma in situ
ductal carcinoma
core needle biopsy


This is a feasibility study to gain preliminary information regarding whether breast imaging with or without a core needle biopsy after neoadjuvant chemotherapy (NAC) but before surgery can accurately predict complete pathologic response (pCR) in women with triple negative or HER2- positive breast cancer. pCR is defined as having no residual invasive breast cancer or ductal carcinoma in situ.

Condition TN ER-/PR-/HER2- Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer, ERany/PRany/HER2+ Breast Cancer
Treatment Standard Trimodality Breast Imaging
Clinical Study IdentifierNCT03981705
SponsorMasonic Cancer Center, University of Minnesota
Last Modified on15 February 2022


Yes No Not Sure

Inclusion Criteria

Biopsy proven triple negative (TN) (ER-/PR-/HER2-) or HER2 positive (ERany/PRany/HER2+) breast cancer for which neoadjuvant chemotherapy is planned
A biopsy clip placed at the time of diagnostic biopsy
years of age or older
Must be able to read and write in English due to the importance of survey (questionnaire) completion to meet the study's endpoint - this is justified as there is no individual benefit to study participation
Able to provide written consent prior to any research related activities

Exclusion Criteria

Stage IV breast cancer
T4 breast cancer
Previous ipsilateral breast cancer
Any contraindication for undergoing a contrast-enhanced breast MRI and/or the breast biopsy between chemotherapy and surgery
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