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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00898014
First received: May 9, 2009
Last updated: May 12, 2011
Last verified: July 2009
  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:


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
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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
Paris, France, 75248
Sponsors and Collaborators
Institut Curie
Investigators
Study Chair: Jean-Yves Pierga, MD, PhD Institut Curie
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00898014     History of Changes
Other Study ID Numbers: CDR0000574195, CLCC-IC-2006-04, INCA-RECF0474
Study First Received: May 9, 2009
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014