Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002582
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
1999-11-01
Brief Title:
Tamoxifen Ovarian Ablation andor Chemotherapy in Treating Women With Stage I Stage II or Stage IIIA Breast Cancer
Sponsor:
Institute of Cancer Research United Kingdom
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
UKCCCR RANDOMISED TRIAL OF ADJUVANT ENDOCRINE THERAPY AND CHEMOTHERAPY IN WOMEN WITH EARLY BREAST CANCER THE ADJUVANT BREAST CANCER ABC 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 Combination chemotherapy uses 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 compare the effectiveness of tamoxifen with or without chemotherapy andor ovarian ablation in treating women with stage I stage II or stage IIIA breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy andor ovarian ablation in treating women with stage I stage II or stage IIIA breast cancer
Detailed Description:
OBJECTIVES
Estimate overall and relapse-free survival of women with early-stage breast cancer receiving adjuvant tamoxifen with or without adjuvant chemotherapy andor ovarian suppression
OUTLINE This is a randomized multicenter study Patients are stratified by participating institution and choice of randomization option
Postmenopausal women are randomized to the first or second groups
Randomization for pre- and perimenopausal women is based on the clinicians judgement of appropriate adjuvant therapy chemotherapy andor ovarian suppression Patients may be randomized as follows among all four groups for chemotherapy alone first versus second group for ovarian suppression alone first versus third group for ovarian suppression with nonrandomized assignment to chemotherapy second versus forth group for chemotherapy with nonrandomized assignment to ovarian suppression second versus fourth group
First group Patients receive tamoxifen by mouth every day for 5 years
Second group Patients receive tamoxifen plus cyclophosphamide methotrexate fluorouracil CMF or doxorubicincyclophosphamide AC CMF is given every month for 6 courses AC is given every 3 weeks for 4 courses
Third group Patients receive tamoxifen plus ovarian suppression by oophorectomy radiation castration or leuprolide or goserelin
Fourth group Patients receive tamoxifen plus ovarian suppression plus chemotherapy with CMF or AC
Patients are followed for overall and relapse-free survival
PROJECTED ACCRUAL Approximately 6000 women 4000 premenopausal 2000 postmenopausal will be accrued for this study
Estimate overall and relapse-free survival of women with early-stage breast cancer receiving adjuvant tamoxifen with or without adjuvant chemotherapy andor ovarian suppression
OUTLINE This is a randomized multicenter study Patients are stratified by participating institution and choice of randomization option
Postmenopausal women are randomized to the first or second groups
Randomization for pre- and perimenopausal women is based on the clinicians judgement of appropriate adjuvant therapy chemotherapy andor ovarian suppression Patients may be randomized as follows among all four groups for chemotherapy alone first versus second group for ovarian suppression alone first versus third group for ovarian suppression with nonrandomized assignment to chemotherapy second versus forth group for chemotherapy with nonrandomized assignment to ovarian suppression second versus fourth group
First group Patients receive tamoxifen by mouth every day for 5 years
Second group Patients receive tamoxifen plus cyclophosphamide methotrexate fluorouracil CMF or doxorubicincyclophosphamide AC CMF is given every month for 6 courses AC is given every 3 weeks for 4 courses
Third group Patients receive tamoxifen plus ovarian suppression by oophorectomy radiation castration or leuprolide or goserelin
Fourth group Patients receive tamoxifen plus ovarian suppression plus chemotherapy with CMF or AC
Patients are followed for overall and relapse-free survival
PROJECTED ACCRUAL Approximately 6000 women 4000 premenopausal 2000 postmenopausal 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-ABC | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000063697 | REGISTRY | None | None |
| CRC-TU-BR3010 | None | None | None |
| SCTN-BR9401BR9402 | None | None | None |
| YRCO-ABC | None | None | None |
| EU-94029 | None | None | None |