Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002460
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
1999-11-01
Brief Title:
Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer
Sponsor:
Cancer Research UK
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Study of Adjuvant Therapy With Tamoxifen vs Endocrine Ablation vs Tamoxifen Plus Endocrine Ablation vs No Adjuvant Therapy in Patients Under Age 50 With Operable Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2006-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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
PURPOSE Phase III trial to compare the effectiveness of adjuvant therapy using tamoxifen or ovarian ablation with goserelin or both in treating women with stage I or stage II breast cancer
PURPOSE Phase III trial to compare the effectiveness of adjuvant therapy using tamoxifen or ovarian ablation with goserelin or both in treating women with stage I or stage II breast cancer
Detailed Description:
OBJECTIVES I Determine in a prospective randomized controlled trial whether the administration of a course of adjuvant tamoxifen or ablation of ovarian function results in prolongation of time to recurrence or death in patients under 50 years of age with operable carcinoma of the breast II Determine how hormone manipulation affects mood and sexual functioning in these patients
OUTLINE This is a randomized study Patients are stratified by clinician All patients are randomized following primary therapy which in addition to surgery may include local irradiation perioperative cyclophosphamide or up to 6 cycles of cyclophosphamide methotrexate and fluorouracil CMF for high-risk patients Clinicians may elect to randomize patients to all groups or to only those groups including tamoxifen The first group receives no further therapy Then second group receives tamoxifen daily for at least 2 years The third group receives ovarian ablation with goserelin via monthly injection for at least 2 years The final group receives ovarian ablation with goserelin plus daily tamoxifen for at least 2 years All patients are followed every 3 months for 2 years every 6 months for 3 years then annually
PROJECTED ACCRUAL 800 to 1000 patients will be entered
OUTLINE This is a randomized study Patients are stratified by clinician All patients are randomized following primary therapy which in addition to surgery may include local irradiation perioperative cyclophosphamide or up to 6 cycles of cyclophosphamide methotrexate and fluorouracil CMF for high-risk patients Clinicians may elect to randomize patients to all groups or to only those groups including tamoxifen The first group receives no further therapy Then second group receives tamoxifen daily for at least 2 years The third group receives ovarian ablation with goserelin via monthly injection for at least 2 years The final group receives ovarian ablation with goserelin plus daily tamoxifen for at least 2 years All patients are followed every 3 months for 2 years every 6 months for 3 years then annually
PROJECTED ACCRUAL 800 to 1000 patients will be entered
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 |
|---|---|---|---|
| UKM-CRC-BR-UNDER 50 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000075539 | REGISTRY | None | None |