A Study on the Epidemiology and Testing of Human Epidermal Growth Factor-Receptor 2 (HER2) in Breast Cancer in Germany

Roche

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02666261

ML29763

Details and patient eligibility

About

This non-interventional study will collect data from routine diagnostics on HER2 testing of breast cancer in Germany.

Enrollment: 15,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Samples derived from men and women of age greater than or equal to (>/=) 18 years
• Samples derived from participants with any stage of histologically confirmed invasive breast cancer with HER2 diagnostics performed within routine (histo-)pathological workup or
• (Histo-)Pathological work-up of the tumor sample as at or after start of this study
• Available information on the year of birth of the participant
• No pre-selection of tumor samples is allowed. Tumor samples have to be documented consecutively in the order of their (histo-)pathological work-up.

Exclusion criteria

• Sample derived from participants with any stage of breast cancer with no HER2 diagnostics performed at the time of routine (histo-)pathological work-up.
• Samples derived prior to the start of this study.

Trial design

15,000 participants in 1 patient group

Breast Cancer Pathology Samples

Description:

Data on the epidemiology and HER2 testing of breast cancer will be collected from pathology routine diagnostics.