Evaluate The Accuracy Of Breast MRI Biopsy In Diagnosing A Complete Tumor Response For Some Women Following 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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-18

Study Completion Date

2026-09-30

Brief Summary

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The purpose of this study is to test the ability of a breast MRI biopsy to accurately diagnose a complete tumor response to the neoadjuvant chemotherapy (NAC) that the patient just finished. Numerous studies have shown that MRI has the highest accuracy for diagnosing a complete tumor response. The investigator wants to see if in a certain group of women who's breast cancer is no longer visible on the post-treatment MRI that the biopsy specimens from a MRI guided biopsy will accurately diagnose a complete tumor response to treatment which may in the future make breast surgery unnecessary in some women.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This prospective single institution pilot study.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI biopsy

All patients enrolled will have had complete MR imaging response post Neoadjuvant Chemotherapy (NAC) and will undergo percutaneous MR guided biopsy.

Group Type EXPERIMENTAL

MRI Biopsy

Intervention Type PROCEDURE

Patient will undergo percutaneous MR guided biopsy by study Breast Radiologist within 0-60 days of completing NAC.

Interventions

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MRI Biopsy

Patient will undergo percutaneous MR guided biopsy by study Breast Radiologist within 0-60 days of completing NAC.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women age 18 years or older
* Confirmed histologic diagnosis of operable HER2 overexpressing (ER\<10%, PR\<10%, and HER2 2+ or FISH amplified) OR triple negative (ER\<10%, PR\<10%, and HER2 0/1+ or 2+/FISH not amplified) OR ER positive invasive ductal or invasive lobular breast cancer including MSKCC pathology confirmation
* Operable breast cancer treated with NAC undergoing either breast conservation or total Mastectomy who have had a post-NAC clinical bilateral breast MRI demonstrating a complete imaging response, which is defined as no residual tumor enhancement.
* No indication of distant metastases (M0)
* Tumor site amenable to MRI guided biopsy as determined by the radiologist
* Definitive surgery being performed at MSKCC within within 0-60 days of completing NAC
* ECOG performance status score of 0 to ≤ 2 and or KPS performance status score of 80% to 100%
* Women of childbearing potential (WOCBP) must not be pregnant.
* Women must not be breastfeeding
* Willing and able to provide informed consent and adhere to the study visit schedule and plan as specified in this protocol

Exclusion Criteria

* Medical history and concurrent disease:

* Prior history of treated breast cancer
* Any underlying medical or psychiatric conditions, which in the opinion of the investigator, will make performing the study intervention hazardous or obscure the interpretation of the results
* Prohibited Treatments and/or Therapies:

* Prior history of breast cancer surgery and/or radiotherapy.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No