Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114816
Status:
COMPLETED
Last Update Posted:
2007-05-21
First Post:
2005-06-17
Brief Title:
Docetaxel Followed by CEF Cyclophosphamide Epirubicin and 5-Fluorouracil Compared to Docetaxel and Capecitabine Followed by CEX Cyclophosphamide Epirubicin and Capecitabine as Adjuvant Treatment for Breast Cancer
Sponsor:
Finnish Breast Cancer Group
Organization:
Finnish Breast Cancer Group
Study Overview
Official Title:
A Randomized Phase III Study Comparing Docetaxel Followed by Cyclophosphamide Epirubicin and 5-FU to Docetaxel With Capecitabine Followed by Cyclophosphamide Epirubicin and Capecitabine as Adjuvant Treatment for Early Breast Cancer
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:
This study compares two chemotherapy regimens as adjuvant treatment for breast cancer The study participants are randomly allocated to receive either 3 cycles of docetaxel followed by 3 cycles of CEF cyclophosphamide epirubicin and 5-fluorouracil or to receive 3 cycles of docetaxel plus capecitabine followed by 3 cycles of CEX cyclophosphamide epirubicin and capecitabine The study participants are required to to have a medium to high risk for breast cancer recurrence The primary aim of the study is to investigate whether addition of capecitabine to a standard taxaneanthracycline regimen will influence recurrence-free survival
Detailed Description:
This is an open-label two-arm randomized multi-center phase III trial to compare efficacy and safety of a taxane-anthracycline regimen to a taxane-anthracycline-capecitabine regimen as adjuvant treatment of early breast cancer with an intermediate-to-high risk of cancer recurrence
Patients diagnosed with early breast cancer with an estimated risk of 25 or greater for distant recurrence within 5 years from the diagnosis will be randomly allocated to one of the following 2 arms 11
Arm A -- 3 cycles of docetaxel 80 mgm² intravenous iv repeated on day d 22 followed by 3 cycles of CEF cyclophosphamide 600 mgm2 iv epirubicin 75mgm² iv 5-fluorouracil 600 mgm2 iv repeated on d 22
Arm B -- 3 cycles of TX docetaxel 60 mgm² iv capecitabine twice daily 900 mgm² given orally on days 1-15 of the cycle cycle repeated on d 22 followed by 3 cycles of CEX cyclophosphamide 600 mgm2 iv epirubicin 75mgm² iv capecitabine twice daily 900 mgm² on days 1-15 of the cycle cycle repeated on d 22
Locoregional radiotherapy is given according to the institutional practice after completing adjuvant chemotherapy Tx3CEFx3 or TXx3CEXx3
All patients with ER andor PgR positive disease will receive adjuvant endocrine therapy This will consist of 1 mg po anastrozole ArimidexR given for 60 months in women who were post-menopausal prior to chemotherapy no menstrual periods for 6 months or of tamoxifen 20 mg po for 60 months in women who were pre-menopausal prior to chemotherapy
Use of trastuzumab is allowed in HER-2 positive disease
Patients will be followed up for 5 years post-randomization
Patients diagnosed with early breast cancer with an estimated risk of 25 or greater for distant recurrence within 5 years from the diagnosis will be randomly allocated to one of the following 2 arms 11
Arm A -- 3 cycles of docetaxel 80 mgm² intravenous iv repeated on day d 22 followed by 3 cycles of CEF cyclophosphamide 600 mgm2 iv epirubicin 75mgm² iv 5-fluorouracil 600 mgm2 iv repeated on d 22
Arm B -- 3 cycles of TX docetaxel 60 mgm² iv capecitabine twice daily 900 mgm² given orally on days 1-15 of the cycle cycle repeated on d 22 followed by 3 cycles of CEX cyclophosphamide 600 mgm2 iv epirubicin 75mgm² iv capecitabine twice daily 900 mgm² on days 1-15 of the cycle cycle repeated on d 22
Locoregional radiotherapy is given according to the institutional practice after completing adjuvant chemotherapy Tx3CEFx3 or TXx3CEXx3
All patients with ER andor PgR positive disease will receive adjuvant endocrine therapy This will consist of 1 mg po anastrozole ArimidexR given for 60 months in women who were post-menopausal prior to chemotherapy no menstrual periods for 6 months or of tamoxifen 20 mg po for 60 months in women who were pre-menopausal prior to chemotherapy
Use of trastuzumab is allowed in HER-2 positive disease
Patients will be followed up for 5 years post-randomization
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 |
|---|---|---|---|
| Roche protocol number MO17728 | None | None | None |