Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338286
Status:
COMPLETED
Last Update Posted:
2018-03-19
First Post:
2006-06-16
Brief Title:
A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Randomized Open-label Multicenter Phase 3 Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the impact on tumor progression as evaluated by progression-free survival PFS of epoetin alfa plus standard supportive care as compared with standard supportive care alone packed red blood cell RBC transfusions for treating anemia according to label guidance in patients with metastatic breast cancer receiving standard chemotherapy
Detailed Description:
Anemia is a common complication of the treatment of metastatic breast cancer and is related to the effects of chemotherapy and to chronic disease itself This is a randomized open-label multicenter international study to further examine the safety of the study drug used with standard supportive care ie packed RBC transfusions compared to standard supportive care alone when used to treat anemia associated with chemotherapy This study will be done in subjects with metastatic breast cancer who are being or will be treated with first-line chemotherapy with standard dose schedules of taxane monotherapy or a taxane plus trastuzumab or an anthracycline plus either a taxane or cyclophosphamide The study hypothesis is that epoetin alfa when used as supportive anemia care does not increase the risk of tumor progression or death The study treatment will be compared to the control treatment by comparing progression-free survival ie the number of months from the date a patient is randomized into the trial to the date of the first documented disease progression or death In addition to their chemotherapy half of the subjects will be assigned to receive study drug epoetin alfa and half of the subjects will be assigned to standard supportive care for anemia Subjects treated with the study drug will receive standard supportive care packed RBC transfusions plus 40000 IU epoetin alfa given subcutaneously once a week until 4 weeks after the last cycle of chemotherapy or until disease progression whichever comes firstThe hypothesis is to test that epoetin alfa when used as supportive anemia care is non-inferior to control standard supportive care alone as measured by progression free survival PFS Patients treated with the study drug will receive standard supportive care packed red blood cells RBC transfusions plus 40000 IU epoetin alfa given subcutaneously once a week until 4 weeks after the last cycle of chemotherapy or until disease progression whichever comes first Dose adjustments dose escalation dose reduction dose interruption and dose resumption of epoetin alfa will be based on hemoglobin Hb and confirm to prescribing information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EPOANE3010 | OTHER | None | None |
| CR005143 | OTHER | None | None |
| 2005-001817-17 | EUDRACT_NUMBER | Janssen Research Development LLC | None |