Study of Tumor and Blood Samples From Women With Breast Cancer
NCT ID: NCT00897728
Last Updated: 2010-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
180 participants
OBSERVATIONAL
2008-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This research study is looking at tumor and blood samples from women with breast cancer.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary
* Assess relapse locally or remotely using biomarkers collected from primary tumor and blood samples from women with breast cancer during the first 2 years after diagnosis.
Secondary
* Evaluate all relapses.
* Assess survival without relapse.
* Determine correlation between biomarkers and relapse.
OUTLINE: Primary tumor and blood samples collected during usual care of patients during the first 2 years after diagnosis are analyzed for biomarkers useful in monitoring and diagnosing breast cancer.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
laboratory biomarker analysis
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of infiltrating unilateral breast cancer
* No in situ disease (ductal or lobular)
* No invasive bilateral synchronous disease
* Breast cancer at high risk, defined by at least 2 of the following factors:
* Hormone receptor negative (HR-)
* Axillary node positive
* Histopathologic grade III
* High mitotic index (as defined by the Curie Institute as \> 20 mitoses per 10 high-power fields \[HPF\])
* Tumor size ≥ 2 cm
* HER2-positive (3 + IHC or FISH/ICHS positive)
* Triple-negative tumors (HR- and HER2-negative)
* Initial thoracic-abdomino-pelvic and bone scans must be negative
* Underwent initial surgery
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* Serum calcium normal (15.3 mg/dL) or normalized within 8 weeks after surgery
* No other invasive cancer within the past 5 years
* Not pregnant or nursing
* No psychological, familial, social, or geographical reasons that make monitoring impossible
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut Curie
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paul-Henri Cottu
Role: STUDY_CHAIR
Institut Curie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut Curie Hopital
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Paul-Henri Cottu
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLCC-IC-COBRED-SEIN
Identifier Type: -
Identifier Source: secondary_id
CLCC-IC-2007-11
Identifier Type: -
Identifier Source: secondary_id
CLCC-RECF0632
Identifier Type: -
Identifier Source: secondary_id
CDR0000599189
Identifier Type: -
Identifier Source: org_study_id