A Phase II Study Of Abraxane and Nexavar in the First-Line Treatment of Locally Advanced or Metastatic Breast Cancer
This is a Phase II, open-label, non-randomized study in patients with locally advanced or metastatic breast cancer.
Each cycle will be 4 weeks in length. Patients will receive Abraxane weekly for 3 weeks. Patients will not receive Abraxane during week 4 (rest week). Nexavar will be given continuously.
Patients will be radiologically evaluated every 8 weeks for response. Patients will continue to receive study treatment until disease progression or unacceptable toxicity.
|Breast Cancer||Drug: Paclitaxel Albumin Nanoparticle for Injectable Suspension (Abraxane) Drug: Sorafenib (Nexavar)||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Abraxane and Nexavar in the First-Line Treatment of Locally Advanced or Metastatic Breast Cancer|
- To evaluate the progression-free survival (PFS)and duration of response of the combination of weekly Abraxane and continuous Nexavar as first-line treatment for patients with locally advanced or metastatic breast cancer. [ Time Frame: Survival every 3 months for two years starting from the end of study date. Duration of response every 8 weeks while on treatment. ]
- To evaluate the response rate. [ Time Frame: Every 8 weeks while on study treatment. ]
- Evaluate the 1 and 2 year survival rate. [ Time Frame: Every 3 months for 2 years starting from the end of therapy visit date ]
- Evaluate the toxicities of the combination of Abraxane and Nexavar [ Time Frame: At each clinic visit or if reported by subject. ]
|Study Start Date:||September 2007|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Drug: Paclitaxel Albumin Nanoparticle for Injectable Suspension (Abraxane)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607438
|United States, Ohio|
|Columbus, Ohio, United States, 43215|
|Principal Investigator:||Barry Mirtsching, MD||Veeda Oncology|