An Observational Study on Human Epidermal Growth Factor Receptor (HER) 2 Status of Breast Invasive Carcinoma in Latin American Participants

Roche

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02535026

ML25371

Details and patient eligibility

About

This is a descriptive, prospective, observational and epidemiological study on participants recently diagnosed with breast cancer to evaluate the HER2 status by IHC and SISH procedures.

Enrollment: 580 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Anatomopathological samples (surgical specimens or when a surgical sample is not possible, a core needle biopsy may be used) from female participants with a histopathological diagnosis of invasive breast cancer

Exclusion criteria

• Samples whose residual material in the paraffin block(s) is insufficient for neoplasm representation in the procedures in this study
• Cancer samples that have received previous chemotherapy treatment

Trial design

580 participants in 1 patient group

Breast Cancer Participants

Description:

Breast tissue samples from female participants with a breast cancer diagnosis that undergo an anatomopathological examination of surgical specimens and/or core needle biopsies will be considered for analysis in this study.