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

Running, not enrolling · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03289195

Run by

Memorial Sloan Kettering Cancer Center

People needed

31

Starts

2017-09-18

Expected to finish

2026-09-01

Last updated by the study team

2025-10-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States
• Memorial Sloan Kettering Nassau (All Protocol Activities) — Rockville Centre, New York, United States
• Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities) — Commack, New York, United States

Full record on ClinicalTrials.gov

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