Study of Blood Samples in Patients With Breast Cancer | NCT00959556

Studies
Study of Blood Samples in Patients With Breast Cancer

NCT00959556

Sponsor

Centre Oscar Lambret

Status

Completed

Last Update Posted

Mar 18, 2026Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Breast Cancer

Interventions

laboratory biomarker analysis

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
COL-GENEOM	Other Identifier	Centre Oscar Lambret
2007-A00908-45	Other Identifier	IDRCB
2007-08	Other Identifier	Centre Oscar Lambret
RECF0635	Registry Identifier	INCa

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 28, 2007Actual

Primary Completion Date

Jan 6, 2012Actual

Completion Date

Jan 6, 2012Actual

First Submitted Date

Aug 13, 2009

First Submission Date that Met QC Criteria

Aug 13, 2009

First Posted Date

Aug 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
laboratory biomarker analysis	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Histologic complete response (Chevallier and Sataloff) or tumor response (RECIST)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacques Bonneterre, MD, PhD	Centre Oscar Lambret	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Oscar Lambret		Lille		59020	France

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided