Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047255
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2002-10-03
Brief Title:
Docetaxel and Trastuzumab With or Without Carboplatin in Treating Women With HER2-Positive Breast Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Multicenter Phase III Randomized Trial Comparing Docetaxel Taxotere and Trastuzumab Herceptin With Docetaxel Taxotere Carboplatin and Trastuzumab Herceptin as First Line Chemotherapy for Patients With Advanced Breast Cancer Containing the HER2 Gene Amplification
Status:
COMPLETED
Status Verified Date:
2016-02
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells It is not yet known if docetaxel and trastuzumab are more effective with or without carboplatin in treating women who have HER2-positive breast cancer
PURPOSE Randomized phase III trial to study the effectiveness of combining docetaxel and trastuzumab with or without carboplatin in treating women who have HER2-positive stage IIIB or stage IV breast cancer
PURPOSE Randomized phase III trial to study the effectiveness of combining docetaxel and trastuzumab with or without carboplatin in treating women who have HER2-positive stage IIIB or stage IV breast cancer
Detailed Description:
OBJECTIVES
Compare the time to disease progression in women with HER2-positive stage IIIB IIIC or IV breast cancer treated with docetaxel and trastuzumab Herceptin with or without carboplatin
Compare the response rate and duration of overall response in patients treated with these regimens
Compare the overall survival of patients treated with these regimens
Compare rate of clinical benefit defined as complete response partial response or stable disease for more than 24 weeks in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Determine pathologic and molecular markers for predicting efficacy of these regimens in these patients
Determine genetic and biochemical markers for predicting risk of cardiac dysfunction and later cardiac events in patients receiving these regimens
Determine whether peripheral levels of shed HER2 extracellular domain constitute a prognostic andor predictive factor of time to progression and survival of patients receiving these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to prior adjuvant andor neoadjuvant chemotherapy none vs with taxanes vs without taxanes and participating center Patients are randomized to 1 of 2 treatment arms
Arm I
Course 1 Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 and 15 Patients receive docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 2
Courses 2 and all subsequent courses Patients receive docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 1 and trastuzumab IV over 30 minutes on days 1 8 and 15
Arm II Patients receive docetaxel and trastuzumab as in arm I In both arms treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity After completion of 8 courses patients continue to receive trastuzumab IV over 30 minutes every 21 days in the absence of disease progression
Patients are followed every 2 months for 3 years
PROJECTED ACCRUAL A total of 250 patients 125 per treatment arm will be accrued for this study within 18 months
Compare the time to disease progression in women with HER2-positive stage IIIB IIIC or IV breast cancer treated with docetaxel and trastuzumab Herceptin with or without carboplatin
Compare the response rate and duration of overall response in patients treated with these regimens
Compare the overall survival of patients treated with these regimens
Compare rate of clinical benefit defined as complete response partial response or stable disease for more than 24 weeks in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Determine pathologic and molecular markers for predicting efficacy of these regimens in these patients
Determine genetic and biochemical markers for predicting risk of cardiac dysfunction and later cardiac events in patients receiving these regimens
Determine whether peripheral levels of shed HER2 extracellular domain constitute a prognostic andor predictive factor of time to progression and survival of patients receiving these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to prior adjuvant andor neoadjuvant chemotherapy none vs with taxanes vs without taxanes and participating center Patients are randomized to 1 of 2 treatment arms
Arm I
Course 1 Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 and 15 Patients receive docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 2
Courses 2 and all subsequent courses Patients receive docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 1 and trastuzumab IV over 30 minutes on days 1 8 and 15
Arm II Patients receive docetaxel and trastuzumab as in arm I In both arms treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity After completion of 8 courses patients continue to receive trastuzumab IV over 30 minutes every 21 days in the absence of disease progression
Patients are followed every 2 months for 3 years
PROJECTED ACCRUAL A total of 250 patients 125 per treatment arm will be accrued for this study within 18 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BCIRG-007 | OTHER | UCLA | None |
| UCLA-0109024 | OTHER | None | None |