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NCT01208441 · ClinicalTrials.gov registry record · Phase 1
RO4929097 and Letrozole in Treating Post-Menopausal Women With Hormone Receptor-Positive Stage II or Stage III Breast Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01208441: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01208441 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01208441, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This phase I trial is studying the side effects and best dose of RO4929097 when given together with letrozole in treating post-menopausal women with stage II or stage III breast cancer. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving RO4929097 together with letrozole may be an effective treatment for breast cancer.
Interventions
- DRUG letrozole
- PROCEDURE therapeutic conventional surgery
- OTHER diagnostic laboratory biomarker analysis
- DRUG gamma-secretase/Notch signalling pathway inhibitor RO4929097
- PROCEDURE breast biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2010-11 |
| Phase | Phase 1 |
Why NCT01208441 stopped before completion
NCT01208441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 5 interventions - of which letrozole is the first listed.
NCT01208441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01208441 about?
NCT01208441 is a clinical study titled "RO4929097 and Letrozole in Treating Post-Menopausal Women With Hormone Receptor-Positive Stage II or Stage III Breast Cancer". This phase I trial is studying the side effects and best dose of RO4929097 when given together with letrozole in treating post-menopausal women with stage II or stage III breast cancer. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can ...
What is the current status of trial NCT01208441?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2010-11.
What interventions are being tested in trial NCT01208441?
The interventions under investigation include: letrozole (DRUG), therapeutic conventional surgery (PROCEDURE), diagnostic laboratory biomarker analysis (OTHER), gamma-secretase/Notch signalling pathway inhibitor RO4929097 (DRUG), breast biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT01208441?
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 NCT01208441's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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