DEVA

A Multicentre Randomised Trial of Sequential Epirubicin and Docetaxel versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients

Countries involved in the trial highlighted in dark blue: UK, France, Netherlands, Spain and Malta.

Aims:

1. All Patients: To determine the impact of sequential chemotherapy (Epirubicin and Docetaxel) in comparison with a standard regimen (Epirubicin).
2. Optional by centre: To determine the impact of giving tamoxifen concurrently with chemotherapy versus sequential administration of tamoxifen.

 Study Design:

All ER positive and/or PgR positive-patients will receive tamoxifen for five years. In selected centres, the timing of the start of treatment with tamoxifen is randomised between:

 ARM 1:      Concurrent tamoxifen – tamoxifen to be started at the same time as starting chemotherapy
[Patients already receiving tamoxifen at the time of randomisation should continue with their tamoxifen treatment.]

ARM 2:      Sequential tamoxifen - tamoxifen to be started at the end of chemotherapy
[Patients already receiving tamoxifen at the time of randomisation should be asked to stop taking tamoxifen and to restart it on completion of their chemotherapy]

a  switch to an aromatase inhibitor, according to local institutional policy, is permitted

 

 

Endpoints:

Primary End Point:  Disease free survival (DFS)

                                    Overall Survival (OS)

Optional by Cente    Incidence of thromboembolic events (up to 9 months post-randomisation)

Secondary End Point:  Toxicity

Optional by Centre        Quality of Life (QL)

All analyses will be by intention to treat.

 

Recruitment:

Recruitment closed on the 10th August 2005 - Final Accrual into the main study: 803

                                                                   Final Accrual into QL Study: 296

Status:

DEVA is in active long term follow up