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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014