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NCT05058183: Safe-De
Safe De-escalation of Chemotherapy for Stage 1 Breast Cancer
NA trial testing ctDNA in Breast Cancer in 400 participants. Currently enrolling.
5 December 2025
Quick facts
| Lead sponsor | Royal Marsden NHS Foundation Trust |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 400 |
| Start date | 5 June 2023 |
| Primary completion | 5 December 2025 |
| Estimated completion | 5 December 2028 |
| Sites | 2 locations across United Kingdom |
Drugs / interventions tested
- ctDNA
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Royal Marsden NHS Foundation Trust
Who can join
18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Future of Breast Cancer Research in the Survivorship Field.
Soldato D, Arecco L, Agostinetto E, Franzoi MA, et al · · 2023 · cited 20× · PMID 37005952 · DOI 10.1007/s40487-023-00225-8 -
Liquid biopsy in triple-negative breast cancer: unlocking the potential of precision oncology.
Mazzeo R, Sears J, Palmero L, Bolzonello S, et al · · 2024 · cited 18× · PMID 39288656 · DOI 10.1016/j.esmoop.2024.103700 -
Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing.
Kobayashi S, Nakamura Y, Hashimoto T, Bando H, et al · · 2025 · cited 6× · PMID 39920551 · DOI 10.1007/s10147-024-02683-0 -
Liquid biopsy in breast cancer: Redefining precision medicine.
Schiavone ML, Scarpitta R, Ravera F, Bleve S, et al · · 2025 · cited 3× · PMID 40740670 · DOI 10.1016/j.jlb.2025.100312 -
Liquid clues: tracking early-stage breast cancer with ctDNA - a mini review.
Easaw S, Hsu J, Steuerwald N, Heeke AL. · · 2025 · cited 1× · PMID 40936717 · DOI 10.3389/fonc.2025.1634859
Verify or expand the search:
- PubMed search for NCT05058183
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ctDNA
Trials testing the same drug.
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- NCT05029869 — Monitoring Minimal Residual Disease in Gastric Cancer by Liquid Biopsy Study Description · active not recruiting
- NCT04022863 — Ovarium Cancer Detection by TEP's and ctDNA · unknown
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
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- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other Royal Marsden NHS Foundation Trust trials
Trials by the same sponsor.
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- NCT06605833 — CARDiac Toxicity Following ImmunOtherapy Treatment for Melanoma · enrolling by invitation
- NCT07008742 — Feasibility Study of Tissue and Blood Collection in Oncogene-addicted and Neoadjuvantly Treated Non Small Cell Lung Canc · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05058183 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Royal Marsden NHS Foundation Trust
- Last refreshed: 22 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05058183.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing