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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02669745

Enrollment

Registered

2016-02-01

Start date

2012-01-31

Completion date

2019-05-31

Last updated

2019-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chinese

Keywords

Chinese women, Breast cancer

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Comparing MammaPrint with Clinical Risk Assessment	6 weeks	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.

Countries

United States

Outcome results