ML40006 HEROLD
A prospective, non-interventional study assessing the diagnostic, therapeutic proceedings and safety of anti-HER2 treatment in elderly patients (≥70 years old) with HER2 positive breast cancer in routine clinical practice in Poland - multicenter, observational study.

Dear Sir and Madam

Breast cancer is the most common malignant tumor in women, with a global prevalence of more than 1 million patients. The annual mortality rate is approximately 450,000 deaths (American Cancer Society).

Due to the growing average life expectancy of women in Poland, population of elderly females is increasing significantly. According to the Central Statistical Office (CSO) forecast, the number of women over the age of 65 years will increase from 3.65 million in 2015 to 4.94 million in 2030. Currently there is a relative lack of data from studies specifically designed for elderly population, which would be able to address the question of safety, tolerance and efficiency of therapeutic choices of HER family agents.

There is a need for comprehensive assessment of the course of anti-HER2 targeted therapies (Herceptin SC or Herceptin IV with or without Perjeta) in the population of older women that focuses on safety and tolerance of the treatment. For this reason, we would like to invite you to participate in the study named: A prospective, non-interventional study assessing the diagnostic, therapeutic proceedings and safety of anti-HER2 treatment in elderly patients (≥70 years old) with HER2 positive breast cancer in routine clinical practice in Poland - multicenter, observational study (HEROLD).

The most vital aspect of such study is broadening of knowledge about adverse events affecting this population as well as frequency of discontinuations of anti-HER2 treatment caused by adverse events. At the same time there is a need for appraisal of what part of the population of patients with HER2 positive breast cancer at the age of 70 years or above is not qualified for chemotherapy and targeted therapies and what are reasons of disqualification from anti-HER2 therapy.

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CRA:
Katarzyna Kuczyńska
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Sponsor:
Magdalena Wójcik-Kacprzak
Study Scientific Responsible
+48 22 2605415, 519 514 985
magdalena.wojcik-kacprzak@roche.com

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