Clinical Trial

Safe De-escalation of Chemotherapy for Stage 1 Breast Cancer

Study acronym: Safe-De

Recruiting

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.

Summary

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.

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2021-09-17.

Status change: Not Yet Recruiting → Recruiting 2023-06-19

Trial Details

NCT Number	NCT05058183
Lead Sponsor	Royal Marsden NHS Foundation Trust Collaborators: Massachusetts General Hospital, Natera, Inc.
Conditions	Breast Cancer
Enrollment	400 participants
Start Date	2023-06-05
Primary Completion	2025-12-05 (estimated)
Study Completion	2028-12-05 (estimated)
Updated on ClinicalTrials.gov	2023-06-22