Metastatic breast cancer MedDRA version: 20.0 Level: LLT Classification code 10006285 Term: Breast neoplasm NOS System Organ Class: 100000004864
Conditions
Interventions
Product Name: Selumetinib
Product Code: [AZD6244]
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: selumetinib sulfate
Current Sponsor code: AZD6244
Other descriptive name: selumetinib sulfate
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Screening 1. Provision of signed, written and dated informed consent for genetic research. 2. Patients with histologically confirmed breast adenocarcinoma. 3. Patient has radiologic evidence of inoperable locally advanced, or metastatic BC 4. Presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample collected no longer than 6 months earlier. 5. Presence of measurable target lesion according to RECIST criteria v1.1. 6. Age > 18 years and 50% and shortening fraction [SF] >15%). PATIENT RANDOMIZATION IN THE THERAPEUTIC PHASE Inclusion criteria: 1) Patients who still meet the screening phase inclusion criteria 2) Patients will have had a minimum of 21 days gap from last chemotherapy or biological therapy administration prior to therapy modification. 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Patients with known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, has been treated with surgery and / or radiation, and has been stable without requiring corticosteroids nor anti-convulsant medications for at least 2 weeks prior to the first dose of study medication. 2. History of clinically significant or uncontrolled cardiac disease, including angina, coronary artery bypass graft, angioplasty, vascular stent , myocardial infarction, atrial fibrillation within 6 months or history of ventricular arrhythmia, Congestive Cardiac Failure (CCF) or Ischaemic Heart Disease (IHD) with no limit of time (New York Heart Association [NYHA] functional classification = 3. Uncontrolled arterial hypertension (defined as systolic blood pressure = 140mmHg and/or diastolic blood pressure = 90mmHg with optimized antihypertensive therapy or patient treated with more than 2 antihypertensive agents) or systolic blood pressure = 160mmHg and/or diastolic blood pressure = 100mmHg : 4. Participation in another clinical study with an investigational product (IP) during the last 30 days. 5. Bone metastases as the only site of biopsiable disease 6. Previous treatment with the study drugs or drugs of this class (e.g. Everolimus) PATIENT RANDOMIZATION IN THE THERAPEUTIC PHASE 1) Patients who still meet the screening phase exclusion criteria 2) Residual toxicities of grade > 2 from previous treatments, with the exception of alopecia. 3) Major surgery within 30 days prior to entry into the study (excluding placement of vascular access or minor surgery within 14 days of entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare progression-free-survival in the experimental group compared to standard chemotherapy;Secondary Objective: -To compare overall survival -To compare response rates -To evaluate safety of the strategy as a whole -To explore the efficacy (response rate, progression-free survival, overall survival) of the individual targeted agents. -To correlate molecular mechanisms in patients with the efficacy endpoints (response rate, progression-free and overall survival) -To investigate the additional molecular mechanisms in patients with tumor response versus patients without tumor response. ;Primary end point(s): progression free-survival;Timepoint(s) of evaluation of this end point: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival ;Timepoint(s) of evaluation of this end point: 36 months | — |
Countries
Italy
Contacts
Public ContactUfficio Studi Clinici ed Attività R
Istituto Europeo di Oncologia
Outcome results
None listed