Developing Mouse Models of Breast Cancer Using Tissue Samples From Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Developing In-Vivo Models of Human Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897468
• Other study ID #: VICC BRE 0704
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Start date: February 2007
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Changing the genes in laboratory mice to create a living model of human breast cancer may help doctors learn more about breast cancer.

PURPOSE: This research study is developing mouse models of breast cancer using tissue samples that were previously collected from women with breast cancer.

Description:

OBJECTIVES:

• To develop new in vivo models of human breast cancer.

• To correlate response in this model to actual treatment outcome in patients, if the in vivo model is proven feasible.

OUTLINE: Previously collected breast tumor fragments are implanted into the renal capsule site of SCID mouse hosts (mouse with severe combined immune deficiency) to establish metastatic spread patterns, and both histologic and molecular tumor characteristics.

Patients' medical charts are reviewed to obtain relevant information, including general demographics, smoking and alcohol use, as well as outcome data such as survival and response to treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of breast cancer

• Any stage of disease

• Primary or metastatic disease

• Human breast tumor tissues available after the diagnoses have been made

• Enrolled on the ongoing Breast Tissue Repository trial VU-VICC-BRE-03103

• Have consented to the use of their tissues for research purpose

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• laboratory biomarker analysis
Tissue samples will either be collected at the time of medically indicated surgical procedures or through research core biopsies. A sample of urine will also be obtained. Blood will be collected via venipuncture and lymphocytes (mononuclear cells) separated and processed as a source of normal DNA and normal cells.
• medical chart review
patient chart review will occur in conjunction with patient data collection for final analyses.

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of new in vivo models of human breast cancer		1 year
Primary	Correlation of response in this model to actual treatment outcome in patients, if the in vivo model proven feasible		5 years

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial