Patient Derived Breast Cancer Xenografts

NCT01750164 | Terminated DMC

• 1 other identifier: D12168
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Metastatic Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Successful Engraftment

  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.

  2 years

Secondary Outcomes (1)

• Time until tumor formation

  2 years

Study Arms (1)

Invasive breast cancer with metastatic disease

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gary Schwartz, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 17, 2012
• Study Start: December 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 12, 2015

Record last verified: 2013-12

Locations

US (1)