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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI Biopsy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring MRI, Biopsy, 17-390

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Westchester (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (All Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI biopsy

Arm Description

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

Outcomes

Primary Outcome Measures

estimate the negative predictive value (NPV) of a percutaneous MRI biopsy
In this context NPV is defined as the number of true negatives (biopsy negative, i.e., no disease found on the percutaneous biopsy and pCR) divided by the number of all biopsy negatives. While NPV is of primary interest we will also estimate positive predictive value, sensitivity, and specificity of the biopsy.

Secondary Outcome Measures

Full Information

First Posted
September 19, 2017
Last Updated
October 2, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03289195
Brief Title
Evaluate The Accuracy Of Breast MRI Biopsy In Diagnosing A Complete Tumor Response For Some Women Following Neoadjuvant Chemotherapy For Breast Cancer
Official Title
A Prospective Study To Evaluate The Accuracy Of Percutaneous Breast MRI Biopsy In Diagnosing A Pathologic Complete Response Following Neoadjuvant Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
MRI, Biopsy, 17-390

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This prospective single institution pilot study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRI biopsy
Arm Type
Experimental
Arm Description
All patients enrolled will have had complete MR imaging response post Neoadjuvant Chemotherapy (NAC) and will undergo percutaneous MR guided biopsy.
Intervention Type
Procedure
Intervention Name(s)
MRI Biopsy
Intervention Description
Patient will undergo percutaneous MR guided biopsy by study Breast Radiologist within 0-60 days of completing NAC.
Primary Outcome Measure Information:
Title
estimate the negative predictive value (NPV) of a percutaneous MRI biopsy
Description
In this context NPV is defined as the number of true negatives (biopsy negative, i.e., no disease found on the percutaneous biopsy and pCR) divided by the number of all biopsy negatives. While NPV is of primary interest we will also estimate positive predictive value, sensitivity, and specificity of the biopsy.
Time Frame
2 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Breast Cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Sutton, MD
Phone
646-888-5455
Email
suttone@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud El-Tamer, MD
Phone
646-888-4755
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Sutton, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Sutton, MD
Phone
646-888-5455
Facility Name
Memorial Sloan Kettering Monmouth (All Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Sutton, MD
Phone
646-888-5455
Facility Name
Memorial Sloan Kettering Bergen (All Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Sutton, PhD
Phone
646-888-5455
Facility Name
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Sutton, MD
Phone
646-888-5455
Facility Name
Memorial Sloan Kettering Westchester (All Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Sutton, MD
Phone
646-888-5455
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Sutton, MD
Phone
646-888-5455
First Name & Middle Initial & Last Name & Degree
Mahmoud El-Tamer
Phone
646-888-4755
Facility Name
Memorial Sloan Kettering Nassau (All Protocol Activities)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Sutton, MD
Phone
646-888-5455

12. IPD Sharing Statement

Citations:
PubMed Identifier
33449096
Citation
Sutton EJ, Braunstein LZ, El-Tamer MB, Brogi E, Hughes M, Bryce Y, Gluskin JS, Powell S, Woosley A, Tadros A, Sevilimedu V, Martinez DF, Toni L, Smelianskaia O, Nyman CG, Razavi P, Norton L, Fung MM, Sedorovich JD, Sacchini V, Morris EA. Accuracy of Magnetic Resonance Imaging-Guided Biopsy to Verify Breast Cancer Pathologic Complete Response After Neoadjuvant Chemotherapy: A Nonrandomized Controlled Trial. JAMA Netw Open. 2021 Jan 4;4(1):e2034045. doi: 10.1001/jamanetworkopen.2020.34045.
Results Reference
derived
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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