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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI biopsy | Experimental | All patients enrolled will have had complete MR imaging response post Neoadjuvant Chemotherapy (NAC) and will undergo percutaneous MR guided biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI Biopsy | Procedure | Patient will undergo percutaneous MR guided biopsy by study Breast Radiologist within 0-60 days of completing NAC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Medical history and concurrent disease:
Prohibited Treatments and/or Therapies:
Breast Cancer
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Sutton, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) | Basking Ridge | New Jersey | 07920 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33449096 | Derived | 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. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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This prospective single institution pilot study.
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| Memorial Sloan Kettering Monmouth (All Protocol Activities) |
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Bergen (All Protocol Activities) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (All Protocol Activities) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (All Protocol Activities) | Rockville Centre | New York | 11570 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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