Phase 2b Study of Taxol Plus Sorafenib or Placebo in Patients With Advanced Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving paclitaxel together with sorafenib may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well paclitaxel works when given together with or without sorafenib in treating patients with locally recurrent or metastatic breast cancer.
Drug: sorafenib tosylate
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Randomized Phase 2b Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo When Administered in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Breast Cancer|
- Progression-free survival [ Time Frame: At disease progression or death ]
- Overall survival [ Time Frame: At time of death ]
- Time to progression [ Time Frame: At time of disease progression ]
- Overall response rate [ Time Frame: At the time of progression of disease ]
- Duration of overall response [ Time Frame: At time of disease progression ]
- Treatment-emergent adverse events as assessed by NCI CTCAE v3.0 [ Time Frame: During treatment and up to 30 days post-treatment ]
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive paclitaxel IV over 1 hour once weekly for 3 weeks. Patients also receive oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
given IVDrug: sorafenib tosylate
Active Comparator: Arm II
Patients receive paclitaxel as in arm I and oral placebo twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
given IVOther: placebo
- Compare progression-free survival of patients with locally recurrent or metastatic breast cancer treated with sorafenib tosylate and paclitaxel versus placebo and paclitaxel as first-line therapy.
- Compare the objective response rate and duration of response in patients treated with these regimens.
- Compare the time to progression in patients treated with these regimens.
- Compare the survival of patients treated with these regimens.
- Compare the safety of patients treated with these regimens.
- Compare the change from baseline in the Functional Assessment of Cancer Therapy for Breast Cancer quality of life assessment score in patients treated with these regimens.
OUTLINE: This is a double-blind, randomized, multicenter study. Patients are stratified according to site of metastatic disease (visceral [i.e., soft internal organs of the body, including lungs, heart, and the organs of the digestive, excretory, and reproductive systems] vs nonvisceral [i.e., osseous or soft tissue] sites). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive paclitaxel IV over 1 hour once weekly for 3 weeks. Patients also receive oral sorafenib tosylate twice daily on days 1-28.
- Arm II: Patients receive paclitaxel as in arm I and oral placebo twice daily on days 1-28.
In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, and every 8 weeks for 24 weeks, and then every 12 weeks for the duration of study participation.
After completion of study therapy, patients are followed every 4 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499525
Show 43 Study Locations
|Study Chair:||William J. Gradishar, MD||Robert H. Lurie Cancer Center|