NCT02752893

Completed

Estrogen Receptor-Positive Breast Cancer Patient-Derived Xen...

Dartmouth-Hitchcock Medical Center Source

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Other study identifiers

Sponsor study identifier

D16100

Study Type

observational

Actual enrollment (reported)

10

Locations

1 country

Sites

1

Timeline

Study Start

January 30, 2017

Actual (reported)

Primary Completion

April 3, 2019

Actual (reported)

Study Completion

April 3, 2019

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 10 participants
Study completion date: April 3, 2019
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 26, 2016
Actual (reported)
First Posted
April 27, 2016
Actual (reported)
Study Start
January 30, 2017
Actual (reported)
Primary Completion
April 3, 2019
Actual (reported)
Study Completion
April 3, 2019
Actual (reported)

Last Updated: June 1, 2020
Status Verified: May 2020
Last Update Submitted: May 29, 2020

Conditions

Breast Cancer

Keywords

estrogenestrogen receptorER+HER2HER2-HER2-negativexenograftco-clinicalmicepatient-derived xenograftpatient-derivedbreast cancerprecision medicinepersonalized 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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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:

Sponsors & Collaborators

Dartmouth-Hitchcock Medical Center
Otherlead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Enrollment

10 participants (actual enrollment reported by the registry).

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

Actual (reported)

NCT03078751

Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer

Phase 2Completed

NCT02659514

Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer

Phase 2Completed

NCT03573804

The Prone to Supine Breast MRI Trial

Not ApplicableCompleted

NCT02999477

A Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer

Phase 1Completed

NCT02291913

Everolimus Combined With Anti-estrogen Therapy in Hormone-Receptor-Positive HER-2 Negative Advanced Breast Cancer

Phase 2Completed

NCT03587740

ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer

Phase 2Active Not Recruiting

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.

Contact the study team to confirm eligibility.

Primary Completion

April 3, 2019

Actual (reported)

Study Completion

April 3, 2019

Actual (reported)

Last Updated

June 1, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02752893
Data provider: ClinicalTrials.gov
Source updated: 2020-06-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:59 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations