Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002967
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Octreotide Tamoxifen and Chemotherapy in Treating Women With Breast Cancer
Sponsor:
NSABP Foundation Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Clinical Trial to Evaluate the Benefit of Adding Octreotide SMS 201-995 PA LAR to Tamoxifen Alone or to Tamoxifen and Chemotherapy in Patients With Axillary Node-Negative Estrogen-Receptor-Positive Primary Invasive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining hormone therapy with chemotherapy may kill more tumor cells
PURPOSE Randomized phase III trial to study the effectiveness of tamoxifen octreotide and chemotherapy in treating women who have stage I or stage II breast cancer
PURPOSE Randomized phase III trial to study the effectiveness of tamoxifen octreotide and chemotherapy in treating women who have stage I or stage II breast cancer
Detailed Description:
OBJECTIVES I Determine whether the addition of octreotide pamoate to tamoxifen alone or to tamoxifen and chemotherapy improves the disease free survival of patients with primary invasive breast cancer with estrogen receptor ER positive tumors and histologically negative axillary lymph nodes or histologically negative sentinel lymph nodes if participating in NSABP B-32 II Determine whether the rate of endometrial cancer associated with tamoxifen is altered by the concurrent administration of octreotide pamoate III Determine whether the addition of octreotide pamoate to tamoxifen decreases the rate of opposite breast cancer more than tamoxifen alone IV Evaluate the incidence of gallstone formation including the development of symptoms and complications of biliary tract disease hyper and hypoglycemia hypothyroidism and vitamin B12 deficiency in patients treated with octreotide pamoate in comparison with patients not treated with octreotide pamoate
OUTLINE This is a randomized study Patients are randomized into one of four treatment arms Arm I Patients receive oral tamoxifen TMX daily continously for 5 years Lumpectomy patients receive breast radiotherapy following recovery from surgery Arm II Patients receive TMX as in Arm I and octreotide pamoate SMS 201-995 pa LAR intramuscularly IM every 21 days for 4 doses followed by octreotide pamoate IM for 28 days for 23 additional doses Lumpectomy patients receive breast radiotherapy following recovery from surgery Arm III Patients receive doxorubicin DOX IV and cyclophosphamide CTX IV every 3 weeks for 4 courses and TMX as in Arm I Lumpectomy patients receive breast radiotherapy after recovery from chemotherapy Arm IV Patients receive DOX and CTX as in Arm III TMX as in Arm I and octreotide pamoate as in Arm II Patients receive TMX and octreotide pamoate on day 1 of first course of chemotherapy Lumpectomy patients receive breast radiotherapy after recovery from chemotherapy
PROJECTED ACCRUAL Total accrual of 3000 patients will be acrrued for this study over 5 years
OUTLINE This is a randomized study Patients are randomized into one of four treatment arms Arm I Patients receive oral tamoxifen TMX daily continously for 5 years Lumpectomy patients receive breast radiotherapy following recovery from surgery Arm II Patients receive TMX as in Arm I and octreotide pamoate SMS 201-995 pa LAR intramuscularly IM every 21 days for 4 doses followed by octreotide pamoate IM for 28 days for 23 additional doses Lumpectomy patients receive breast radiotherapy following recovery from surgery Arm III Patients receive doxorubicin DOX IV and cyclophosphamide CTX IV every 3 weeks for 4 courses and TMX as in Arm I Lumpectomy patients receive breast radiotherapy after recovery from chemotherapy Arm IV Patients receive DOX and CTX as in Arm III TMX as in Arm I and octreotide pamoate as in Arm II Patients receive TMX and octreotide pamoate on day 1 of first course of chemotherapy Lumpectomy patients receive breast radiotherapy after recovery from chemotherapy
PROJECTED ACCRUAL Total accrual of 3000 patients will be acrrued for this study over 5 years
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 |
|---|---|---|---|
| NSABP-B-29 | None | None | None |