Trials / Completed
CompletedNCT02154776
Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.
A Phase 1 Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole for the Treatment of HR+, HER2-negative Post-menopausal Women With Locally Advanced or Metastatic Breast Cancer.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, open-label, non-randomized, phase I study
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LEE011 | 3 weeks on and 1 week off |
| DRUG | Buparlisib | daily |
| DRUG | Letrozole | 2.5 mg daily; |
Timeline
- Start date
- 2014-06-27
- Primary completion
- 2016-10-26
- Completion
- 2016-10-26
- First posted
- 2014-06-03
- Last updated
- 2020-12-19
Locations
6 sites across 2 countries: United States, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02154776. Inclusion in this directory is not an endorsement.