Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002864
Status:
COMPLETED
Last Update Posted:
2020-04-01
First Post:
1999-11-01
Brief Title:
Tamoxifen With or Without Octreotide in Treating Postmenopausal Women With Stage I Stage II or Stage III Breast Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Randomized Trial of Antiestrogen Therapy Versus Combined Antiestrogen and Octreotide Therapy in the Adjuvant Treatment of Breast Cancer in Post-Menopausal Women
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 with or without octreotide may fight breast cancer by blocking the uptake of estrogen It is not yet known which treatment regimen is more effective for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of tamoxifen with or without octreotide in treating postmenopausal women who have stage I stage II or stage III breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of tamoxifen with or without octreotide in treating postmenopausal women who have stage I stage II or stage III breast cancer
Detailed Description:
OBJECTIVES I Compare event-free recurrence-free and overall survival following adjuvant therapy with tamoxifen alone vs tamoxifen plus octreotide long-acting release formulation in postmenopausal women with stage IIIIII breast cancer II Compare the toxicity and quality of life associated with each treatment regimen III Compare the effects of each treatment regimen on insulin-like growth factor-I IGF-I physiology and study the relationship between IGF-I physiology and outcome
OUTLINE This is a randomized study Patients are stratified by participating institution when and whether they receive adjuvant chemotherapy axillary lymph node status and hormone receptor status All patients are randomized within 12 weeks of definitive surgery Patients receiving adjuvant chemotherapy prior to protocol treatment are randomized within 6 weeks after the last dose of chemotherapy One group of patients receives daily oral tamoxifen while a second group receives daily oral tamoxifen plus octreotide long-acting release formulation by monthly depot injection Treatment in both groups continues for 5 years or until disease recurrence or development of a second malignancy Patients are followed monthly for 4 months every 4 months for 3 years and every 6 months thereafter
PROJECTED ACCRUAL A total of 850 patients will be entered over 42 years in this multicenter study
OUTLINE This is a randomized study Patients are stratified by participating institution when and whether they receive adjuvant chemotherapy axillary lymph node status and hormone receptor status All patients are randomized within 12 weeks of definitive surgery Patients receiving adjuvant chemotherapy prior to protocol treatment are randomized within 6 weeks after the last dose of chemotherapy One group of patients receives daily oral tamoxifen while a second group receives daily oral tamoxifen plus octreotide long-acting release formulation by monthly depot injection Treatment in both groups continues for 5 years or until disease recurrence or development of a second malignancy Patients are followed monthly for 4 months every 4 months for 3 years and every 6 months thereafter
PROJECTED ACCRUAL A total of 850 patients will be entered over 42 years in this multicenter study
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-MA14 | None | None | None |
| NCI-V96-1060 | None | None | None |
| CDR0000065135 | OTHER | PDQ | None |