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NCT00516542 · ClinicalTrials.gov registry record · Phase 1

Dehydroepiandrosterone (DHEA) and Letrozole in Treating Patients With Metastatic Breast Cancer

A Phase 1 study, sponsored by OHSU Knight Cancer Institute.

Terminated
Registry status
Phase 1
Development phase
6
Enrollment target

NCT00516542: Clinical Trial Phase 1 study, sponsored by OHSU Knight Cancer Institute.

NCT00516542 is a Phase 1 study that was terminated before completion, run by OHSU Knight Cancer Institute. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00516542, a Phase 1 study, was terminated before completion, sponsored by OHSU Knight Cancer Institute.

TERMINATED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

Study Summary

RATIONALE: Androgens can cause the growth of breast cancer cells. Hormone therapy using dehydroepiandrosterone (DHEA) may fight breast cancer by blocking the use of androgen by the tumor cells. Letrozole may stop the adrenal glands from making androgens. Giving DHEA together with letrozole may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of DHEA when given together with letrozole in treating patients with metastatic breast cancer.

Primary Outcome

Subjects will be monitored at day 14 and then every 2 weeks for up to one year.

Interventions

  • DRUG letrozole
  • DRUG DHEA
  • OTHER pharmacological study

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2007-06
Est. Completion 2010-12
Phase Phase 1
OHSU Knight Cancer Institute

211 total trials

Why NCT00516542 stopped before completion

NCT00516542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 3 interventions - of which letrozole is the first listed.

NCT00516542 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00516542 about?

NCT00516542 is a clinical study titled "Dehydroepiandrosterone (DHEA) and Letrozole in Treating Patients With Metastatic Breast Cancer". RATIONALE: Androgens can cause the growth of breast cancer cells. Hormone therapy using dehydroepiandrosterone (DHEA) may fight breast cancer by blocking the use of androgen by the tumor cells. Letrozole may stop the adrenal glands from making androgens. Giving DHEA together with letrozole may kill ...

What is the current status of trial NCT00516542?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2007-06. Estimated completion is 2010-12.

What interventions are being tested in trial NCT00516542?

The interventions under investigation include: letrozole (DRUG), DHEA (DRUG), pharmacological study (OTHER).

Who is sponsoring clinical trial NCT00516542?

This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00516542's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT00516542, the US trial registry maintained by the National Library of Medicine. NCT00516542 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.