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

NCT06585969 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: DBCG-R25-DISCORDANT
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Metastatic Breast Cancer; ER-positive Breast Cancer; Luminal B; Her2 Enriched; Basal Like

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  Progression-free survival (ITT)

  Up to 4 years after inclusion

Secondary Outcomes (5)

• Overall survival

  Up to 4 years after inclusion

• PFS by subtype

  Up to 4 years after inclusion

• OS by subtype

  Up to 4 years after inclusion

• Quality of life

  During treatment, estimated 18-24 months

• Toxicity

  During treatment, estimated 18-24 months

Study Arms (2)

Trastuzumab-deruxtecan

EXPERIMENTAL

Trastuzumab deruxtecan until progression or intolerable toxicity: 5.4 mg/kg intravenous on day 1 of a 21 days cycle.

Drug: Trastuzumab deruxtecan (T-DXd)

Immunohistochemistry guided treatment (standard)

ACTIVE COMPARATOR

\- 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)

Drug: Ribociclib with ET; Drug: Abemaciclib with ET

Interventions

Abemaciclib with ET DRUG

Abemaciclib with endocrine therapy

Immunohistochemistry guided treatment (standard)

Trastuzumab deruxtecan (T-DXd) DRUG

Trastuzumab deruxtexan every three weeks

Also known as: Enhertu

Trastuzumab-deruxtecan

Ribociclib with ET DRUG

Ribociclib with endocrine therapy

Immunohistochemistry guided treatment (standard)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Danish Breast Cancer Cooperative Group: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trastuzumab deruxtecan; ribociclib; abemaciclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2026
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2024-10