Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028704
Status:
TERMINATED
Last Update Posted:
2012-07-18
First Post:
2002-01-04
Brief Title:
Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Conservative Local Treatment Versus Mastectomy After Induction Chemotherapy In Locally Advanced Breast Cancer A Randomized Phase III Study
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Breast-conserving treatments such as radiation therapy or limited surgery are less invasive than mastectomy and may improve the quality of life It is not yet known if breast-conserving treatments are as effective as mastectomy followed by radiation therapy in treating locally advanced breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of breast-conserving therapy with mastectomy followed by radiation therapy in treating women who have locally advanced breast cancer that has been previously treated with chemotherapy
PURPOSE Randomized phase III trial to compare the effectiveness of breast-conserving therapy with mastectomy followed by radiation therapy in treating women who have locally advanced breast cancer that has been previously treated with chemotherapy
Detailed Description:
OBJECTIVES
Compare the overall survival and time to loco-regional failure in women with locally advanced breast cancer treated with breast-conserving local therapy vs mastectomy followed by radiotherapy after they have received prior induction chemotherapy
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center initial stage T0 T1 T2 T3 or Tx vs T4 response to prior induction chemotherapy complete response CR vs other and menopausal status premenopausal vs postmenopausal Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo mastectomy followed by radiotherapy
Arm II Patients receive breast-conserving treatment comprising 1 of 3 of the following therapeutic options
Regimen A Patients receive radiotherapy alone
Regimen B Patients with a partial response PR to prior induction chemotherapy undergo limited surgery followed by radiotherapy Patients with a CR to prior induction chemotherapy undergo radiotherapy alone
Regimen C Patients with a partial response PR or CR to prior induction chemotherapy undergo radiotherapy alone
Patients with a CR to radiotherapy receive no further treatment Patients with a PR to radiotherapy undergo limited surgery
Quality of life is assessed at baseline at the end of therapy every 3 months for 2 years every 6 months for 3 years and then annually thereafter
Patients are followed within 1 month every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 1300 patients 650 per treatment arm will be accrued for this study within 5 years
Compare the overall survival and time to loco-regional failure in women with locally advanced breast cancer treated with breast-conserving local therapy vs mastectomy followed by radiotherapy after they have received prior induction chemotherapy
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center initial stage T0 T1 T2 T3 or Tx vs T4 response to prior induction chemotherapy complete response CR vs other and menopausal status premenopausal vs postmenopausal Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo mastectomy followed by radiotherapy
Arm II Patients receive breast-conserving treatment comprising 1 of 3 of the following therapeutic options
Regimen A Patients receive radiotherapy alone
Regimen B Patients with a partial response PR to prior induction chemotherapy undergo limited surgery followed by radiotherapy Patients with a CR to prior induction chemotherapy undergo radiotherapy alone
Regimen C Patients with a partial response PR or CR to prior induction chemotherapy undergo radiotherapy alone
Patients with a CR to radiotherapy receive no further treatment Patients with a PR to radiotherapy undergo limited surgery
Quality of life is assessed at baseline at the end of therapy every 3 months for 2 years every 6 months for 3 years and then annually thereafter
Patients are followed within 1 month every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 1300 patients 650 per treatment arm will be accrued for this study within 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 |
|---|---|---|---|
| LAMANOMA | None | None | None |
| EORTC-10974 | None | None | None |
| CEEOG-EORTC-10974 | None | None | None |
| EORTC-22002 | None | None | None |
| GOCCHI-EORTC-10974 | None | None | None |
| ICCG-EORTC-10974 | None | None | None |
| EORTC-BIG-0002 | None | None | None |