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NCT01105312 · ClinicalTrials.gov registry record · Phase 1
Panobinostat and Letrozole in Treating Patients With Metastatic Breast Cancer
A Phase 1 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01105312: Completed Phase 1 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT01105312 is a Phase 1 study that has completed, run by Alliance for Clinical Trials in Oncology. 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
NCT01105312, a Phase 1 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
RATIONALE: Panobinostat 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 lowering the amount of estrogen the body makes. Giving panobinostat together with letrozole may be an effective treatment for breast cancer. PURPOSE: This phase I/II trial is studying the side effects and best dose of panobinostat when given together with letrozole and to see how well it works in treating patients with metastatic breast cancer.
Primary Outcome
MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6\> new patients). If dose-limiting toxicity (DLT) is not seen in any of the 3 patients, 3 new patients will be accrued and treated at the next higher dose level. If DLT are seen in 2 or 3 of 3 patients treated at a given dose level, then the next 3 patients will be treated at the next lower dose level, if only 3 patients were enrolled and treat
Interventions
- GENETIC microarray analysis
- DRUG panobinostat
- DRUG letrozole
- GENETIC RNA analysis
- GENETIC reverse transcriptase-polymerase chain reaction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-09-03 |
| Phase | Phase 1 |
What the finished NCT01105312 record still lists
NCT01105312 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 microarray analysis is the first listed.
NCT01105312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01105312 about?
NCT01105312 is a clinical study titled "Panobinostat and Letrozole in Treating Patients With Metastatic Breast Cancer". RATIONALE: Panobinostat 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 lowering the amount of estrogen the body makes. Giving panobinostat toge...
What is the current status of trial NCT01105312?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2010-09. Estimated completion is 2013-09-03.
What interventions are being tested in trial NCT01105312?
The interventions under investigation include: microarray analysis (GENETIC), panobinostat (DRUG), letrozole (DRUG), RNA analysis (GENETIC), reverse transcriptase-polymerase chain reaction (GENETIC).
Who is sponsoring clinical trial NCT01105312?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01105312'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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