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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00898014
• Lead Sponsor: Institut Curie

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.

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Status Verified: 2009-07
• Primary Completion: 2010-04
• Last Update Submitted: 2011-05-12
• Last Update Posted: 2011-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of circulating tumor cells (CTC) with overall survival
Correlation of CTC with progression-free survival

Secondary Outcome Measures

Name	Time	Method
Correlation of circulating tumor cells with tumor markers, clinical response, and radiological response
Change in HER-2 status in patients receiving trastuzumab (Herceptin®)

Trial Locations

Locations (1)

Institut Curie Hopital; 🇫🇷 Paris, France