Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002777
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
RANDOMIZED PHASE II STUDY IN FIRST LINE HORMONAL TREATMENT FOR METASTATIC BREAST CANCER WITH EXEMESTANE OR TAMOXIFEN IN POSTMENOPAUSAL PATIENTS
Status:
COMPLETED
Status Verified Date:
2012-06
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 breast cancer cells Hormone therapy using exemestane or tamoxifen may fight cancer by blocking the uptake of estrogen
PURPOSE Randomized phase IIIII trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have locally recurrent or metastatic breast cancer
PURPOSE Randomized phase IIIII trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have locally recurrent or metastatic breast cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of exemestane vs tamoxifen in terms of progression-free survival in postmenopausal women with locally recurrent or metastatic breast cancer
Determine the safety profile of exemestane in these patients
Compare the overall survival of these patients treated with these regimens
OUTLINE This is a randomized multicenter study Phase II of this study closed as of 61400 Patients are stratified by participating center prior adjuvant tamoxifen yes vs no prior chemotherapy for metastatic disease yes vs no and dominant site of metastasis visceral with or without others vs bone only vs bone and soft tissue vs soft tissue only
Patients are randomized to receive either oral exemestane or oral tamoxifen daily Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 18 months and then at least every 6 months thereafter
PROJECTED ACCRUAL A total of 342 patients will be accrued for this study within 47 years
Compare the efficacy of exemestane vs tamoxifen in terms of progression-free survival in postmenopausal women with locally recurrent or metastatic breast cancer
Determine the safety profile of exemestane in these patients
Compare the overall survival of these patients treated with these regimens
OUTLINE This is a randomized multicenter study Phase II of this study closed as of 61400 Patients are stratified by participating center prior adjuvant tamoxifen yes vs no prior chemotherapy for metastatic disease yes vs no and dominant site of metastasis visceral with or without others vs bone only vs bone and soft tissue vs soft tissue only
Patients are randomized to receive either oral exemestane or oral tamoxifen daily Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 18 months and then at least every 6 months thereafter
PROJECTED ACCRUAL A total of 342 patients will be accrued for this study within 47 years
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 |
|---|---|---|---|
| PHARMACIA-EORTC-10951 | None | None | None |
| EORTC-10951 | None | None | None |