Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002579
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Tamoxifen Following Combination Chemotherapy in Treating Women With Operable Invasive Breast Cancer
Sponsor:
Scottish Cancer Therapy Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PROTOCOL FOR THE SCOTTISH CHEMO-ENDOCRINE TRIAL D
Status:
COMPLETED
Status Verified Date:
2007-05
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 Combining combination chemotherapy with hormone therapy may kill more tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without tamoxifen in treating women with stage I or stage II breast cancer that can be surgically removed
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without tamoxifen in treating women with stage I or stage II breast cancer that can be surgically removed
Detailed Description:
OBJECTIVES I Assess the disease-free and overall survival produced by adjuvant tamoxifen given after postoperative chemotherapy with cyclophosphamidemethotrexatefluorouracil CMF vs adjuvant CMF alone in women with primary breast cancer
OUTLINE This is a randomized study Patients are stratified by age and by participating institution All patients undergo surgical resection with local radiation therapy as appropriate Within 4 weeks of surgery patients receive cyclophosphamide methotrexate and fluorouracil CMF every 3 weeks for 6 courses Radiotherapy is given within 4 weeks of completion of CMF Before beginning the last course of CMF patients are randomized to receive either oral tamoxifen daily for 5 years or no further therapy Patients are followed every 6 months for 5 years then yearly Hormone therapy is prohibited except as specified above and except for short-term hormone replacement therapy for severe unresponsive menopausal symptoms
PROJECTED ACCRUAL Approximately 2000 patients will be required Data on patients entered in Scotland as part of this study will be pooled with data from the EORTC-10901 study
OUTLINE This is a randomized study Patients are stratified by age and by participating institution All patients undergo surgical resection with local radiation therapy as appropriate Within 4 weeks of surgery patients receive cyclophosphamide methotrexate and fluorouracil CMF every 3 weeks for 6 courses Radiotherapy is given within 4 weeks of completion of CMF Before beginning the last course of CMF patients are randomized to receive either oral tamoxifen daily for 5 years or no further therapy Patients are followed every 6 months for 5 years then yearly Hormone therapy is prohibited except as specified above and except for short-term hormone replacement therapy for severe unresponsive menopausal symptoms
PROJECTED ACCRUAL Approximately 2000 patients will be required Data on patients entered in Scotland as part of this study will be pooled with data from the EORTC-10901 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 |
|---|---|---|---|
| EU-94004 | None | None | None |
| SCTN-BR9403 | None | None | None |