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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
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
 Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Search for Genetic Factors Predictive of Response to Chemotherapy in Patients With or Who Has a Mammary Adenocarcinoma in Neo-adjuvant or Metastatic Setting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Histologic complete response (Chevallier and Sataloff) or tumor response (RECIST) [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: November 2007
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959556

Locations
France
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Jacques Bonneterre, MD, PhD     33-3-20-29-5959     j.bonneterre@o-lambret.fr    
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Jacques Bonneterre, MD, PhD Centre Oscar Lambret
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00959556     History of Changes
Other Study ID Numbers: CDR0000633531, COL-GENEOM, COL-IDRCB-2007-A00908-45, COL-2007-08, INCA-RECF0635
Study First Received: August 13, 2009
Last Updated: January 7, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
 stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

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

ClinicalTrials.gov processed this record on May 23, 2013