A phase Ib/II, multicenter, study of the combination of LEE011 and BYL719 with letrozole in adult patients with advanced ER+ breast cancer
Key facts
- Where
- Madrid és Sevilla, SpanyolországSee the 3 sites
- Phase
- 1/2. fázis
Where in Spanyolország
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországNo longer taking part
- Hospital Universitario HM SanchinarroMadrid, SpanyolországNo longer taking part
- University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharma AG
- Trial code
- EU 2023-509511-84-00
- Record updated
- 2026. szeptember 25.
- Original description
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).Read full original descriptionShow less
A Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer
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
Inclusion: 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.
Exclusion: 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; Another malignancy within 3 years; Impaired cardiac function; 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; Acute or chronic pancreatitis; Bilateral diffuse lymphangitic carcinomatosis.