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Study of Blood Samples in Patients With Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Locations
France
Study Type
Observational
Intervention
laboratory biomarker analysis
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Oscar LambretRecruiting

Outcomes

Primary Outcome Measures

Histologic complete response (Chevallier and Sataloff) or tumor response (RECIST)

Secondary Outcome Measures

Full Information

First Posted
August 13, 2009
Last Updated
January 7, 2011
Sponsor
Centre Oscar Lambret
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1. Study Identification

Unique Protocol Identification Number
NCT00959556
Brief Title
Study of Blood Samples in Patients With Breast Cancer
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 Type
Observational

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Oscar Lambret

4. Oversight

5. 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.
Detailed Description
OBJECTIVES: Identify constitutional gene variants associated with a change in response. OUTLINE: Blood samples are collected periodically for analysis of genetic factors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
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

7. Study Design

Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Histologic complete response (Chevallier and Sataloff) or tumor response (RECIST)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Bonneterre, MD, PhD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Bonneterre, MD, PhD
Phone
33-3-20-29-5959
Email
j.bonneterre@o-lambret.fr

12. IPD Sharing Statement

Learn more about this trial

Study of Blood Samples in Patients With Breast Cancer

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