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NCT01870505 · ClinicalTrials.gov registry record · Phase 1
BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT01870505: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01870505 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01870505, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety of a drug called BYL719 at different dose levels. The investigators want to find out what effects, good and/or bad, BYL719 has on the patient and breast cancer. BYL719 will be given with either letrozole or exemestane to patients with HR+ locally-advanced or metastatic breast cancer. When the recommended phase II dose of BYL719 in combination with letrozole or exemestane has been determined in the dose-finding phase, an additional 10 patients will be enrolled onto each arm in an expansion phase of the study. The purpose of the expansion phase is to further define the safety and feasibility of BYL719 in combination with letrozole or exemestane at the recommended phase II dose, and to estimate efficacy.
Primary Outcome
Participants started BYL719 dose of 300mg daily for cohort 0. Consecutive cohorts were administered increasing or decreasing dose levels of BYL719. All participants within a cohort will be observed for toxicity for one cycle (28 days) prior to entering additional patients.
Interventions
- DRUG Letrozole
- DRUG Exemestane
- DRUG BYL719
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2013-05 |
| Est. Completion | 2022-02-28 |
| Phase | Phase 1 |
What the finished NCT01870505 record still lists
NCT01870505 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 3 interventions - of which Letrozole is the first listed.
NCT01870505 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01870505 about?
NCT01870505 is a clinical study titled "BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer". The purpose of this study is to test the safety of a drug called BYL719 at different dose levels. The investigators want to find out what effects, good and/or bad, BYL719 has on the patient and breast cancer. BYL719 will be given with either letrozole or exemestane to patients with HR+ locally-advan...
What is the current status of trial NCT01870505?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2013-05. Estimated completion is 2022-02-28.
What interventions are being tested in trial NCT01870505?
The interventions under investigation include: Letrozole (DRUG), Exemestane (DRUG), BYL719 (DRUG).
Who is sponsoring clinical trial NCT01870505?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01870505's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 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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