Blood Levels of Tumor Cells in Predicting Response in Patients Receiving First-Line Chemotherapy for Stage IV Breast Cancer - Full Text View

Sponsored by:	Institut Curie Hopital
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00898014

Purpose

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.

Condition	Intervention
Breast Cancer	Genetic: fluorescence in situ hybridization Other: immunologic technique Other: laboratory biomarker analysis

Study Type:	Observational
Official Title:	Study Evaluating the Prognostic and Predictive Value of Response to First-Line Chemotherapy by Detection of Circulating Tumor Cells (CTC) in Patients With Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Correlation of circulating tumor cells (CTC) with overall survival [ Designated as safety issue: No ]
Correlation of CTC with progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlation of circulating tumor cells with tumor markers, clinical response, and radiological response [ Designated as safety issue: No ]
Change in HER-2 status in patients receiving trastuzumab (Herceptin®) [ Designated as safety issue: No ]

Estimated Enrollment:	216
Study Start Date:	May 2007

Detailed Description:

OBJECTIVES:

Primary

Predict the overall and progression-free survival of patients with stage IV breast cancer by measuring the rate of circulating tumor cells (CTC) before the second course of chemotherapy.

Secondary

Predict overall and progression-free survival of these patients by measuring the rate of CTC before the start of chemotherapy, at the first tumor evaluation, and after 2-3 courses of chemotherapy.
Correlate the detection of CTC with tumor markers, clinical response, and radiological response.
Study the changing status of HER-2 in CTC in patients receiving trastuzmab (Herceptin®).

OUTLINE: This is a multicenter study.

Blood samples are collected at baseline, before the second course of chemotherapy, before the third or fourth course of chemotherapy, and when progressive disease is diagnosed (before second-line treatment is initiated).

Circulating tumor cells from the blood samples are examined by immunofluorescence.

Patients are followed periodically for up to 3 months.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898014

Locations

France
Institut Curie Hopital	Recruiting
Paris, France, 75248
Contact: Jean-Yves Pierga, MD, PhD 33-1-4432-4672

Sponsors and Collaborators

Institut Curie Hopital

Investigators

Study Chair:

Jean-Yves Pierga, MD, PhD

Institut Curie Hopital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000574195, CLCC-IC-2006-04, INCA-RECF0474
Study First Received:	May 9, 2009
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00898014 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IV breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009