Estrogen Receptor-Positive Breast Cancer Patient-Derived Xenografts

NCT02752893 | Completed DMC

• 1 other identifier: D16100
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will establish a platform at Dartmouth-Hitchcock Medical Center to generate novel models of estrogen receptor alpha-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, which will be used for research studies to develop novel treatment strategies and dissect signaling pathways underlying drug sensitivity and resistance.

Conditions

Breast Cancer

Keywords

estrogen; estrogen receptor; ER+; HER2; HER2-; HER2-negative; xenograft; co-clinical; mice; patient-derived xenograft; patient-derived; breast cancer; precision medicine; personalized medicine

Outcome Measures

Primary Outcomes (1)

• Xenograft success rate, defined as the percentage of patient tumors that yield a growing xenograft in mice.

  1 year from time of surgery

Eligibility Criteria

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

Study Population

Subjects \>18 years of age with disease progression during neoadjuvant therapy, recurrence after neoadjuvant or adjuvant therapy, or progression after systemic therapy for metastatic disease that expresses estrogen receptor alpha (ER+) and does not overexpress HER2 (HER2-, HER2-negative). Subjects must be scheduled to undergo a clinically indicated biopsy or surgical removal of tumor, and excess tumor tissue must be available for research use.

You may qualify if:

• Men and women \> age 18 with histologically documented ER+/HER2- breast cancer or with a history of ER+/HER2- breast cancer, for whom a tumor biopsy or surgical resection is clinically indicated and will be performed as standard of care.
• Tumor specimens may be from breast (progressive or recurrent) or metastatic sites. Patients with multicentric or bilateral disease are eligible.
• Patients must have disease progression during neoadjuvant therapy, recurrence after neoadjuvant or adjuvant therapy, or progression after systemic therapy for metastatic disease.
• ER positivity is defined as \>10% of malignant tumor cells staining positively for ER by immunohistochemistry (IHC).
• HER2 negativity is defined as IHC 0-1+, or with a fluorescence in situ hybridization (FISH) ratio of \<1.8 if IHC is 2+ or if IHC has not been done.
• Excess LIVE tumor tissue must be available from the surgically resected tumor specimen, or from 1-3 extra core needle or incisional biopsy. LIVE tumor tissue must be available within 2 hours of removal from patient (shorter time is preferable).
• A recurrent or progressing breast cancer must be greater than 1 cm in greatest diameter.
• Prior therapy is allowed as long as excess viable tumor tissue is available from the biopsy or surgical excision procedure.
• Patients must be willing to provide 6 mL of blood, which can be obtained during a routine clinically indicated blood draw (ideally, done on the same day as the tumor biopsy/surgery).
• Ability to give signed informed consent.

You may not qualify if:

• \. Fine needle aspirates and effusions of bodily fluids are not eligible as sources of tumor cells.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Hematology-Oncology

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: April 27, 2016
• Study Start: January 30, 2017
• Primary Completion: April 3, 2019
• Study Completion: April 3, 2019
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)