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
Trial Information
Current as of July 09, 2025
Not yet recruiting
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)
About Danish Breast Cancer Cooperative Group
The Danish Breast Cancer Cooperative Group (DBCG) is a prominent clinical trial sponsor dedicated to advancing the prevention, diagnosis, and treatment of breast cancer. Established in Denmark, DBCG conducts rigorous, multi-center clinical trials that emphasize collaboration among healthcare professionals, researchers, and institutions. With a focus on evidence-based practices, the group aims to improve patient outcomes through innovative research and the implementation of clinical guidelines. By fostering a comprehensive network of expertise and resources, DBCG plays a vital role in enhancing the understanding of breast cancer and optimizing treatment strategies for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported