A Phase II Trial of Abraxane™ Given Weekly as a Single Agent in First-line Treatment of Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00251472|
Recruitment Status : Completed
First Posted : November 10, 2005
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 of treatment will be 4 weeks in length. 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|
|Metastatic Breast Cancer||Drug: Paclitaxel Albumin Nanoparticle for Injectable Suspension||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Abraxane™ Given Weekly as a Single Agent in First-line Treatment of Metastatic Breast Cancer|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
- Drug: Paclitaxel Albumin Nanoparticle for Injectable Suspension
125mg/m2 by 30-minute IV infusion, once a week.
- To assess the response rate of Abraxane given weekly as first-line treatment for patients with locally advanced or metastatic breast cancer. [ Time Frame: unk ]
- To assess time to progression (TTP), overall survival (OS), and toxicities of Abraxane as first-line treatment for patients with locally advanced or metastatic breast cancer. [ Time Frame: unk ]
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): NCT00251472
|United States, Ohio|
|Columbus, Ohio, United States, 43215|
|Principal Investigator:||Barry Mirtsching, MD||Veeda Oncology|