Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002542
Status:
COMPLETED
Last Update Posted:
2020-04-01
First Post:
1999-11-01
Brief Title:
Tamoxifen in Treating Women With High-Risk Breast Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
Double-Blind Randomized Trial of Tamoxifen Versus Placebo in Patients With Node Positive or High Risk Node Negative Breast Cancer Who Have Completed CMF CEF or AC Adjuvant Chemotherapy
Status:
COMPLETED
Status Verified Date:
2020-03
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 tamoxifen may fight breast cancer by blocking the uptake of estrogen Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase III trial to study the effectiveness of tamoxifen following surgery and chemotherapy in treating women who have stage I breast cancer at high risk of recurrence or stage II or stage III breast cancer
PURPOSE Phase III trial to study the effectiveness of tamoxifen following surgery and chemotherapy in treating women who have stage I breast cancer at high risk of recurrence or stage II or stage III breast cancer
Detailed Description:
OBJECTIVES I Compare the duration of overall survival and disease-free survival in premenopausal women with operable high risk node negative or axillary node-positive breast cancer who have undergone complete surgical resection of all known disease by means of total or partial mastectomy and have received standard adjuvant chemotherapy with cyclophosphamide methotrexate and fluorouracil CMF cyclophosphamide epirubicin and fluorouracil CEF or doxorubicin and cyclophosphamide AC followed by either daily tamoxifen for 5 years or placebo II Compare the short- and long-term toxicity in patients receiving tamoxifen versus placebo III Monitor follicle-stimulating hormone luteinizing hormone and estradiol levels and determine whether overall survival and disease-free survival are affected by hormonal or menopausal status during or at completion of adjuvant chemotherapy or during or after tamoxifen or placebo treatment in these patients
OUTLINE This is a randomized double blind study Patients are stratified by adjuvant chemotherapy regimen cyclophosphamide epirubicin and fluorouracil vs cyclophosphamide methotrexate and fluorouracil vs cyclophosphamide and doxorubicin hormone receptor status ER andor PR positive vs ER and PR negative number of positive nodes 1-3 vs 4-9 vs 10 or more and participating institution Patients receive one of three regimens of adjuvant chemotherapy at the discretion of the investigator Regimen A Patients receive oral cyclophosphamide on days 1-14 and epirubicin IV and fluorouracil IV on days 1 and 8 Courses repeat every 28 days for a total of 6 courses Following chemotherapy lumpectomy patients receive local radiotherapy daily for 5 weeks Regimen B Patients receive oral cyclophosphamide on days 1-14 or cyclophosphamide IV on day 1 and 8 methotrexate on days 1 and 8 and fluorouracil IV on days 1 and 8 Courses repeat every 28 days for a total of 6 courses Concurrent with or following chemotherapy lumpectomy patients receive local radiotherapy daily for 5 weeks Regimen C Patients receive doxorubicin IV and cyclophosphamide IV every 21 days for a total of 4 courses Following chemotherapy lumpectomy patients receive local radiotherapy daily for 5 weeks Patients are then randomized to receive either oral tamoxifen or a placebo once daily for 5 years beginning within 6 weeks of completion of chemotherapy Treatment continues in the absence of disease progression or unacceptable toxicity Patients are followed for survival
PROJECTED ACCRUAL A total of 800 patients will be accrued for this study over 4 years
OUTLINE This is a randomized double blind study Patients are stratified by adjuvant chemotherapy regimen cyclophosphamide epirubicin and fluorouracil vs cyclophosphamide methotrexate and fluorouracil vs cyclophosphamide and doxorubicin hormone receptor status ER andor PR positive vs ER and PR negative number of positive nodes 1-3 vs 4-9 vs 10 or more and participating institution Patients receive one of three regimens of adjuvant chemotherapy at the discretion of the investigator Regimen A Patients receive oral cyclophosphamide on days 1-14 and epirubicin IV and fluorouracil IV on days 1 and 8 Courses repeat every 28 days for a total of 6 courses Following chemotherapy lumpectomy patients receive local radiotherapy daily for 5 weeks Regimen B Patients receive oral cyclophosphamide on days 1-14 or cyclophosphamide IV on day 1 and 8 methotrexate on days 1 and 8 and fluorouracil IV on days 1 and 8 Courses repeat every 28 days for a total of 6 courses Concurrent with or following chemotherapy lumpectomy patients receive local radiotherapy daily for 5 weeks Regimen C Patients receive doxorubicin IV and cyclophosphamide IV every 21 days for a total of 4 courses Following chemotherapy lumpectomy patients receive local radiotherapy daily for 5 weeks Patients are then randomized to receive either oral tamoxifen or a placebo once daily for 5 years beginning within 6 weeks of completion of chemotherapy Treatment continues in the absence of disease progression or unacceptable toxicity Patients are followed for survival
PROJECTED ACCRUAL A total of 800 patients will be accrued for this study over 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CAN-NCIC-MA12 | None | None | None |
| NCI-V93-0323 | None | None | None |
| CDR0000063224 | OTHER | PDQ | None |