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.

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

Study Overview

• Status: Completed
• Conditions: Chinese

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.

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women of Chinese Descent with Stage I or Stage II Breast Cancer

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Women of Chinese Descent; Females of Chinese descent, aged 18 year to 70 year, diagnosed with Stage 1 or Stage 2 (excluding those involving more than 3 lymph nodes) breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Agendia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Breast cancer; Chinese women
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: P-0125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED