A study of a combination of LEE011 and BYL719 with letrozole in patients with advanced breast cancer
- Conditions
- advanced ER+ breast cancerMedDRA version: 16.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-001219-57-IT
- Lead Sponsor
- OVARTIS FARMA S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 277
•Postmenopausal, Estrogen-receptor positive breast cancer
•Phase Ib dose escalation only: Any number of prior lines of endocrine
therapy is allowed with the exception of cytotoxic therapy which is
limited to one prior line administered in the metastatic or locally
advanced setting.
•Phase Ib dose expansion in Arms 1 and 2 and Phase II: No prior
systemic treatment in the metastatic setting.
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 192
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85
•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