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Safe De-escalation of Chemotherapy for Stage 1 Breast Cancer

Study acronym: Safe-De
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 22, 2023 (before its estimated December 5, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: May 1, 2023 to Dec 5, 2025
    • Start date changed from estimate of Nov 1, 2021 to Jun 5, 2023
    • Study sites: 1 to 2
    • Study completion date: Nov 1, 2027 to Dec 5, 2028
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 aim of this study is to assess the rates of circulating tumour DNA (ctDNA) in patients treated with surgery for stage 1 breast cancer that is HER2 positive or triple negative. The study will involve collecting blood samples from patients before and after surgery, if patients are enrolled after surgery, blood samples will be collected after the procedure. On the follow-up visit, the results obtained from the blood tests will serve as a diagnostic method to discern adverse outcomes in the groups of patients with positive and negative ctDNA detection. Also, the results obtained will aid physicians in determining treatment courses for patients, in order to reduce the intensity of adjuvant chemotherapy. By identifying the patients with residual disease with ctDNA analysis, it is possible that this will improve disease prognosis.
Trial Details
NCT Number NCT05058183
Lead Sponsor Royal Marsden NHS Foundation Trust
Collaborators: Massachusetts General Hospital, Natera, Inc.
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov