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NCT01791478 · ClinicalTrials.gov registry record · Phase 1
BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer
A Phase 1 study of HER2-Negative Breast Cancer and Stage IV Breast Cancer, sponsored by Vanderbilt-Ingram Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 2
- Study locations
NCT01791478: Active Phase 1 study of HER2-Negative Breast Cancer and Stage IV Breast Cancer, sponsored by Vanderbilt-Ingram Cancer Center.
NCT01791478 is a Phase 1 study of HER2-Negative Breast Cancer and Stage IV Breast Cancer that is active but no longer recruiting, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 46 participants, below the 254-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01791478, a Phase 1 study of HER2-Negative Breast Cancer and Stage IV Breast Cancer, is active but no longer recruiting, sponsored by Vanderbilt-Ingram Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of the PI3K inhibitor BYL719 when given together with letrozole in treating patients with hormone receptor-positive metastatic breast cancer. The PI3K inhibitor BYL719 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving the PI3K inhibitor BYL719 together with letrozole may kill more tumor cells
Primary Outcome
Highest dose of BYL719 tested in which a DLT is experienced by 0 out of 3 or 1 of 6 patients, based on the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG letrozole
- DRUG PI3K inhibitor BYL719
- OTHER pharmacological studies
Study Locations (2)
Massachusetts
- Massachusetts General Hospital, Dana-Farber Cancer Institute - Boston
Tennessee
- Vanderbilt-Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2013-04 |
| Est. Completion | 2025-02-28 |
| Phase | Phase 1 |
What the registry record for NCT01791478 still lists
NCT01791478 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 254-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (82% lower).
The record links to 6 conditions, with HER2-Negative Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01791478 reports a single indexed study location in Massachusetts, Tennessee.
Frequently Asked Questions
What is clinical trial NCT01791478 about?
NCT01791478 is a clinical study titled "BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer". This phase I trial studies the side effects and best dose of the PI3K inhibitor BYL719 when given together with letrozole in treating patients with hormone receptor-positive metastatic breast cancer. The PI3K inhibitor BYL719 may stop the growth of tumor cells by blocking some of the proteins needed...
What is the current status of trial NCT01791478?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2013-04. Estimated completion is 2025-02-28.
What conditions does trial NCT01791478 study?
This clinical trial studies the following conditions: HER2-Negative Breast Cancer, Stage IV Breast Cancer, Recurrent Breast Cancer, Estrogen Receptor-positive Breast Cancer, Invasive Ductal Breast Carcinoma.
What interventions are being tested in trial NCT01791478?
The interventions under investigation include: laboratory biomarker analysis (OTHER), letrozole (DRUG), PI3K inhibitor BYL719 (DRUG), pharmacological studies (OTHER).
Who is sponsoring clinical trial NCT01791478?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01791478 being conducted?
This trial has 2 study locations across Massachusetts, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01791478's enrollment target sits among peer trials
46 29th of 49 higher than 21 of 49 other HER2-Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-Negative Breast Cancer 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.
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