Study of Tumor and Blood Samples From Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Colon and Breast Cancer Diagnostics. Clinical Protocol Associated With Cancer of the Breast.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00897728
• Other study ID #: CDR0000599189
• Secondary ID: CLCC-IC-COBRED-S
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: November 30, 2010
• Start date: February 2008

Study information

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

Clinical Trial Summary

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor and blood samples from women with breast cancer.

Description:

OBJECTIVES:

Primary

• Assess relapse locally or remotely using biomarkers collected from primary tumor and blood samples from women with breast cancer during the first 2 years after diagnosis.

Secondary

• Evaluate all relapses.

• Assess survival without relapse.

• Determine correlation between biomarkers and relapse.

OUTLINE: Primary tumor and blood samples collected during usual care of patients during the first 2 years after diagnosis are analyzed for biomarkers useful in monitoring and diagnosing breast cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of infiltrating unilateral breast cancer

• No in situ disease (ductal or lobular)

• No invasive bilateral synchronous disease

• Breast cancer at high risk, defined by at least 2 of the following factors:

• Hormone receptor negative (HR-)

• Axillary node positive

• Histopathologic grade III

• High mitotic index (as defined by the Curie Institute as > 20 mitoses per 10 high-power fields [HPF])

• Tumor size = 2 cm

• HER2-positive (3 + IHC or FISH/ICHS positive)

• Triple-negative tumors (HR- and HER2-negative)

• Initial thoracic-abdomino-pelvic and bone scans must be negative

• Underwent initial surgery

PATIENT CHARACTERISTICS:

• Menopausal status not specified

• Serum calcium normal (15.3 mg/dL) or normalized within 8 weeks after surgery

• No other invasive cancer within the past 5 years

• Not pregnant or nursing

• No psychological, familial, social, or geographical reasons that make monitoring impossible

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
France	Institut Curie Hopital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local or remote relapse as assessed by biomarkers in tissue and blood samples collected during the first 2 years after diagnosis			No