Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer

University of Minnesota (UMN)

Status: Completed

Conditions: ERany/PRany/HER2+ Breast Cancer; TN ER-/PR-/HER2- Breast Cancer; HER2-positive Breast Cancer; Triple Negative Breast Cancer

Treatments: Radiation: Standard Trimodality Breast Imaging

Study type: Observational

Funder types: Other

Identifiers

NCT03981705

2018NTLS176

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 18 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