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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898014
• Other study ID #: CDR0000574195
• Secondary ID: CLCC-IC-2006-04I
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: May 12, 2011
• Start date: May 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• fluorescence in situ hybridization

Other:
• immunologic technique

• laboratory biomarker analysis

Locations

Country	Name	City	State
France	Institut Curie Hopital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of circulating tumor cells (CTC) with overall survival			No
Primary	Correlation of CTC with progression-free survival			No
Secondary	Correlation of circulating tumor cells with tumor markers, clinical response, and radiological response			No
Secondary	Change in HER-2 status in patients receiving trastuzumab (Herceptin®)			No