Estrogen Receptor-Positive Breast Cancer Patient-Derived Xenografts

Sponsor

Dartmouth-Hitchcock Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02752893

Collaborator

(none)

Enrollment

Location

26.1

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer

Study Design

Study Type:

Observational

Actual Enrollment :

10 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Estrogen Receptor-Positive Breast Cancer Patient-Derived Xenografts

Actual Study Start Date :

Jan 30, 2017

Actual Primary Completion Date :

Apr 3, 2019

Actual Study Completion Date :

Apr 3, 2019

Outcome Measures

Primary Outcome Measures

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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria

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.

Exclusion Criteria