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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: Completed NA study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT02010021 is a NA study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Primary Endpoint is to determine the effect of ex vivo mTORC1 inhibition with everolimus (RAD001) on IRS-1/PI3K/AKT pathway activation (as measured by phospho-AKT-T308 and phospho-AKT-S473) in ER+/human epidermal growth factor receptor 2 (HER2)- breast tumors treated with presurgical letrozole compared to ER+/HER2- breast tumors not treated with presurgical therapy.
Interventions
- DRUG Letrozole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2014-01 |
| Est. Completion | 2017-12-08 |
| Phase | NA |
What the finished NCT02010021 record still lists
NCT02010021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Letrozole is the first listed.
NCT02010021 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02010021's enrollment target sits among peer trials
17 1871st of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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