Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053339
Status:
WITHDRAWN
Last Update Posted:
2016-07-12
First Post:
2003-01-27
Brief Title:
Trastuzumab With or Without Tamoxifen in Treating Women With Progressive Stage IV Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Randomized Study of Trastuzumab Herceptin With or Without Tamoxifen in Women With Progressive Stage IV Estrogen or Progesterone Receptor- and HER2Neu-Positive Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was not activated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Estrogen can stimulate the growth of breast cancer cells Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen Combining trastuzumab with tamoxifen may kill more tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of trastuzumab with or without trastuzumab in treating women who have invasive stage IV breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of trastuzumab with or without trastuzumab in treating women who have invasive stage IV breast cancer
Detailed Description:
OBJECTIVES
Compare time to progression in women with progressive stage IV estrogen or progesterone receptor- and HER2neu-positive breast cancer treated with trastuzumab Herceptin with or without tamoxifen
Correlate response with type of measurement immunohistochemistry or fluorescent in situ hybridization of HER2neu expression in patients treated with these regimens
Compare objective response rate complete or partial response in patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to prior adjuvant treatment yes vs no ECOG performance status 0-1 vs 2 and prior aromatase inhibitor treatment yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive trastuzumab Herceptin IV over 60-90 minutes on day 1
Arm II Patients receive trastuzumab as in arm I and oral tamoxifen once daily on days 1-21
In both arms treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 5 years
PROJECTED ACCRUAL A total of 280 patients 140 per treatment arm will be accrued for this study within 28 months
Compare time to progression in women with progressive stage IV estrogen or progesterone receptor- and HER2neu-positive breast cancer treated with trastuzumab Herceptin with or without tamoxifen
Correlate response with type of measurement immunohistochemistry or fluorescent in situ hybridization of HER2neu expression in patients treated with these regimens
Compare objective response rate complete or partial response in patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to prior adjuvant treatment yes vs no ECOG performance status 0-1 vs 2 and prior aromatase inhibitor treatment yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive trastuzumab Herceptin IV over 60-90 minutes on day 1
Arm II Patients receive trastuzumab as in arm I and oral tamoxifen once daily on days 1-21
In both arms treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 5 years
PROJECTED ACCRUAL A total of 280 patients 140 per treatment arm will be accrued for this study within 28 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 |
|---|---|---|---|
| CDR0000269409 | REGISTRY | PDQ Physician Data Query | None |