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

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
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Record History

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  1. Primary and study completion pushed from Sep 2026 to Sep 2027
    • Eligibility criteria expanded, about 15 words
    • Publications: details revised at 1 of 1 entry
  2. Primary and study completion dates: Sep 2025 to Sep 2026v19
  3. Re-verified, no change to tracked fieldsv18
  4. Primary and study completion dates: Sep 2024 to Sep 2025v17
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 45 to confirmed 31
    • Site details revised at 7 of 7 sites
    v16
Show 14 earlier versionsHide 14 earlier versions
  1. Primary and study completion dates: Sep 2023 to Sep 2024v15
  2. Re-verified, no change to tracked fieldsv14
  3. Primary and study completion dates: Sep 2022 to Sep 2023
    • Study sites: 6 to 7
    v13
  4. Study sites revised (6)v12
  5. Study sites revised (6)v11
  6. Primary and study completion dates: Sep 2021 to Sep 2022
    • Eligibility criteria expanded, about 10 words
    v10
  7. Enrollment target: 25 to 45v9
  8. Primary and study completion dates: Sep 2020 to Sep 2021v8
  9. Eligibility criteria expanded, about 3 wordsv7
  10. Primary and study completion dates: Sep 2019 to Sep 2020
    • Enrollment target: 20 to 25
    • Study sites: 1 to 6
    v6
  11. Re-verified, no change to tracked fieldsv5
  12. Eligibility criteria expanded, about 3 wordsv4
  13. 2 versions Re-verified since Jan 17, 2018, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03289195
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov