Clinical trial NCT01750164: Patient Derived Breast Cancer Xenografts
Official title: Patient Derived Breast Cancer Xenografts
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with invasive breast cancer with metastatic disease seen in Oncology clinic

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


Eligibility criteria: * Women \> age 18. with a history of ER+. HER-2 negative breast cancer previously treated with adjuvant anti-estrogen therapy (tamoxifen or aromatase inhibitor? for at least 1 year after surgical resection of primary tumor.
* ER+ status requires positive staining in \> 10% of malignant cells in biopsy specimen.
* HER-2 Negative status requires Immunohistochemistry 0-1+, or with a FISH ratio of \< 2.0 if IHC is 2+ or if IHC has not been done.
* Patient must have: A. newly diagnosed recurrent, locally advanced or metastatic breast cancer. B. existing advanced or metastatic breast cancer.
* Patient must be having clinically indicated: A. diagnostic tumor biopsy via core-or needle incision or B. surgical removal of tumor or C. collection of pleural or ascetic fluid in order to obtain fresh tumor tissue for research (transplant into mice).
* For subjects having a diagnostic tumor biopsy, excess fresh tumor tissue must be available from the biopsy for research for immediate transplantation into mice.
* For subjects having a surgical resection of the primary tumor, the tumor must have a clinical size of 1 cm or greater, and and excess fresh tumor tissue must be available from the surgical specimen for research for immediate transplantation into mice.
* Ability to give signed informed consent

Primary outcomes:
measure: Successful Engraftment
timeFrame: 2 years
Secondary outcomes:
measure: Time until tumor formation
timeFrame: 2 years
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Gary Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References: