Doxorubicin Hydrochloride Liposome, Cyclophosphamide, and Trastuzumab in Treating Patients With Stage IV Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00331552|
Recruitment Status : Completed
First Posted : May 31, 2006
Results First Posted : July 26, 2017
Last Update Posted : July 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|HER2-positive Breast Cancer Male Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer||Drug: pegylated liposomal doxorubicin hydrochloride Drug: cyclophosphamide Biological: trastuzumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I - II Study of Doxil® In Combination With Daily Oral Cyclophosphamide and Herceptin for Patients With HER-2/Neu Positive Disease In Patients With Metastatic Breast Cancer|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2012|
U.S. FDA Resources
Experimental: Arm I
Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
Drug: pegylated liposomal doxorubicin hydrochloride
Other Names:Drug: cyclophosphamide
Other Names:Biological: trastuzumab
- Maximum Tolerated Dose and Optimal Tolerated Dose of Pegylated Liposomal Doxorubicin Hydrochloride (Doxil) When Given in Combination With Cyclophosphamide (Phase I) [ Time Frame: Up to 24 weeks ]The dose level in which 2 or more patients develop treatment-related toxicity of grade 3 or higher OR require a dose adjustment following the first course of treatment
- Efficacy as Assessed by the Overall Clinical Benefit Rate [ Time Frame: 18 months ]Count of participants with a clinical benefit (i.e., complete response, partial response, and stable disease).
- Safety as Assessed by Grade 1, 2, 3, 4, Fatal Toxicity, Need for Dose Reduction, Treatment Interruption, or Treatment Discontinuation [ Time Frame: Periodically during study treatment, up to 24 weeks ]Count of participants with grade 1, 2, 3, 4, fatal toxicity, need for dose reduction, treatment interruption, or treatment discontinuation
- Treatment-related Toxicity (Phase I) [ Time Frame: Up to 24 weeks ]Count of phase I participants with treatment related toxicity.
- Time to Progression (Phase II) [ Time Frame: Up to 2 years ]Median time to progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions or new effusions.
- Progression-free Survival (Phase II) [ Time Frame: 18 months ]Kaplan-Meier estimate assessed at 18 months
- Overall Survival (Phase II) [ Time Frame: 18 months ]Kaplan-Meier estimate assessed at 18 months
- Comparison of Clinical Benefit Rate in 2 Subgroups--heavily Pre-treated (1 or More Regimens for Advanced Disease) vs Less Heavily Pre-treated (no Regimens for Advanced Disease) (Phase II) [ Time Frame: Up to 24 weeks ]Count of participants with a clinical benefit (i.e., complete response, partial response, and stable disease).
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): NCT00331552
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Hannah Linden||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|