Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014638
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2001-04-10
Brief Title:
Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
Open Label Multicenter Trial Of Femera Letrozole 25 mg As First-line Therapy In Postmenopausal Women With Metastatic Breast Cancer Relapsing Following Adjuvant Tamoxifen Therapy
Status:
COMPLETED
Status Verified Date:
2013-02
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 Estrogen can stimulate the growth of cancer cells Letrozole may fight breast cancer by reducing the production of estrogen
PURPOSE Phase IV trial to study the effectiveness of letrozole in treating postmenopausal women who have metastatic breast cancer that has been previously treated with tamoxifen
PURPOSE Phase IV trial to study the effectiveness of letrozole in treating postmenopausal women who have metastatic breast cancer that has been previously treated with tamoxifen
Detailed Description:
OBJECTIVES I Determine the time to progression of postmenopausal women with metastatic breast cancer treated with letrozole Femara as first-line therapy II Determine the objective response rate time to treatment failure survival rate and changes in symptom distress in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to time to diagnosis of metastatic disease Patients receive oral letrozole Femara daily Treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 590 patients will be accrued for this study
OUTLINE This is a multicenter study Patients are stratified according to time to diagnosis of metastatic disease Patients receive oral letrozole Femara daily Treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 590 patients 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 |
|---|---|---|---|
| NOVARTIS-CFEM345A-US10 | None | None | None |