A study of everolimus plus exemestane versus everolimus versus capecitabine in postmenopausal women with ER+ ABC after recurrence or progression on non-steroidal aromatase inhibitor (NSAI)
- Conditions
- Estrogen receptor positive locally advanced or metastatic breast cancer in postmenopausal womenMedDRA version: 20.0 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003757-28-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 309
-Women with locally advanced, recurrent, or metastatic breast cancer along with confirmation of estrogen-receptor positive (ER+).
- Measurable disease defined as at least one lesion = 10 mm by CT or MRI that can be accurately measured in at least one dimension (CT scan slice thickness = 5 mm) OR • Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.
Other protocol-defined inclusion criteria may apply
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 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
-Patients who received more than one chemotherapy line.
-Patients with only non-measurable lesions other than lytic or mixed (lytic and blastic) bone metastasis.
- Previous treatment with exemestane, mTOR inhibitors, PI3K inhibitors or AKT inhibitors.
Other protocol-defined 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