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-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 253
•Postmenopausal, Hormone-receptor positive breast cancer
• 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 advanced (metastatic or locally advanced) setting.
• Dose expansion:
Arms 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 prior to starting study treatment; Patients who received (neo) adjuvant therapy
for breast cancer are eligible.
•Other protocol-defined inclusion/exclusion criteria may apply - see protocol for additional details
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 152
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 101
•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
•Diffuse lymphangitic carcinomatosis
•Another malignancy within 3 years
•Receiving hormone replacement therapy that cannot be discontinued
•Impaired cardiac function
•Other protocol-defined inclusion/exclusion criteria may apply - see protocol for details
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