Patient Derived Breast Cancer Xenografts
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2014 |
| Start Date: | December 2013 |
| Contact: | Gary Schwartz, MD |
| Email: | Cancer.Research.Nurse@Dartmouth.edu |
| Phone: | 800-639-6918 |
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
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
- 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
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