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Withdrawn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

First listed
Sep 19, 2024
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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