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NCT00959556 Clinical Trial

Study of Blood Samples in Patients With Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00959556
Other study ID # CDR0000633531
Secondary ID COL-GENEOMCOL-ID
Status Recruiting
Phase N/A
First received August 13, 2009
Last updated January 7, 2011
Start date November 2007

Study information
Verified date August 2009
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Observational

Clinical Trial 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.

Description:

OBJECTIVES:

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 900
Est. completion date
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

N/A

Related Conditions & MeSH terms

Intervention

Other:
• laboratory biomarker analysis

Locations
Country Name City State
France Centre Oscar Lambret Lille

Sponsors (1)
Lead Sponsor Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Histologic complete response (Chevallier and Sataloff) or tumor response (RECIST) No
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