Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer

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.

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Key information

Conditions

TN ER-/PR-/HER2- Breast Cancer Breast Diseases Breast Neoplasms ERany/PRany/HER2+ Breast Cancer HER2-positive Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Cancer Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Trimodality Breast Imaging

Radiation

Standard breast imaging with or without core needle biopsy after neoadjuvant chemotherapy (NAC).

Primary outcomes

Complete Pathologic Response (pCR)

Time frame: 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 outcomes

Complications and Side Effects of the Needle Biopsy Procedure after NAC

Time frame: 6 Months Post Surgery

Incidence of Adverse Events

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2024
First posted: Jun 11, 2019
Registry last updated: Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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