Patient Derived Breast Cancer Xenografts

Terminated

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT01750164
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

This study will use tissue or body fluid acquired during standard procedures that are part of the patient's care for their cancer, such as surgery to remove tumor tissue or needle withdrawal of body fluid containing cancer cells. The tissue or cells will be injected into immune compromised mice and the tissue will be allowed to grow to a tumor 1-1.5 cm size. The tissue will then be extracted and either frozen, embedded in paraffin, or used for engraftment into another generation of mice. The second generation mice will be separated into groups and given various treatments.

Tissue from the participants and from the mouse established tumors, in which the mice have either received treatment or have not received treatment, will be used to evaluate the levels of various genes that assist in regulating cell growth and cell death. The tumor tissue from participants and mice will also be tested for random changes in the genetic material and compared to the participant's blood to determine if any of the changes in the genetic material correlate with better engraftment of the patient tissue in the mice. It is anticipated that 10-30% will have successful engraftment of tumor tissue

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-17
• Status Verified: 2013-12
• Study Start: 2013-12
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2015-05-08
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful Engraftment	2 years	Thirty-five patients with breast cancer will be recruited. We anticipate that 10-30% will have successful engraftment of tumor tissue. The achievement of five successful xenografts would justify additional study.

Secondary Outcome Measures

Name	Time	Method
Time until tumor formation	2 years	The rate of tumor growth will be calculated. Mice are monitored three times per week for general health and tumor length. Tumor length Tumor length and width are measured with calipers and recorded. Tumor volume will be calculated with the formula (Length x Width x Width)/2, derived from the formula for the volume of an ellipsoid. Tumor growth will be measured at each time point by calculating the ratio of tumor volume (V) to the initial tumor volume (Vo). Average time, measured in weeks, required for tumors to form palpable masses in F1 mice will be recorded as the Time-until-Tumor-Formation (TTF). A comparison of TTF between tumor cells isolated from tumor tissue isolated by surgical biopsy, and by malignant cells in a body fluid will be compared

Trial Locations

Locations (1)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States