Clinical trial NCT00898014: Blood Levels of Tumor Cells in Predicting Response in Patients Receiving First-Line Chemotherapy for Stage IV Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: stage IV breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-05-12
Enrollment: 216
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

Eligibility 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

Primary outcomes:
measure: Correlation of circulating tumor cells (CTC) with overall survival
measure: Correlation of CTC with progression-free survival
Secondary outcomes:
measure: Correlation of circulating tumor cells with tumor markers, clinical response, and radiological response
measure: Change in HER-2 status in patients receiving trastuzumab (Herceptin®)
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie Hopital
Study officials:
affiliation: Institut Curie
name: Jean-Yves Pierga, MD, PhD
role: STUDY_CHAIR
References: