An Observational Study on HER2 Status of Breast Invasive Carcinoma in Latin American Participants

Breast Cancer Clinical Trial

Official title:

Epidemiological, Prospective and Observational Study on the HER2 Status in Breast Invasive Carcinomas Assessed by Immunohistochemistry (IHC) and Silver In-situ Hybridization (SISH) in a Sample of Latin-American Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535026
• Other study ID #: ML25371
• Status: Completed
• Phase: N/A
• First received: August 26, 2015
• Last updated: April 2, 2016
• Start date: July 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Peru: Ministerio de Salud del Perú (MINSA)Uruguay: Ministerio de Salud Publica (MSP)
• Study type: Observational

Clinical Trial Summary

This is a descriptive, prospective, observational and epidemiological study on participants recently diagnosed with breast cancer to evaluate the human epidermal growth factor receptor 2 (HER2) status by immunohistochemistry (IHC) and silver in-situ hybridization (SISH) procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Peru,  Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Human Epidermal Growth Factor (HER2) Status in Breast Cancer Specimens Using Immunohistochemistry (IHC) and Silver In-Situ Hybridization (SISH) Procedures		Up to 30 months	No
Primary	Assessment of Different Phenotypes of Breast Cancer		Up to 30 months	No
Primary	Histological Sub-types of Breast Cancer		Up to 30 months	No
Primary	Correlation of Estrogen Receptor (ER) Status and Clinicopathological Variables		Up to 30 months	No
Primary	Correlation of Progesterone Receptor (PgR) Status and Clinicopathological Variables		Up to 30 months	No
Primary	Correlation of HER2 Status and Clinicopathological Variables		Up to 30 months	No
Primary	Correlation of Breast Cancer Phenotypes with Clinicopathological Variables		Up to 30 months	No
Primary	Distribution of Breast Cancer Phenotypes Among Different Hispanic Countries		Up to 30 months	No