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

Launched by DANISH BREAST CANCER COOPERATIVE GROUP · Sep 3, 2024

Keywords

ClinConnect Summary

This clinical trial, called DBCG R25, is studying a new treatment called trastuzumab-deruxtecan to see how well it works compared to standard therapy for women with a specific type of metastatic breast cancer. The focus is on women who have ER-positive (which means their cancer cells have certain hormone receptors) and HER2-low breast cancer that has spread beyond its original site. The goal is to find out if this new medication can help patients live longer without their cancer getting worse.

To be eligible for this trial, women need to be at least 18 years old and have been diagnosed with metastatic breast cancer that meets certain criteria, including having a specific type of hormone receptor status. Participants will be closely monitored throughout the study, and they will receive either the new treatment or the standard of care. It's important to note that the trial is not yet recruiting participants, so it may take some time before enrollment begins. If you or someone you know is interested, it’s a good idea to discuss it with a healthcare provider to see if it’s a suitable option.

Gender

FEMALE

Eligibility criteria

• 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)