2023-509511-84-00Active, not recruitingPhase 1/2
A phase Ib/II, multicenter, study of the combination of LEE011 and BYL719 with letrozole in adult patients with advanced ER+ breast cancer
A Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Sept 2026
Brief summary (registry, in English)
Dose Escalation: To estimate the MTD and/or RP2D of the following three combinations in patients with HR+/HER2- advanced breast cancer: 1. LEE011 and standard dose letrozole (doublet, Arm 1 escalation) 2. BYL719 and standard dose letrozole (doublet, Arm 2 Cohort 1 escalation) 3. LEE011 3 weeks on/ 1 week off, BYL719 and standard dose letrozole QD (triplet, Arm 3 escalation) Dose Expansion: To characterize the safety and tolerability of LEE011 in combination with letrozole (Arm 1 expansion cohorts), BYL719 in combination with letrozole including both BYL719 morning dosing (Arm 2 Cohort 1 expansion) and BYL719 evening dosing regimens (Arm 2 Cohort 2 expansion), and the triple combination of LEE011 + BYL719 with letrozole (Arms 3 expansion). To characterize the PK profiles of LEE011 (FCT formulation) and letrozole when used in combination
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 83 (estimated)
- First submitted
- 9 Apr 2024
- Start date
- 19 Mar 2014
- Lead sponsor
- Novartis Pharma AG
- Diseases
- Metastatic breast cancer
- EU CT number
- 2023-509511-84-00
- EudraCT number
- 2013-001219-57
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 83
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with active CNS or other brain metastases. Patients with asymptomatic brain metastases that have been adequately treated and do not require corticosteroid therapy and /or enzyme inducing anti–epileptic medication for brain metastases are eligible.
- Major surgery within 2 weeks
- Receiving hormone replacement therapy that cannot be discontinued
Other illness
- Another malignancy within 3 years
- Impaired cardiac function
Lab values
- HER2-overexpression in the patient’s tumor tissue by local laboratory testing (IHC 3+ or in situ hybridization positive).
- Patients with clinically manifest diabetes mellitus (treated and/or clinical signs or with fasting glucose ≥ 126 mg/dL / 7.0 mmol/L or hemoglobin A1c >6.5%), history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus.
Other
- Acute or chronic pancreatitis
- Bilateral diffuse lymphangitic carcinomatosis
Who the study is looking for
- Adult women (age ≥18 years) with advanced (metastatic or locally advanced) breast cancer not amenable to curative treatment by surgery or radiotherapy.
- Histologic or cytologic confirmation of hormone-receptor positive (ER+ and/or PR+) breast cancer
- Postmenopausal women
- Dose Escalation: Any number of prior lines of endocrine therapy is allowed with up to one prior cytotoxic regimen in the advanced (metastatic or locally advanced) setting.
- Dose Expansion Arm 1, 2 and 3: No prior systemic treatment in the advanced (metastatic or locally advanced) setting with the exception of treatment with letrozole or anastrozole for a maximum duration of one month.
- Dose Expansion Arms 2 and 3 and Dose Escalation Arm 4: Patient has known PIK3CA status (mutated or non-mutated)
- Dose Escalation: Presence of measurable or non-measurable disease (as defined by RECIST 1.1 criteria).
- Dose Expansion: At least one measurable lesion, or lytic or mixed bone lesions in the absence of measurable disease (as defined by RECIST 1.1) for Arm 1 to Arm 3
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario HM Sanchinarro | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Active, not recruiting |
| Institut Paoli-Calmettes | Marseille | France | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.