This study compared two targeted drugs linked to chemotherapy (T-DXd and T-DM1) in women with HER2-positive metastatic breast cancer who had already received trastuzumab and a taxane. After more than three years of follow-up, with T-DXd the disease stayed under control for a median of about 29 months (versus 7 months), and median survival was also about 10 months longer. Lung inflammation is an important side effect that should be reported to the doctor early. Treatment decisions should be made with the treating doctor.
HER2-positive after prior anti-HER2 therapy; HER2-low (IHC 1+ or 2+ with negative ISH) after prior chemotherapy; HR-positive HER2-low or HER2-ultralow (IHC 0 with membrane staining) after one or more lines of hormone therapy
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Trastuzumab deruxtecan (T-DXd) | 5.4 mg/kg | IV | Day 1 |
On the page “Breast cancer” · Advanced HER2-positive and HER2-low disease
Metastatic HER2-positive or HER2-low breast cancer
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Trastuzumab deruxtecan | 5.4 mg/kg | IV (first dose over 90 minutes, then 30 minutes) | Day 1 |
Dose as in DESTINY-Breast03. Dose reduction: 4.4, then 3.2 mg/kg.
Dose source:.
On the page “Trastuzumab deruxtecan (T-DXd, Enhertu): dose and monitoring”
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Trastuzumab deruxtecan 5.4 mg/kg IV every 3 weeks until progression or unacceptable toxicity (261 patients).
Trastuzumab emtansine 3.6 mg/kg IV every 3 weeks per the label (263 patients).
Source of the regimen details: Full text of the paper (Nat Med 2024; open access PMC11333275) and ClinicalTrials.gov NCT03529110
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients with advanced HER2-positive metastatic breast cancer previously treated with a taxane and trastuzumab.
Primary endpoint: progression-free survival by independent central review (previously reported). Key secondary endpoint: overall survival. Other secondary endpoints: objective response rate, duration of response, investigator-assessed progression-free survival and safety.
Treatment-emergent grade 3 or higher adverse events in 58.0% of the T-DXd group and 52.1% of the T-DM1 group (48.6% and 42.5% drug-related, respectively); discontinuation due to drug-related adverse events 22.6% versus 7.3%. Adjudicated interstitial lung disease/pneumonitis in 16.7% versus 3.4% (grade 3: 0.8% versus 0.4%; no grade 4 or 5); no new grade 3 or higher cases since the previous data cut-off.
This long-term analysis confirms the superiority of T-DXd over T-DM1 in overall survival as well and establishes T-DXd as the preferred second-line treatment for HER2-positive metastatic breast cancer.
The trial was open-label; some endpoints in this report are investigator-assessed and secondary/exploratory. Details of the dosing schedule and adverse events are in the full text.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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