Doxorubicin Hydrochloride Liposome, Cyclophosphamide, and Trastuzumab in Treating Patients With Stage IV Breast Cancer
|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|
|Primary Completion Date :||February 2011|
|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).
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|