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 |
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.
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.
We found this trial at
6
sites
480 Red Hill Road
Middletown, New Jersey 07748
Middletown, New Jersey 07748
Phone: 646-888-5455
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
Basking Ridge, New Jersey 07920
Phone: 646-888-5455
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650 Commack Road
Commack, New York 11725
Commack, New York 11725
Phone: 646-888-5455
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500 Westchester Avenue
Harrison, New York 10604
Harrison, New York 10604
Phone: 646-888-5455
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225 Summit Avenue
Montvale, New Jersey 07645
Montvale, New Jersey 07645
Phone: 646-888-5455
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Phone: 646-888-5455
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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