Patient Derived Breast Cancer Xenografts

This study is currently recruiting participants.
Verified December 2013 by Dartmouth-Hitchcock Medical Center
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01750164
First received: December 12, 2012
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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


Condition
Metastatic Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Patient Derived Breast Cancer Xenografts

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Successful Engraftment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Time until tumor formation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples With DNA

whole blood and tumor tissue samples as well as DNA that has been extracted from both blood and tiisue will be stored.


Estimated Enrollment: 35
Study Start Date: December 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Invasive breast cancer with metastatic disease

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with invasive breast cancer with metastatic disease seen in Oncology clinic

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750164

Contacts
Contact: Gary Schwartz, MD 800-639-6918 Cancer.Research.Nurse@Dartmouth.edu

Locations
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Gary Schwartz, MD    800-639-6918    Cancer.Research.Nurse@Dartmouth.edu   
Principal Investigator: Gary Schwartz, MD         
Sub-Investigator: Todd Miller, PhD         
Sub-Investigator: Kari Rosenkranz, MD         
Sub-Investigator: Johnathan Marotti, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Gary Schwartz, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01750164     History of Changes
Other Study ID Numbers: D12168
Study First Received: December 12, 2012
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014