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.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Christel Fontaine, MD
Principal Investigator
University Hospital, Brussels
Belgium: Ethics Committee
MyCard
NCT01555944
February 2012
April 2015
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