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Study of Blood Samples in Patients With Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00959556
First received: August 13, 2009
Last updated: January 7, 2011
Last verified: August 2009

August 13, 2009
January 7, 2011
November 2007
December 2011   (final data collection date for primary outcome measure)
Histologic complete response (Chevallier and Sataloff) or tumor response (RECIST) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00959556 on ClinicalTrials.gov Archive Site
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Study of Blood Samples in Patients With Breast Cancer
Search for Genetic Factors Predictive of Response to Chemotherapy in Patients With or Who Has a Mammary Adenocarcinoma in Neo-adjuvant or Metastatic Setting

RATIONALE: Studying the genes expressed in samples of blood from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to chemotherapy.

PURPOSE: This clinical trial is studying blood samples in patients with breast cancer.

OBJECTIVES:

  • Identify constitutional gene variants associated with a change in response.

OUTLINE: Blood samples are collected periodically for analysis of genetic factors.

Observational
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Breast Cancer
Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
900
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December 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast carcinoma
  • Received first-line chemotherapy (in neoadjuvant or metastatic setting) comprising anthracyclines and/or taxanes, including for a second primary cancer
  • Patient agrees to conservative surgery
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • No contraindication for chemotherapy comprising anthracyclines and/or taxanes

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior adjuvant therapy
Female
18 Years and older
No
France
 
NCT00959556
CDR0000633531, COL-GENEOM, COL-IDRCB-2007-A00908-45, COL-2007-08, INCA-RECF0635
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Centre Oscar Lambret
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Principal Investigator: Jacques Bonneterre, MD, PhD Centre Oscar Lambret
National Cancer Institute (NCI)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP