18 and older, female only, with Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Identifying Molecular Alterations in Breast Cancer Tissue Tumor Samples Following Short-Term Preoperative Exposure to Darolutamide in Female Patients Wit Early Breast Cancer.Primary· 1 year, 6 months
Androgen Receptor (AR) was assessed on the collected samples.
Androgen Receptor - Up
Group
Value
95% CI
Presurgical Molecular Assessment
7
Androgen Receptor - Unchanged
Group
Value
95% CI
Presurgical Molecular Assessment
12
Androgen Receptor - Down
Group
Value
95% CI
Presurgical Molecular Assessment
15
Number of Participants With Treatment-related Adverse Events (TEAE) as Assessed by CTCAE v4.03Secondary· 1 year, 6 months
The assessment of safety will be performed for all subjects who have taken at least one tablet of darolutamide (defined as the "safety population")
Group
Value
95% CI
Presurgical Molecular Assessment
26
Presurgical Molecular Assessment
10
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year, 6 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate the effect of short-term treatment with darolutamide on breast cancer cells (i.e., how the treatment may change the genes or proteins in breast cancer cells) and to evaluate its safety and the way it is tolerated by subjects.
The intent is to study these changes in order to have a better understanding of the potential use of darolutamide for women with EBC, know which patients are likely or unlikely to respond to this treatment, and determine how darolutamide may be combined with other anti-cancer drugs.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07505797 — ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)
· recruiting
NCT07198724 — ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrin
· Phase 1, PHASE2
· recruiting
NCT07331506 — Validation of the Oncoliq Test for the Early Detection of Breast Cancer.
· recruiting
NCT07120100 — Transcranial Magnetic Stimulation for Chemotherapy-Induced Peripheral Neuropathy in Breast and Gynecologic Cancer Surviv
· NA
· recruiting
Other Translational Research in Oncology trials
Trials by the same sponsor.
NCT04777851 — Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7
· Phase 3
· terminated
NCT05582031 — Regorafenib With Tislelizumab in Patients With Selected Mismatch Repair-Proficient/Microsatellite Stable Cancers
· Phase 2
· withdrawn
NCT04261218 — Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of Tomivosertib Combined With Paclitaxel in Advanced Breast Can
· Phase 1
· completed
NCT02900560 — Study of Pembrolizumab With or Without CC-486 in Patients With Platinum-resistant Ovarian Cancer
· Phase 2
· terminated
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 Translational Research in Oncology
Last refreshed: 3 April 2020
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/NCT03004534.