Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138125
Status:
TERMINATED
Last Update Posted:
2020-10-19
First Post:
2005-08-29
Brief Title:
Fulvestrant andor Trastuzumab as First-Line Therapy in Treating Postmenopausal Women With Stage IV Breast Cancer
Sponsor:
Translational Oncology Research International
Organization:
Translational Oncology Research International
Study Overview
Official Title:
Phase II Randomized Trial of Faslodex and Herceptin Alone and Combined in the First - Line Treatment of Hormone Receptor-Positive HER-2Neu-Overexpressing Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Estrogen can cause the growth of breast cancer cells Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes Monoclonal antibodies such as trastuzumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them It is not yet known whether giving fulvestrant together with trastuzumab is more effective than giving fulvestrant or trastuzumab alone in treating breast cancer
PURPOSE This randomized phase II trial is studying how well fulvestrant andor trastuzumab works as first-line therapy in treating postmenopausal women with stage IV breast cancer
PURPOSE This randomized phase II trial is studying how well fulvestrant andor trastuzumab works as first-line therapy in treating postmenopausal women with stage IV breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare the overall objective response rate in postmenopausal women with estrogen receptor ER- andor progesterone receptor PR-positive HER2neu-overexpressing stage IV breast cancer treated with first-line therapy comprising fulvestrant andor trastuzumab Herceptin
Secondary
Compare the duration of response in patients treated with these regimens
Compare overall survival of patients treated with these regimens
Compare the antitumor activity of these regimens in terms of time to disease progression in these patients
Compare the clinical benefit of these regimens in these patients
Determine the safety and toxicity of these regimens in these patients
Correlate HER2neu expression and ER andor PR expression with response in patients treated with these regimens
OUTLINE This is a randomized controlled open-label multicenter study Patients are stratified according to prior adjuvant endocrine therapy yes vs no Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive fulvestrant intramuscularly on days 1 and 15 of course 1 and then on day 1 only in all subsequent courses
Arm II Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 15 and 22
Arm III Patients receive fulvestrant as in arm I in combination with trastuzumab as in arm II
In all arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 120 patients 40 per treatment arm will be accrued for this study
Primary
Compare the overall objective response rate in postmenopausal women with estrogen receptor ER- andor progesterone receptor PR-positive HER2neu-overexpressing stage IV breast cancer treated with first-line therapy comprising fulvestrant andor trastuzumab Herceptin
Secondary
Compare the duration of response in patients treated with these regimens
Compare overall survival of patients treated with these regimens
Compare the antitumor activity of these regimens in terms of time to disease progression in these patients
Compare the clinical benefit of these regimens in these patients
Determine the safety and toxicity of these regimens in these patients
Correlate HER2neu expression and ER andor PR expression with response in patients treated with these regimens
OUTLINE This is a randomized controlled open-label multicenter study Patients are stratified according to prior adjuvant endocrine therapy yes vs no Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive fulvestrant intramuscularly on days 1 and 15 of course 1 and then on day 1 only in all subsequent courses
Arm II Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 15 and 22
Arm III Patients receive fulvestrant as in arm I in combination with trastuzumab as in arm II
In all arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 120 patients 40 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| UCLA-0502057-01 | OTHER | None | None |
| TORI-B-04 | OTHER | None | None |
| 441350-RI-78322 | OTHER_GRANT | Genentech and AstraZeneca | None |