NCT00904566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

9 months

First QC Date

May 18, 2009

Last Update Submit

June 22, 2015

Conditions

Breast Cancer

Keywords

microarraygene expression profilingMammaPrintbreast cancer

Outcome Measures

Primary Outcomes (1)

  • The probability of recurrence free survival (PRFS)

    5 years

Eligibility Criteria

Age29 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka Medical Center for Cancer and Cadiovascular Diseases

Osaka, Japan

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kikuya Kato, MD, PhD, Prof

    Osaka Medical Center for Cancer and Cardiovascular Diseases

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 19, 2009

Study Start

April 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

JP(1)