Status:
COMPLETED
Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 3 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (H...
Eligibility Criteria
Inclusion
- Female presenting with metastatic breast cancer.
- Tumor must have been tested by FISH/CISH for FGFR1 amplification.
- HER2 and HR status must have been determined.
- Patients must have HER2 negative breast cancer.
- Patients must have a documented disease progression as define by RECIST at baseline.
- Patients with HR+ disease:
- Must have received at least one prior endocrine therapy in the metastatic setting.
- Must have received no more than three lines of chemotherapy in the metastatic setting.
- Patients with HR- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting.
Exclusion
- Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
- Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation.
- Clinically significant resting bradycardia (\< 50 beats per minute).
- LVEF assessed by 2-D echocardiogram (ECHO) or Multiple gated acquisition scanning (MUGA)\< 45%.
- Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE).
- Uncontrolled hypertension defined by a SBP \> 150mm Hg and/or DBP \> 100mm Hg, with or without anti-hypertensive medication.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00958971
Start Date
July 1 2009
End Date
March 1 2011
Last Update
December 19 2020
Active Locations (38)
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1
Comprehensive Blood and Cancer Center Dept CBCC (3)
Bakersfield, California, United States, 93309
2
Tower Cancer Research
Beverly Hills, California, United States, 90211
3
UCLA/ University of California Los Angeles Div. of Hematology/Oncology
Los Angeles, California, United States, 90095
4
Cancer Care Associates Medical Group Dept. of CCA
Redondo Beach, California, United States, 90277