The Study of Molecular Risk Panels (70-gene Assay) in Chinese Breast Cancer Patients

Chinese Clinical Trial

Official title:

The Study of Molecular Risk Panels in Chinese Breast Cancer Patient Using Mammaprint, TargetPrint, BluePrint and Research Gene Panel Assays.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02669745
• Other study ID #: P-0125
• Status: Completed
• Start date: January 2012
• Est. completion date: May 2019

Study information

• Verified date: July 2019
• Source: Agendia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is experimental and will prospectively assess the proportion of patients in the two (2) MammaPrint Risk categories in patients of Chinese descent.

Description:

The incidence of breast cancer in Chinese women is lower than that of a Western population. Breast cancer is the most common cancer in Chinese women and the incidence is rising. Moreover there are more premenopausal women with breast cancer where the breast cancer incidence peaks in the forties and the postmenopausal rise in incidence is less commonly seen. As the genetic predisposition to breast cancer is increasingly understood, it has been suggested that the differences in breast cancer incidence in different ethnic populations is potentially due to interactions between lifestyle and genetic characteristics. To date, the use of Agendia's gene expression assays in Chinese women has not been studied. In this study, the feasibility of the gene-expression prognostic assays for risk assessment in this specific group will be assessed. Moreover, the specific molecular characteristics and potential biomarkers will be studied, focusing especially on the large group of premenopausal breast cancer patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Females aged 18 year to 70 year,

• diagnosis of Stage I or Stage II (excluding those involving more than 3 lymph nodes) Breast Cancer

• Chinese descent

Exclusion Criteria:

• Stage II Breast Cancer with more than 3 positive lymph nodes

Related Conditions & MeSH terms

• Breast Neoplasms
• Chinese

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Agendia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing MammaPrint with Clinical Risk Assessment	The MammaPrint risk assessment outcomes will be compared with conventionally used risk assessments determined by clinical parameters, standard staging and IHC analysis (Adjuvant! Online) in a population of Chinese patients with breast cancer.	6 weeks