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CompletedNCT00904566Updated Jun 23, 2015

Validation of 70-gene MammaPrint Profile in Japanese Population

An observational study in Breast Cancer, sponsored by Agendia. Completed at 1 site in Japan. Open to female participants aged 29 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-06-23.

Sponsored by Agendia · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
102
Ages
29 Years to 70 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Breast Cancer

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Keywords

  • microarray
  • gene expression profiling
  • MammaPrint
  • breast cancer
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 102 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Agendia is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
29 Years to 70 Years
Sexes eligible
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.

Eligibility 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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
102 participants (actual)
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What researchers measure

Primary outcomes

  1. The probability of recurrence free survival (PRFS)

    Time frame: 5 years

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Study locations

1 site
  • Osaka Medical Center for Cancer and Cadiovascular Diseases
    Osaka, Japan
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References and documents

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00904566
Lead sponsor
Agendia
Collaborators
Osaka General Medical Center
Responsible party
Sponsor
First posted
May 19, 2009
Start date
Apr 2008
Primary completion
Jan 2009
Completion
Jan 2009
Last update
Jun 23, 2015

Study contacts

Kikuya Kato, MD, PhD, Prof
study chair · Osaka Medical Center for Cancer and Cardiovascular Diseases

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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