Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146549
Status:
COMPLETED
Last Update Posted:
2009-11-01
First Post:
2005-09-02
Brief Title:
Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Randomized Phase III Study of Trastuzumab Herceptin in Combination With Either Vinorelbine Navelbine or Taxane-based Chemotherapy in Patients With HER2 Overexpressing Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2009-10
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 compare two different combinations of chemotherapy with trastuzumab as initial treatment for HER2 positive advanced breast cancer Half of the patients will receive trastuzumab in combination with a taxane form of chemotherapy either paclitaxel or docetaxel while the other group will receive trastuzumab in combination with vinorelbine
Detailed Description:
All patients will receive trastuzumab then be randomized into one of two arms Arm A Trastuzumab in combination with weekly vinorelbine and Arm B Trastuzumab in combination with a weekly taxane-based regimen either paclitaxel or docetaxel chosen at the discretion of the investigator
Treatment is administered on an outpatient basis Trastuzumab is administered weekly There is a one-time loading dose for the first week of the first cycle For that initial treatment only the trastuzumab dose is 4mgkg The dose for all subsequent weekly trastuzumab treatments is 2mgkg
Arm A vinorelbine is administered every week and the dose is adjusted based on the absolute neutrophil count for that week Vinorelbine is given after trastuzumab
Arm B Either paclitaxel given weekly dose bases on absolute neutrophil count or docetaxel given on weeks 123567 of each 8-week cycle dose based upon absolute neutrophil count Patients on paclitaxel will also receive dexamethasone diphenhydramine and ranitidine to help prevent allergic or hypersensitivity reactions Patients on docetaxel will receive dexamethasone to help reduce fluid retention or edema
Every 8 weeks the patients cancer will be re-evaluated to see if the treatment is working If the treatment appears to be working treatment will continue Standard radiological testing x-rays CT scan radioactive drug scans or MRIs will be used to follow the disease treatment
Heart function will be measured after 16 weeks to be sure it is safe to continue treatment
Every 8 weeks patients will be asked to complete a brief written survey that asks about symptoms and side effects
Patients will remain on the treatment as long as there is no disease progression or unacceptable side effects
Treatment is administered on an outpatient basis Trastuzumab is administered weekly There is a one-time loading dose for the first week of the first cycle For that initial treatment only the trastuzumab dose is 4mgkg The dose for all subsequent weekly trastuzumab treatments is 2mgkg
Arm A vinorelbine is administered every week and the dose is adjusted based on the absolute neutrophil count for that week Vinorelbine is given after trastuzumab
Arm B Either paclitaxel given weekly dose bases on absolute neutrophil count or docetaxel given on weeks 123567 of each 8-week cycle dose based upon absolute neutrophil count Patients on paclitaxel will also receive dexamethasone diphenhydramine and ranitidine to help prevent allergic or hypersensitivity reactions Patients on docetaxel will receive dexamethasone to help reduce fluid retention or edema
Every 8 weeks the patients cancer will be re-evaluated to see if the treatment is working If the treatment appears to be working treatment will continue Standard radiological testing x-rays CT scan radioactive drug scans or MRIs will be used to follow the disease treatment
Heart function will be measured after 16 weeks to be sure it is safe to continue treatment
Every 8 weeks patients will be asked to complete a brief written survey that asks about symptoms and side effects
Patients will remain on the treatment as long as there is no disease progression or unacceptable side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None