Sorafenib and Fulvestrant in Treating Patients With Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Aromatase Inhibitor Therapy
- Registration Number
- NCT00722072
- Lead Sponsor
- OHSU Knight Cancer Institute
- Brief Summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving sorafenib together with fulvestrant may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sorafenib together with fulvestrant works in treating patients with locally advanced or metastatic breast cancer that did not respond to aromatase inhibitor therapy.
- Detailed Description
OBJECTIVES:
Primary
* To investigate the clinical activity of sorafenib tosylate and fulvestrant, as determined by a 4-month progression-free survival rate, in patients with hormone receptor-positive locally advanced or metastatic breast cancer that progressed after prior treatment with an aromatase inhibitor.
Secondary
* To determine the objective response rate in patients treated with this regimen.
* To determine the median time to progression in patients treated with this regimen.
* To determine the progression-free survival of patients treated with this regimen.
* To determine the overall survival of patients treated with this regimen.
* To establish the safety and tolerability profile of this regimen in these patients.
OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Patients also receive fulvestrant intramuscularly on days 1 and 15 of course 1 and on day 1 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 28-56 days.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fulvestrant/ Sorafenib sorafenib tosylate Fulvestrant: A loading dose will be administered intramuscularly to all subjects during cycle 1 of treatment as follows: * 500 mg IM on Day 1 * 250 mg IM on Day 15 Upon completion of the loading dose, a fixed dose of Fulvestrant 250 mg IM will be administered on day 1 of the next 28 day cycle and every consecutive cycle until tumor progression or unacceptable toxicity occurs requiring discontinuation. Sorafenib: Subjects will take Sorafenib 800 mg/day administered as 400 mg bid (twice daily)each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until unacceptable toxicity occurs. Fulvestrant/ Sorafenib fulvestrant Fulvestrant: A loading dose will be administered intramuscularly to all subjects during cycle 1 of treatment as follows: * 500 mg IM on Day 1 * 250 mg IM on Day 15 Upon completion of the loading dose, a fixed dose of Fulvestrant 250 mg IM will be administered on day 1 of the next 28 day cycle and every consecutive cycle until tumor progression or unacceptable toxicity occurs requiring discontinuation. Sorafenib: Subjects will take Sorafenib 800 mg/day administered as 400 mg bid (twice daily)each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until unacceptable toxicity occurs.
- Primary Outcome Measures
Name Time Method Number of Participants With Progression-free Survival at 4 Months 4 months after initiating treatment with sorafenib plus fulvestrant. Progression-free survival rate is defined as the proportion of subjects who are progression free (CR, PR and SD) at 4 months after initiating treatment with sorafenib plus fulvestrant. Complete Response (CR):Disappearance of all target (both measurable and evaluable)lesions. Partial Response (PR):At least a 30% decrease in the sum of the longest diameter (LD) of both measurable and evaluable target lesions. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease(PD).
- Secondary Outcome Measures
Name Time Method Time to Progression Start of treatment to time of progression. Progression-free Survival Start of treatment to time of progression or death, whichever comes first. Objective Response Rate Every 8 weeks (two cycles) while receiving study therapy. Overall Survival 28 to 56 days after discontinuation of study therapy
Trial Locations
- Locations (1)
OHSU Knight Cancer Institute
🇺🇸Portland, Oregon, United States