Trial Information

Screening and Management of Cardiovascular Risk in Belgian Women Aged > or = 65 Years With Metastatic Breast Cancer Before and After Anthracycline Treatment

The physician will be requested:

- To include 16 consecutive patients aged > or = 65 years who will be treated with
anthracyclines in first and second line MBC. The physician will be encouraged to enrol
2 arms of 8 patients (one treated with liposomal and one with non-liposomal
anthracyclines) for observation and comparison. Each arm will be closed as soon as 160
patients are included at a national level.

- To report their cardiovascular risk factors

- To provide the results of routinely performed cardiac evaluation before treatment

- To monitor routinely cardiovascular parameters during treatment and report them
afterwards

- To monitor efficacy and tolerance of treatments, as normal practice prescribes,
reported and related to the variables described in objectives

- To ensure that quality of life will be assessed with the EORTC QLQ-C30 questionnaire

- To monitor and report progression free survival and cardiac events

- To record and transmit spontaneously reported adverse events. These will be handled
according to legal requirements

Follow-up will cover a period of 15 months following inclusion.

The study will have 3 visits and 2 contacts:

- One visit at entry

- One visit after 3 cycles of anthracycline containing therapy

- One visit at the end of treatment

- Contact at 9 months after inclusion

- Contact at 15 months after inclusion

It is planned to include data from 16 consecutive female patients per specialized center in
Belgium.

The total number of patients aimed is 320.