Breast CancerNCT00904566
Validation of 70-gene MammaPrint Profile in Japanese Population
An observational study of Breast Cancer, run by Agendia at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 29 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 102 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2008to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation 70-gene MammaPrint Profile in Japanese Population
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.
- Conditions
- Breast Cancer
- Keywords
- microarray, gene expression profiling, MammaPrint, breast cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The probability of recurrence free survival (PRFS)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startApr 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agendia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Osaka General Medical Center
- Responsible party
- Sponsor
- Investigators
- Kikuya Kato, MD, PhD, Prof, Study chair, Osaka Medical Center for Cancer and Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904566
- Sponsor's protocol ID
- MP-107-RR
- Status last verified
- Jun 2015
- First submitted
- 18 May 2009
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation 70-gene MammaPrint Profile in Japanese Population
- ClinicalTrials.gov ID
- NCT00904566
- Acronym / sponsor ID
- MP-107-RR
- Conditions
- Breast Cancer
- Keywords
- microarray, gene expression profiling, MammaPrint, breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- AgendiaIndustry (pharma, biotech, devices)
- Collaborators
- Osaka General Medical Center
- Study start
- Apr 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 29 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The probability of recurrence free survival (PRFS)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kikuya Kato, MD, PhD, Prof study chair
Osaka Medical Center for Cancer and Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Agendia at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The probability of recurrence free survival (PRFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.