This is a phase II study of the combination of oxaliplatin and trastuzumab as first or second line therapy in patients with stage IV, metastatic breast cancer
Eligible patients will receive a minimum of six cycles of combination therapy. If a patient is still responding to the oxaliplatin at 6 cycles, the oxaliplatin may be continued with the trastuzumab up to 10 cycles at the investigator's discretion. After discontinuing the oxaliplatin/trastuzumab combination, patients should continue with single agent trastuzumab until disease progression. Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes. Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab
Graves-Gilbert Clinic
Bowling Green, Kentucky, United States
Hematology Oncology Life Center
Alexandria, Louisiana, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: 18 months
Time to Progression
Time-to-progression was defined as the interval from first study treatment until the date that breast cancer progression was documented, other treatment was given, or death occurred.
Time frame: 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Chattanooga Oncology and Hematology Associates
Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States