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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:September 18, 2017
End Date:September 2020
Contact:Elizabeth Sutton, MD
Email:suttone@mskcc.org
Phone:646-888-5455

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A Prospective Study To Evaluate The Accuracy Of Percutaneous Breast MRI Biopsy In Diagnosing A Pathologic Complete Response Following Neoadjuvant Chemotherapy

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.


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

- 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.
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
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Middletown, New Jersey 07748
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225 Summit Avenue
Montvale, New Jersey 07645
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1275 York Ave
New York, New York 10021
(212) 639-2000
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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