In this large study, women with HER2-positive breast cancer who had finished surgery and chemotherapy either received a drug called trastuzumab (Herceptin) for one year or were only monitored and followed up. Women who received trastuzumab were less likely to have their cancer come back or related events. A serious heart problem occurred in about 0.5% of them. At the time of this first analysis, no significant difference in overall survival was seen.
Adjuvant treatment, within 3 weeks of completing multimodality anthracycline-based chemotherapy
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Trastuzumab | Initial dose 8 mg/kg, then 6 mg/kg | IV infusion; initial 90 minutes, then 30 to 90 minutes | Every 3 weeks |
On the page “Trastuzumab (Herceptin)” · Dose and schedule (FDA label)
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 every three weeks for one year.
Trastuzumab IV at an initial dose of 8 mg/kg, then 6 mg/kg every 3 weeks for 1 year, after definitive surgery and at least 4 cycles of chemotherapy (and radiotherapy after breast-conserving surgery); endocrine therapy for ER/PR-positive disease at the investigator's discretion.
Trastuzumab every three weeks for two years. The results of this group are not presented in this report.
The same doses (8 then 6 mg/kg every 3 weeks) for 2 years; according to the label, continuing trastuzumab for more than 1 year is not recommended.
Follow-up and observation only, without trastuzumab.
Source of the regimen details: FDA label for Herceptin (DailyMed, section 14.1, HERA)
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.
Women with HER2-positive breast cancer, with or without lymph node involvement, who had completed locoregional treatment and received at least four cycles of neoadjuvant or adjuvant chemotherapy.
The abstract does not explicitly name the primary endpoint; events included recurrence of breast cancer, contralateral breast cancer, a second non-breast malignancy or death, and disease-free survival was assessed. Overall survival and severe cardiotoxicity were also reported.
Severe cardiotoxicity occurred in 0.5% of women treated with trastuzumab. Other adverse events are not reported in the abstract.
These results showed that one year of trastuzumab after adjuvant chemotherapy improves disease-free survival in early HER2-positive breast cancer, and severe cardiotoxicity was rare. The exact status of approvals and clinical guideline recommendations should be checked separately, as they are not given in the abstract.
This report is the first interim analysis with a short median follow-up (one year). The effect on overall survival was not yet significant, and the two-year trastuzumab group was not analysed in this report.
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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