Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074152
Status:
COMPLETED
Last Update Posted:
2017-06-16
First Post:
2003-12-10
Brief Title:
Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer
Sponsor:
ETOP IBCSG Partners Foundation
Organization:
ETOP IBCSG Partners Foundation
Study Overview
Official Title:
A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-05
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:
CALOR
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether chemotherapy is effective in treating women who have undergone surgery and radiation therapy for relapsed breast cancer
PURPOSE Randomized phase III trial to determine the effectiveness of adjuvant chemotherapy in treating women who have undergone resection for local andor regional relapsed breast cancer
PURPOSE Randomized phase III trial to determine the effectiveness of adjuvant chemotherapy in treating women who have undergone resection for local andor regional relapsed breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of adjuvant chemotherapy in terms of disease-free survival in women with radically resected loco-regional relapsed breast cancer
Secondary
Determine the systemic disease-free and overall survival of patients treated with this regimen
Determine the sites of recurrence incidence of second non-breast malignancies and causes of death without relapse of breast cancer in patients treated with this regimen
Determine the quality of life of patients treated with this regimen QOL portion closed 111308
OUTLINE This is a randomized multicenter study Patients are stratified according to prior chemotherapy yes vs no estrogen receptor ER positive andor progesterone receptor PR positive yes vs no and location of recurrence breast vs mastectomy scarchest wall vs regional lymph nodes Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive radiotherapy within 6 months after surgery
Arm II Within 10 weeks after surgery patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator Patients also receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy
NOTE Patients with clear margins R0 who received prior adjuvant radiotherapy are not required to receive further radiotherapy
Patients with ER andor PR positive tumors also receive standard hormonal therapy
Quality of life is assessed at baseline and at 9 and 12 months QOL portion closed 111308
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 265 patients will be accrued for this study within 4 years
Primary
Determine the efficacy of adjuvant chemotherapy in terms of disease-free survival in women with radically resected loco-regional relapsed breast cancer
Secondary
Determine the systemic disease-free and overall survival of patients treated with this regimen
Determine the sites of recurrence incidence of second non-breast malignancies and causes of death without relapse of breast cancer in patients treated with this regimen
Determine the quality of life of patients treated with this regimen QOL portion closed 111308
OUTLINE This is a randomized multicenter study Patients are stratified according to prior chemotherapy yes vs no estrogen receptor ER positive andor progesterone receptor PR positive yes vs no and location of recurrence breast vs mastectomy scarchest wall vs regional lymph nodes Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive radiotherapy within 6 months after surgery
Arm II Within 10 weeks after surgery patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator Patients also receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy
NOTE Patients with clear margins R0 who received prior adjuvant radiotherapy are not required to receive further radiotherapy
Patients with ER andor PR positive tumors also receive standard hormonal therapy
Quality of life is assessed at baseline and at 9 and 12 months QOL portion closed 111308
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 265 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| IBCSG-27-02 | OTHER | None | None |
| BIG-1-02 | OTHER | None | None |
| EU-20320 | None | None | None |
| NSABP-B-37 | None | None | None |
| 2005-001484-64 | EUDRACT_NUMBER | Breast International Group | None |