NCT00898014

Brief Summary

RATIONALE: Measuring blood levels of tumor cells in patients with breast cancer may help doctors predict how patients will respond to treatment. PURPOSE: This laboratory study is looking at blood levels of tumor cells in predicting response in patients receiving first-line chemotherapy for stage IV breast cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2 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
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Last Updated

May 13, 2011

Status Verified

July 1, 2009

Enrollment Period

2.9 years

First QC Date

May 9, 2009

Last Update Submit

May 12, 2011

Conditions

Breast Cancer

Keywords

stage IV breast cancer

Outcome Measures

Primary Outcomes (2)

  • Correlation of circulating tumor cells (CTC) with overall survival

  • Correlation of CTC with progression-free survival

Secondary Outcomes (2)

  • Correlation of circulating tumor cells with tumor markers, clinical response, and radiological response

  • Change in HER-2 status in patients receiving trastuzumab (Herceptin®)

Interventions

fluorescence in situ hybridizationGENETIC
immunologic techniqueOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of stage IV breast cancer * Measurable or evaluable disease * Scheduled to receive first-line chemotherapy with or without trastuzumab (Herceptin®), depending on HER-2 status * Histologic block available for confirming pathologic diagnosis and measuring HER-2 status via FISH PATIENT CHARACTERISTICS: * Life expectancy \> 3 months * No other cancer in the past 5 years except for basal cell skin cancer or epithelial in situ cancer of the cervix * No geographic, social, or psychiatric reasons that would make treatment impossible PRIOR CONCURRENT THERAPY: * No prior chemotherapy for metastatic disease

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

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

In Situ Hybridization, FluorescenceImmunologic Techniques

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

In Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid Hybridization

Study Officials

  • Jean-Yves Pierga, MD, PhD

    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

May 1, 2007

Primary Completion

April 1, 2010

Last Updated

May 13, 2011

Record last verified: 2009-07

Locations

FR(1)