Status:
ACTIVE_NOT_RECRUITING
Evaluate The Accuracy Of Breast MRI Biopsy In Diagnosing A Complete Tumor Response For Some Women Following Neoadjuvant Chemotherapy For Breast Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2026
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03289195
Start Date
September 18 2017
End Date
September 1 2026
Last Update
October 10 2025
Active Locations (7)
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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