Same Day Dosing of Pegfilgrastim in Breast Cancer Patients Undergoing Chemotherapy (TAC)
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia. |
|---|---|
| Condition | Breast Cancer Fever Neutropenia |
| Intervention | Drug: pegfilgrastim Drug: docetaxel Drug: doxorubicin Drug: cyclophosphamide |
| Phase | Phase 2 |
| Sponsor | Amgen |
| Responsible Party | Amgen |
| ClinicalTrials.gov Identifier | NCT00115414 |
| First Received | June 22, 2005 |
| Last Updated | July 31, 2008 |
| Last verified | July 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 22, 2005 |
|---|---|
| Last Updated Date | July 31, 2008 |
| Start Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Neutropenia |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Same Day Dosing of Pegfilgrastim in Breast Cancer Patients Undergoing Chemotherapy (TAC) |
|---|---|
| Official Title | A Randomized, Double-Blind, Phase 2 Study Evaluating the Safety of Same Day Versus Next Day Administration of Pegfilgrastim With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) in Women With Breast Cancer |
| Brief Summary | The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: pegfilgrastim Drug: docetaxel Drug: doxorubicin Drug: cyclophosphamide |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | Not Provided |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - Breast cancer, previously untreated Exclusion Criteria: - Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, antiviral) within 72 hours of chemotherapy - Prior malignancy within the last 5 years, with the exception of surgically cured basal/squamous skin cell carcinoma, ductal carcinoma in situ of the breast and/or carcinoma of the cervix in situ - History of impaired cardiac status (e.g., severe heart disease, cardiomyopathy or congestive heart failure) - Major surgery within 2 weeks prior to randomization - Previous exposure to cytokines within two weeks prior - Concurrent use of other investigational agents |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00115414 |
|---|---|
| Other Study ID Numbers | 20020778 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Amgen |
| Study Sponsor | Amgen |
| Collaborators | Not Provided |
| Investigators | Study Director: MD Amgen |
| Verification Date | July 2008 |