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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Locations

France

Study Type

Observational

Intervention

fluorescence in situ hybridization

immunologic technique

laboratory biomarker analysis

About this trial

This is an observational trial for Breast Cancer focused on measuring stage IV breast cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institut Curie Hopital

Outcomes

Primary Outcome Measures

Correlation of circulating tumor cells (CTC) with overall survival

Correlation of CTC with progression-free survival

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT00898014

First Posted

May 9, 2009

Last Updated

May 12, 2011

Sponsor

Institut Curie

1. Study Identification

Unique Protocol Identification Number

NCT00898014

Brief Title

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

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Institut Curie

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

stage IV breast cancer

7. Study Design

Enrollment

216 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Genetic

Intervention Name(s)

fluorescence in situ hybridization

Intervention Type

Other

Intervention Name(s)

immunologic technique

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Primary Outcome Measure Information:

Title

Correlation of circulating tumor cells (CTC) with overall survival

Title

Correlation of CTC with progression-free survival

Secondary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Yves Pierga, MD, PhD

Organizational Affiliation

Institut Curie

Official's Role

Study Chair

Facility Information:

Facility Name

Institut Curie Hopital

City

Paris

ZIP/Postal Code

75248

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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