Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002581
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer
Sponsor:
Scottish Cancer Therapy Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PROTOCOL FOR THE SCOTTISH POSTMENOPAUSAL CHEMO-ENDOCRINE TRIAL
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 tamoxifen with or without combination chemotherapy in treating postmenopausal women with stage I or stage II breast cancer that can be surgically removed
PURPOSE Randomized phase III trial to compare the effectiveness of tamoxifen with or without combination chemotherapy in treating postmenopausal women with stage I or stage II breast cancer that can be surgically removed
Detailed Description:
OBJECTIVES I Compare the potential benefits of adjuvant tamoxifen with or without cyclophosphamide methotrexate and fluorouracil CMF in postmenopausal women with stage I-IIIA unilateral invasive breast cancer
OUTLINE This is a randomized study multicenter study Patients are stratified according to nodal status positive vs negative or unknown and hospital region Patients undergo surgical resection with or without local radiotherapy as appropriate Radiotherapy begins within 8 weeks of surgery for patients randomized to arm I and within 4 weeks after completion of chemotherapy for patients randomized to arm II Patients are randomized to 1 of 2 treatment arms preferably within 2 weeks after surgery Arm I Beginning within 4 weeks after surgery patients receive oral tamoxifen daily Treatment continues for 5 years Arm II Beginning within 4 weeks after surgery patients receive tamoxifen as in arm I and cyclophosphamide IV methotrexate IV and fluorouracil IV on day 1 CMF Chemotherapy continues every 3 weeks for 6 courses Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 1000 patients will be accrued for this study
OUTLINE This is a randomized study multicenter study Patients are stratified according to nodal status positive vs negative or unknown and hospital region Patients undergo surgical resection with or without local radiotherapy as appropriate Radiotherapy begins within 8 weeks of surgery for patients randomized to arm I and within 4 weeks after completion of chemotherapy for patients randomized to arm II Patients are randomized to 1 of 2 treatment arms preferably within 2 weeks after surgery Arm I Beginning within 4 weeks after surgery patients receive oral tamoxifen daily Treatment continues for 5 years Arm II Beginning within 4 weeks after surgery patients receive tamoxifen as in arm I and cyclophosphamide IV methotrexate IV and fluorouracil IV on day 1 CMF Chemotherapy continues every 3 weeks for 6 courses Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 1000 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 |
|---|---|---|---|
| UKCCCR-ABCBR9402 | None | None | None |
| SCTN-BR9402 | None | None | None |
| EU-94003 | None | None | None |