NCT00897728

Brief Summary

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at tumor and blood samples from women with breast cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Last Updated

December 1, 2010

Status Verified

July 1, 2009

Enrollment Period

2 years

First QC Date

May 9, 2009

Last Update Submit

November 30, 2010

Conditions

Breast Cancer

Keywords

stage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerHER2-positive breast cancertriple-negative breast cancerestrogen receptor-negative breast cancer

Outcome Measures

Primary Outcomes (1)

  • Local or remote relapse as assessed by biomarkers in tissue and blood samples collected during the first 2 years after diagnosis

Interventions

laboratory biomarker analysisOTHER

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Institut Curie Hopital

Paris, 75248, France

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Paul-Henri Cottu

    Institut Curie

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

February 1, 2008

Primary Completion

February 1, 2010

Last Updated

December 1, 2010

Record last verified: 2009-07

Locations

FR(1)