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NCT00904566 Clinical Trial

Validation of 70-gene MammaPrint Profile in Japanese Population

Breast Cancer Clinical Trial

Official title:
Validation 70-gene MammaPrint Profile in Japanese Population

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00904566
Other study ID # MP-107-RR
Secondary ID
Status Completed
Phase N/A
First received May 18, 2009
Last updated June 22, 2015
Start date April 2008
Est. completion date January 2009

Study information
Verified date June 2015
Source Agendia
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Observational

Clinical Trial Summary

By using gene-expression profiling, Van't Veer and colleagues developed a 70-gene prognosis profile, MammaPrint, to identify breast cancer patients who are at low risk of developing distant metastases and therefore might safely be spared chemotherapy. The aim of this study is to evaluate the prognostic value of the 70-gene Mammaprint profile in Japanese women with node-negative breast cancer.

Description:

Frozen tumor samples from 140 node-negative, breast cancer patients aged between 29 and 70 years at diagnosis are hybridized on MammaPrint array. Patients were treated with breast conserving therapy or mastectomy with axillary lymph node dissection between December 1998 and August 2001 at Osaka Medical Center for Cancer and Cardiovascular Diseases. Samples are evaluated by gene expression profiling for the 70-gene MammaPrint profile and classified as genomic high risk or genomic low risk.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Female
Age group 29 Years to 70 Years
Eligibility Inclusion Criteria:

- Breast cancer patients

- Node-negative

- Treated with breast conserving therapy or mastectomy with axillary lymph node dissection at Osaka Medical Center for Cancer and Cardiovascular Diseases

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Osaka Medical Center for Cancer and Cadiovascular Diseases Osaka

Sponsors (2)
Lead Sponsor Collaborator
Agendia Osaka General Medical Center

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The probability of recurrence free survival (PRFS) 5 years No
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