A Phase II Study Of Abraxane and Nexavar in the First-Line Treatment of Locally Advanced or Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00607438|
Recruitment Status : Terminated (Low accrual)
First Posted : February 5, 2008
Last Update Posted : May 11, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Paclitaxel Albumin Nanoparticle for Injectable Suspension (Abraxane) Drug: Sorafenib (Nexavar)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Abraxane and Nexavar in the First-Line Treatment of Locally Advanced or Metastatic Breast Cancer|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
- Drug: Paclitaxel Albumin Nanoparticle for Injectable Suspension (Abraxane)
125 mg/m2 Paclitaxel by 30-minute IV infusion weekly for 3 weeks.Other Name: Abraxane
- Drug: Sorafenib (Nexavar)
400 mg orally twice a day continuously (even during rest week) starting on Day 1.Other Name: Nexavar
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607438
|United States, Ohio|
|Columbus, Ohio, United States, 43215|
|Principal Investigator:||Barry Mirtsching, MD||Veeda Oncology|