A study of a combination of LEE011 and BYL719 with letrozole in patients with advanced breast cancer
- Conditions
- advanced ER+ breast cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-001219-57-ES
- Lead Sponsor
- ovartis Farmacéutica, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 97
?Postmenopausal, Estrogen-receptor positive breast cancer
?Phase Ib Parts 1A and 2A Expansion and Phase II only: No prior systemic treatment in the metastatic setting.
?Phase Ib Parts 1, 2 and 3 Dose Escalation only: Any number of prior lines of endocrine therapy is allowed with up to one prior cytotoxic regimen in the metastatic or locally advanced setting
EXPANSIÓN DE DOSIS DE LA FASE IB EN EL BRAZO 1 Y 2 Y FASE II: NINGÚN TRATAMIENTO PREVIO SISTÉMICO EN EL MARCO METASTÁSICO1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65
?HER2-overexpression in the patient's tumor tissue
?Patients with active CNS or other brain metastases
?Major surgery within 2 weeks
?Acute or chronic pancreatitis
?Bilateral diffuse lymphangitic carcinomatosis
?Another malignancy within 3 years
?Receiving hormone replacement therapy that cannot be discontinued
?Impaired cardiac function
?Patients with clinically manifest diabetes mellitus (treated and/or clinical signs or with fasting glucose ? 140 mg/dL / 7.8 mmol/L), history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus.
?Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method