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Validation of 70-gene MammaPrint Profile in Japanese Population

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ClinicalTrials.gov Identifier: NCT00904566
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : June 23, 2015
Sponsor:
Collaborator:
Osaka General Medical Center
Information provided by (Responsible Party):
Agendia

Brief 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.

Condition or disease
Breast Cancer

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.

Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Validation 70-gene MammaPrint Profile in Japanese Population
Study Start Date : April 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The probability of recurrence free survival (PRFS) [ Time Frame: 5 years ]


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Ages Eligible for Study:   29 Years to 70 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Agendia
ClinicalTrials.gov Identifier: NCT00904566     History of Changes
Other Study ID Numbers: MP-107-RR
First Posted: May 19, 2009    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

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