- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00959556
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Contacts and Locations
Study Locations
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Lille, France, 59020
- Centre Oscar Lambret
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Histologic complete response (Chevallier and Sataloff) or tumor response (RECIST)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jacques Bonneterre, MD, PhD, Centre Oscar Lambret
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000633531
- 2007-08 (Other Identifier: Centre Oscar Lambret)
- COL-GENEOM (Other Identifier: Centre Oscar Lambret)
- 2007-A00908-45 (Other Identifier: IDRCB)
- RECF0635 (Registry Identifier: INCa)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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