Validation of 70-gene MammaPrint Profile in Japanese Population

NCT ID: NCT00904566

Last Updated: 2015-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

29 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Osaka General Medical Center

OTHER

Sponsor Role collaborator

Agendia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kikuya Kato, MD, PhD, Prof

Role: STUDY_CHAIR

Osaka Medical Center for Cancer and Cardiovascular Diseases

Locations

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Osaka Medical Center for Cancer and Cadiovascular Diseases

Osaka, , Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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MP-107-RR

Identifier Type: -

Identifier Source: org_study_id

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