375P - Results from the Danish Breast Cancer Group's (DBCG) NAME-trial: A direct comparison of oral navelbine given either classic or metronomic in metastatic breast cancer

Background

The NAME study aims at investigating whether the treatment with Navelbine, according to the metronomic principle, is superior to conventional treatment in terms of efficacy and safety. The study has the EUDRACT no: 2016-002165-63. In addition to better efficacy, preliminary studies show treatment with frequent small dosages, not only have an effect on the tumour cells, but also, an effect on the angiogenesis and the immune cells.

Methods

The NAME trial is an open randomized multicentre phase II study. We included 163 patients with HER2 normal metastatic breast cancer in Denmark from 2017-2022. Both patients with Estrogenic receptor (ER) positive and ER negative tumours were included in the study. The randomisation is between the standard Arm A, where the patients are treated with Vinorelbine (Navelbine Oral^â): 60 mg/m² day 1 and day 8, every three weeks for the first cycle. Hereafter 80 mg/m² in the following cycles. In the metronomic experimental Arm B, the patients receive Vinorelbine (Navelbine Oral^â): daily doses of Navelbine. The start dose is 30 mg per day. Reduction is possible.

Results

The patients were well balanced between the two arms. Median age were 68-69 years. Primarily performance status 0-1. The adverse events found in the study shows the two regimes were both well tolerated with mostly low-grade adverse events. We found a median progression free survival (PFS) in arm A of 3.9 months (95% CI 3.4-4.5) and a median PFS in arm B of 2.3 months (95% CI 1.5-3.0). The difference was non-significant (P=0.236). The median overall survival (OS) was 16.63 months (95% CI 14.66-18.61) in arm A and 15.13 months (95% CI 12.11-18.16) in arm B. Also, non-significant (P=0.355).

Conclusions

The study was conducted in order investigate metronomic chemotherapy using a randomized trial design. There was no significant difference between the two arms regarding effect. No new signals regarding safety were observed. While metronomic chemotherapy may offer certain advantages, our findings could not demonstrate any benefit, when using Navelbine in advanced breast cancer patients in this particular investigator initiated, multicentre, Danish randomised controlled trial, the NAME trial.

Clinical trial identification

EudraCT 2016-002165-63 The NAME trial.

Editorial acknowledgement

Legal entity responsible for the study

Anne Sofie Brems-Eskildsen.

Funding

Pierre Fabre, Overture's Torg 1, Plan 2 SE-19147 Sollentuna Sweden.

Disclosure

All authors have declared no conflicts of interest.