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

Sponsor
Danish Breast Cancer Cooperative Group
Study ID
NCT06585969
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab deruxtecan (T-DXd) — DRUG
    Trastuzumab deruxtexan every three weeks
  • Ribociclib with ET — DRUG
    Ribociclib with endocrine therapy
  • Abemaciclib with ET — DRUG
    Abemaciclib with endocrine therapy

Study Details

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

Key Dates

Start date
Jan 1, 2026
Status verified
Oct 2024
Primary completion
Jan 1, 2026
Completion
Jan 1, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Trastuzumab-deruxtecan
    Trastuzumab deruxtecan until progression or intolerable toxicity: 5.4 mg/kg intravenous on day 1 of a 21 days cycle.
  • Active Comparator: Immunohistochemistry guided treatment (standard)
    \- CDK4/6 inhibitor with an endocrine therapy until progression og intolerable toxicity * CDK4/6 inhibitor: Physician's choice of ribociclib (600mg daily for 21 days in a 4 week schedule) or abemaciclib (125mg twice daily). * Endocrine therapy: letrozole (2.5mg daily), anastrozole (1mg daily), exemestane (25mg daily), tamoxifen (20mg daily) or fulvestrant (intramuscular 500mg every 4 weeks)

Primary Outcome Measure

Primary outcome [ Time Frame: Up to 4 years after inclusion ]

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