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NCT00082810 · ClinicalTrials.gov registry record · Phase 2
Tipifarnib and Fulvestrant in Hormone Receptor-Positive Metastatic Breast Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT00082810: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00082810 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 33 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00082810, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study Summary
This phase II trial is studying how well giving tipifarnib together with fulvestrant works as second-line therapy in treating postmenopausal women with hormone receptor-positive inoperable locally advanced or metastatic breast cancer that has progressed after previous first-line endocrine therapy. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen. Combining tipifarnib with fulvestrant may kill tumor cells that did not respond to first-line therapy.
Primary Outcome
Number of participants met the definition of Clinical Benefit Rate.Tumor response was assessed every three cycles by CT using RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease
Interventions
- DRUG fulvestrant
- DRUG tipifarnib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2004-03 |
| Est. Completion | 2008-09 |
| Phase | Phase 2 |
What the finished NCT00082810 record still lists
NCT00082810 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which fulvestrant is the first listed.
NCT00082810 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00082810 about?
NCT00082810 is a clinical study titled "Tipifarnib and Fulvestrant in Hormone Receptor-Positive Metastatic Breast Cancer". This phase II trial is studying how well giving tipifarnib together with fulvestrant works as second-line therapy in treating postmenopausal women with hormone receptor-positive inoperable locally advanced or metastatic breast cancer that has progressed after previous first-line endocrine therapy. T...
What is the current status of trial NCT00082810?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2004-03. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00082810?
The interventions under investigation include: fulvestrant (DRUG), tipifarnib (DRUG).
Who is sponsoring clinical trial NCT00082810?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00082810's enrollment target sits among peer trials
33 1553rd of 2000 higher than 438 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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