Trial Information
Patient Derived Breast Cancer Xenografts
Inclusion Criteria
- Histologic documentation of invasive breast cancer by core needle or incisional
biopsy
- Cytologic documentation of metastatic disease within a body cavity, for subjects
having therapeutic removal of pleural or ascitic fluid.
- Intent to perform surgical resection of the primary tumor, or therapeutic removal of
pleural or ascitic fluid.
- Women > age 18.
- For subjects having a surgical resection of the primary tumor, the tumor must have a
clinical size of 1 cm or greater, and must not have a lobular histology on the
diagnostic biopsy.
- Ability to give signed informed consent
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Successful Engraftment
Outcome Description:
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.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Gary Schwartz, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dartmouth-Hitchcock Medical Center
Authority:
United States: Institutional Review Board
Study ID:
D12168
NCT ID:
NCT01750164
Start Date:
October 2012
Completion Date:
Related Keywords:
- Metastatic Breast Cancer
- Breast Cancer
- Breast Neoplasms
Name | Location |
Dartmouth Hitchcock Medical Center |
Lebanon, New Hampshire 03756 |