Estrogen Receptor-Positive Breast Cancer Patient-Derived Xenografts

May 29, 2020 updated by: Gary Schwartz, Dartmouth-Hitchcock Medical Center
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion criteria

  1. 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.

  2. Patients must have disease progression during neoadjuvant therapy, recurrence after neoadjuvant or adjuvant therapy, or progression after systemic therapy for metastatic disease.

  3. 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.

  4. 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).
  5. A recurrent or progressing breast cancer must be greater than 1 cm in greatest diameter.
  6. Prior therapy is allowed as long as excess viable tumor tissue is available from the biopsy or surgical excision procedure.
  7. 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).
  8. Ability to give signed informed consent.

Exclusion Criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Xenograft success rate, defined as the percentage of patient tumors that yield a growing xenograft in mice.
Time Frame: 1 year from time of surgery
1 year from time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2017

Primary Completion (Actual)

April 3, 2019

Study Completion (Actual)

April 3, 2019

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Actual)

June 1, 2020

Last Update Submitted That Met QC Criteria

May 29, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D16100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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