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NCT03981705 Clinical Trial

Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer

Triple Negative Breast Cancer Clinical Trial

Official title:
Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03981705
Other study ID # 2018NTLS176
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 8, 2019
Est. completion date January 2025

Study information
Verified date February 2024
Source Masonic Cancer Center, University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 8
Est. completion date January 2025
Est. primary completion date February 19, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Radiation:
• Standard Trimodality Breast Imaging
Standard breast imaging with or without core needle biopsy after neoadjuvant chemotherapy (NAC).

Locations
Country Name City State
United States University of Minnesota Masonic Cancer Center Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complete Pathologic Response (pCR) 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. 6 Months Post Surgery
Secondary Complications and Side Effects of the Needle Biopsy Procedure after NAC Incidence of Adverse Events 6 Months Post Surgery
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