Validation of 70-gene MammaPrint Profile in Japanese Population

This study has been completed.
Sponsor:
Collaborator:
Osaka General Medical Center
Information provided by:
Agendia
ClinicalTrials.gov Identifier:
NCT00904566
First received: May 18, 2009
Last updated: June 14, 2011
Last verified: June 2011
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Validation 70-gene MammaPrint Profile in Japanese Population

Resource links provided by NLM:


Further study details as provided by Agendia:

Primary Outcome Measures:
  • The probability of recurrence free survival (PRFS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: April 2008
Study Completion Date: January 2009
Detailed 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.

  Eligibility

Ages Eligible for Study:   29 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Breast cancer patients, node-negative, treated with breast conserving therapy or mastectomy with axilary lymph node dissection at Osaka Medical Center for Cancer and Cardiovascular Diseases.

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00904566

Locations
Japan
Osaka Medical Center for Cancer and Cadiovascular Diseases
Osaka, Japan
Sponsors and Collaborators
Agendia
Osaka General Medical Center
Investigators
Study Chair: Kikuya Kato, MD, PhD, Prof Osaka Medical Center for Cancer and Cardiovascular Diseases
  More Information

Additional Information:
No publications provided

Responsible Party: Kikuya Kato, MD, PhD, Prof, Osaka Medical Center for Cancer and Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT00904566     History of Changes
Other Study ID Numbers: MP-107-RR
Study First Received: May 18, 2009
Last Updated: June 14, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by Agendia:
microarray
gene expression profiling
MammaPrint
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014