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Study of Blood Samples in Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT00959556
Recruitment Status : Unknown
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : August 14, 2009
Last Update Posted : January 10, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Breast Cancer Other: laboratory biomarker analysis

Detailed Description:

OBJECTIVES:

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

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


Study Design

Study Type : Observational
Estimated Enrollment : 900 participants
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
Study Start Date : November 2007
Estimated Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Histologic complete response (Chevallier and Sataloff) or tumor response (RECIST)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00959556     History of Changes
Other Study ID Numbers: CDR0000633531
COL-GENEOM
COL-IDRCB-2007-A00908-45
COL-2007-08
INCA-RECF0635
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: January 10, 2011
Last Verified: August 2009

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