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

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03289195
• Collaborator: (none)
• Enrollment: 45
• Locations: 7
• Arm: 1
• Anticipated Duration (Months): 71.4
• Patients Per Site: 6.4
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Procedure: MRI Biopsy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This prospective single institution pilot study.This prospective single institution pilot study.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Prospective Study To Evaluate The Accuracy Of Percutaneous Breast MRI Biopsy In Diagnosing A Pathologic Complete Response Following Neoadjuvant Chemotherapy
• Actual Study Start Date: Sep 18, 2017
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MRI biopsy All patients enrolled will have had complete MR imaging response post Neoadjuvant Chemotherapy (NAC) and will undergo percutaneous MR guided biopsy.	Procedure: MRI Biopsy; Patient will undergo percutaneous MR guided biopsy by study Breast Radiologist within 0-60 days of completing NAC.

Outcome Measures

Primary Outcome Measures

1. estimate the negative predictive value (NPV) of a percutaneous MRI biopsy [2 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Basking Ridge (All Protocol Activities)	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (All Protocol Activities)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (All Protocol Activities)	Rockville Centre	New York	United States	11570

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Elizabeth Sutton, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT03289195
• Other Study ID Numbers: 17-390
• First Posted: Sep 20, 2017
• Last Update Posted: Nov 24, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Memorial Sloan Kettering Cancer Center: MRI; Biopsy; 17-390
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Nov 24, 2021