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NCT00001504 · ClinicalTrials.gov registry record · Phase 1

A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT00001504: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT00001504 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00001504, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

This is a dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic acid given in combination with tamoxifen. Groups of 3 to 6 patients receive oral 9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the regimen. Patients continue treatment for up to 28 weeks, with tamoxifen continued after the study if medically appropriate.

Interventions

  • DRUG 9-cis-Retinoic Acid

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 1996-05
Est. Completion 2002-01
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00001504 record still lists

NCT00001504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 1 intervention - of which 9-cis-Retinoic Acid is the first listed.

NCT00001504 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001504 about?

NCT00001504 is a clinical study titled "A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients". This is a dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic acid given in combination with tamoxifen. Groups of 3 to 6 patients receive oral 9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the regimen. Patients continue treatment for...

What is the current status of trial NCT00001504?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 1996-05. Estimated completion is 2002-01.

What interventions are being tested in trial NCT00001504?

The interventions under investigation include: 9-cis-Retinoic Acid (DRUG).

Who is sponsoring clinical trial NCT00001504?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00001504's enrollment target sits among peer trials

18 1720th of 2000 higher than 216 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 NCT00001504, the US trial registry maintained by the National Library of Medicine. NCT00001504 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.