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Trial Title:
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
NCT ID:
NCT06585969
Condition:
Metastatic Breast Cancer
ER-positive Breast Cancer
Luminal B
Her2 Enriched
Basal Like
Conditions: Official terms:
Breast Neoplasms
Trastuzumab
Trastuzumab deruxtecan
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Trastuzumab deruxtecan (T-DXd)
Description:
Trastuzumab deruxtexan every three weeks
Arm group label:
Trastuzumab-deruxtecan
Other name:
Enhertu
Intervention type:
Drug
Intervention name:
Ribociclib with ET
Description:
Ribociclib with endocrine therapy
Arm group label:
Immunohistochemistry guided treatment (standard)
Intervention type:
Drug
Intervention name:
Abemaciclib with ET
Description:
Abemaciclib with endocrine therapy
Arm group label:
Immunohistochemistry guided treatment (standard)
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
Detailed description:
Study design and setting We will conduct an international, multicentre, open-label,
randomised controlled trial. All oncological departments who treat patients with
metastatic breast cancer can participate. The EU Clinical Trial Regulation will be
applied.
Interventions Trial participants will be randomised to trastuzumab deruxtecan or standard
treatment.
Trastuzumab deruxtecan
Patients randomised to trastuzumab deruxtecan will be treated as:
Trastuzumab deruxtecan until progression or intolerable toxicity, Trastuzumab deruxtecan:
5.4 mg/kg intravenous on day 1 of a 21 days cycle.
Standard
Patients randomised to standard will be treated as:
CDK4/6 inhibitor with an endocrine therapy until progression or intolerable toxicity
CDK4/6 inhibitor: Physician's choice of ribociclib (600mg daily for 21 days in a 28 days
cycle) or abemaciclib (150mg twice daily).
Endocrine therapy: letrozole (2.5mg daily), anastrozole (1mg daily), exemestane (25mg
daily), tamoxifen (20mg daily) or fulvestrant (intramuscular 500mg every 4 weeks)
Other treatment Prophylactic antiemetics are allowed, including corticosteroids.
Prophylactic antibiotics are allowed if deemed necessary for the patient. G-CSF is
allowed when needed.
All other symptomatic treatment to perform best of care is allowed as long as name,
administration and length is documented in the chart. Bone targeted agents are allowed.
No other antineoplastic treatment is allowed.
Radiological evaluation Patients will initially be scanned every 9-12 weeks as per
investigator's or co-investigator's discretion with minimum a CT of the thorax and
abdomen or a FDG-PET/CT. Patients with response can have this interval extended. Upon
progression treatment/control is to be done according to department preferences, but
subsequent treatment and day of death must be registered.
Criteria for 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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
May 1, 2025
Completion date:
May 2029
Lead sponsor:
Agency:
Danish Breast Cancer Cooperative Group
Agency class:
Other
Source:
Danish Breast Cancer Cooperative Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06585969
