WithdrawnPhase 3

A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer

Stopped: Lack of funding

0Started 2026-01-01

Plain-language summary

The objective of this trial, DBCG R25, will be to evaluate the effect of trastuzumab-deruxtecan versus standard of care on progression-free survival (PFS) in first-line for patients with non-Luminal A, ER-positive/HER2-negative metastatic breast cancer

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women aged 18 or above. * Radiologically/pathologically verified metastatic breast cancer. * ER-positive (1% or more) and HER2-low (HER2 1+ or HER2 2+/ISH-neg)10,11. * PAM50 Luminal B, HER2-enriched or Basal-like. * Performance status 0-1. * Evaluable disease Exclusion Criteria: * Patients who are incapable of understanding the written material received * Patients with inaccessible tumour tissue * Other malignant disease within 5 years (in situ cervix and non-melanoma skin cancer excluded)

What they're measuring

Primary outcome

Timeframe: Up to 4 years after inclusion

Trial details

NCT IDNCT06585969

SponsorDanish Breast Cancer Cooperative Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-01

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