Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002580
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Tamoxifen Ovarian Ablation andor Combination Chemotherapy in Treating Premenopausal Women With Stage I Stage II or Stage IIIA Invasive Breast Cancer
Sponsor:
Scottish Cancer Therapy Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PROTOCOL FOR THE SCOTTISH PREMENOPAUSAL 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 Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with hormone therapy may kill more tumor cells It is not yet known which treatment regimen is most effective for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of tamoxifen with that of ovarian ablation andor combination chemotherapy in treating premenopausal women with stage I stage II or stage IIIA breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of tamoxifen with that of ovarian ablation andor combination chemotherapy in treating premenopausal women with stage I stage II or stage IIIA breast cancer
Detailed Description:
OBJECTIVES I Compare the potential benefits of adjuvant tamoxifen with or without ovarian suppression andor cyclophosphamide methotrexate and fluorouracil CMF in premenopausal women with stage I-IIIA unilateral invasive breast cancer
OUTLINE This is a randomized 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 after surgery for patients randomized to arm I or III and within 4 weeks after completion of chemotherapy for patients randomized to arm II or IV Patients are randomized to 1 of 4 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 in the absence of disease progression or unacceptable toxicity Arm II Beginning within 4 weeks after surgery patients receive tamoxifen as in arm I and cyclophosphamide IV methotrexate IV and fluorouracil IV CMF on day 1 Chemotherapy continues every 3 weeks for 6 courses Arm III Beginning within 4 weeks after surgery patients receive tamoxifen as in arm I and 1 of 3 ovarian suppression regimens preferably regimen A Regimen B is the preferred alternative to regimen A Regimen A Patients undergo oophorectomy Regimen B Patients undergo radiation-induced menopause comprising radiotherapy to the pelvis on days 1-4 Regimen C Beginning 4 weeks after surgery patients receive goserelin subcutaneously SC or leuprolide SC or intramuscularly on day 1 Treatment continues every 4 weeks for 2 years Arm IV Patients receive tamoxifen as in arm I and CMF as in arm II followed within 4 weeks by ovarian suppression as in arm III 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 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 after surgery for patients randomized to arm I or III and within 4 weeks after completion of chemotherapy for patients randomized to arm II or IV Patients are randomized to 1 of 4 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 in the absence of disease progression or unacceptable toxicity Arm II Beginning within 4 weeks after surgery patients receive tamoxifen as in arm I and cyclophosphamide IV methotrexate IV and fluorouracil IV CMF on day 1 Chemotherapy continues every 3 weeks for 6 courses Arm III Beginning within 4 weeks after surgery patients receive tamoxifen as in arm I and 1 of 3 ovarian suppression regimens preferably regimen A Regimen B is the preferred alternative to regimen A Regimen A Patients undergo oophorectomy Regimen B Patients undergo radiation-induced menopause comprising radiotherapy to the pelvis on days 1-4 Regimen C Beginning 4 weeks after surgery patients receive goserelin subcutaneously SC or leuprolide SC or intramuscularly on day 1 Treatment continues every 4 weeks for 2 years Arm IV Patients receive tamoxifen as in arm I and CMF as in arm II followed within 4 weeks by ovarian suppression as in arm III 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-ABCBR9401 | None | None | None |
| SCTN-BR9401 | None | None | None |
| EU-94002 | None | None | None |