Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-08

Study Completion Date

2024-11-26

Brief Summary

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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

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Conditions

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

Keywords

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Standard Trimodality Breast Imaging

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Todd Tuttle, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, University of Minnesota

Locations

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University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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2018NTLS176

Identifier Type: -

Identifier Source: org_study_id