Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer

Completed

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

• Registration Number: NCT03981705
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-11
• Study Start: 2019-08-08
• Primary Completion: 2024-02-19
• Study Completion: 2024-11-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete Pathologic Response (pCR)	6 Months Post Surgery	The primary aim of this feasibility study is to determine whether breast imaging with or without core needle biopsy after neoadjuvant chemotherapy (NAC) can accurately predict complete pathologic response (pCR) in women with biopsyproven triple negative or HER2+ breast cancer.

Secondary Outcome Measures

Name	Time	Method
Complications and Side Effects of the Needle Biopsy Procedure after NAC	6 Months Post Surgery	Incidence of Adverse Events

Trial Locations

Locations (1)

University of Minnesota Masonic Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States