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NCT02010021 · ClinicalTrials.gov registry record · NA

Presurgical Treatment With Letrozole in Patients With Early-stage Breast Cancer.

A NA study, sponsored by Dartmouth-Hitchcock Medical Center.

Completed
Registry status
NA
Development phase
17
Enrollment target

NCT02010021 is a NA study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 17 participants.

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The verdict

NCT02010021, a NA study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.

COMPLETED
Registry status
NA
Development phase
17 participants
Enrollment target

Study Summary

Some tumors use estrogen in the body to assist with growth. Letrozole is a drug that is prevents cells from producing estrogens. This should assist with the slowing of growth of tumor cells. Letrozole also promotes cell destruction by inhibiting a cellular destruction pathway. The objectives of this study will look at the differences between the cellular destruction pathway before and after letrozole use, and the differences in the cellular destruction pathway in participants that have received letrozole versus those who did not. The study will also look at a gene in all participants called Ki67. This gene is associated with the rate of tumor cell growth. The study will measure the levels of Ki67 and compare them to the amount of activation of the cellular destruction pathway. Participants in this study will have undergone a diagnostic biopsy of their breast tissue. In order to meet these objectives, one group of participants (Arm A) will not receive letrozole. Tissue leftover from their diagnostic biopsy will be treated with everolimus (RAD001) in the laboratory and the effects of this drug on the cellular destruction pathway will be studied. The other group of participants (Arm B) will take letrozole for a minimum of 10 and maximum of 21 days. They will have a second tumor sample taken as part of their surgical procedure completed to remove the tumor tissue. Any differences in the cellular destruction pathway before and after exposure to letrozole will be measured.

Interventions

  • DRUG Letrozole

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2014-01
Est. Completion 2017-12-08
Phase NA

Sponsor

Dartmouth-Hitchcock Medical Center

427 total trials

What the Registry Record Tells You About NCT02010021

The ClinicalTrials.gov registry entry for NCT02010021 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Letrozole is the first listed.

NCT02010021 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02010021 about?

NCT02010021 is a clinical study titled "Presurgical Treatment With Letrozole in Patients With Early-stage Breast Cancer.". Some tumors use estrogen in the body to assist with growth. Letrozole is a drug that is prevents cells from producing estrogens. This should assist with the slowing of growth of tumor cells. Letrozole also promotes cell destruction by inhibiting a cellular destruction pathway. The objectives of thi...

What is the current status of trial NCT02010021?

This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2014-01. Estimated completion is 2017-12-08.

What interventions are being tested in trial NCT02010021?

The interventions under investigation include: Letrozole (DRUG).

Who is sponsoring clinical trial NCT02010021?

This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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