Clinical trial · Interventional
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.
NCT02154776CI-TRIAL-00049006LeeBLetcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multi-center, open-label, non-randomized, phase I study
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Buparlisib | Drug | Buparlisib | ALIAS |
| LEE011 | Drug | Ribociclib | ALIAS |
| Letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LEE011 + buparlisib + letrozole
- description
- open label, dose escalation evaluating max tolerated dose of the triple combination
- interventionNames
- Drug: LEE011
- Drug: Buparlisib
- Drug: Letrozole
Primary outcomes (2)
- measure
- Incidence of dose-limiting toxicities (DLTs)
- timeFrame
- 28 days
- description
- Dose Escalation Phase: Frequency of DLTs at each dose level associated with administration of LEE011, buparlisib, and letrozole in a 28 day cycle
- measure
- Safety and tolerability of the combination of LEE011, buparlisib, and letrozole
- timeFrame
- approximately 25 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women with advanced (recurrent or metastatic) breast cancer who received no prior therapy for advanced disease. 2. Patient is postmenopausal. 3. Patient may have received ≤ 2 lines of chemotherapy for metastatic or recurrent breast cancer in the dose-escalation phase. 4. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory. 5. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing. 6. Patient must have either: * Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria or at least one predominantly lytic bone lesion Exclusion Criteria: 1. Patient who received any CDK4/6 or PI3K inhibitor. 2. Patient has active cardiac disease or a history of cardiac dysfunction including any of the following: * History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry * History of documented congestive heart failure (New York Heart Association functional classification III-IV) * Documented cardiomyopathy * Patient has a Left Ventricular Ejection Fraction (LVEF) \< 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) * History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months. * On screening, any of the following cardiac parameters: bradycardia (heart rate \< 50 at rest), tachycardia (heart rate \> 90 at rest), PR interval \> 220 msec, QRS interval \>109 msec, or QTcF \>450 msec. Systolic blood pressure \>160 or \<90 mmHg 3. Patient is currently receiving any of the following medications: * That are known strong inducers or inhibitors of CYP3A4. * That have a known risk to prolong the QT interval or induce Torsades de Pointes. * That have a narrow therapeutic window and are predominantly metabolized through CYP3A4. 4. Certain scores on an anxiety and depression mood questionnaires
References
Publications (0)
Data not yet available
No reference posted for this study.