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NCT00376688 · ClinicalTrials.gov registry record · Phase 2

Temsirolimus in Treating Patients With Locally Advanced or Metastatic Breast Cancer

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
31
Enrollment target

NCT00376688: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00376688 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00376688, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
31 participants
Enrollment target

Study Summary

This phase II trial studies how well temsirolimus works in treating patients with breast cancer that has spread to other places in the body. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Primary Outcome

Response evaluation criteria in solid tumors (RECIST) criteria version 1.0 was used for response evaluation. Clinical benefit rate is defined as the proportion of subjects experiencing a complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks. Evaluation of target lesions: Complete Response (CR)-- Disappearance of all target lesions; Partial Response (PR)-- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Temsirolimus

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2006-07-11
Est. Completion 2019-12-16
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00376688 record still lists

NCT00376688 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT00376688 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00376688 about?

NCT00376688 is a clinical study titled "Temsirolimus in Treating Patients With Locally Advanced or Metastatic Breast Cancer". This phase II trial studies how well temsirolimus works in treating patients with breast cancer that has spread to other places in the body. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

What is the current status of trial NCT00376688?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2006-07-11. Estimated completion is 2019-12-16.

What interventions are being tested in trial NCT00376688?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Temsirolimus (DRUG).

Who is sponsoring clinical trial NCT00376688?

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 NCT00376688's enrollment target sits among peer trials

31 1578th of 2000 higher than 419 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00376688, the US trial registry maintained by the National Library of Medicine. NCT00376688 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.