Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003013
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Surgery in Treating Women With Breast Cancer
Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
European Cooperative Study of Chemotherapy and Surgery Comparing Adjuvant Doxorubicin Followed by CMF vs Adjuvant DoxorubicinPaclitaxel Followed by CMF vs Primary DoxorubicinPaclitaxel Followed by CMF in Women With Operable Breast Cancer and T2 cm
Status:
COMPLETED
Status Verified Date:
2000-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining surgery with chemotherapy may kill more tumor cells It is not yet known which treatment regimen is more effective for breast cancer
PURPOSE Randomized phase III trial to study the effectiveness of chemotherapy plus surgery in treating women who have breast cancer
PURPOSE Randomized phase III trial to study the effectiveness of chemotherapy plus surgery in treating women who have breast cancer
Detailed Description:
OBJECTIVES
Evaluate whether 8 courses of primary chemotherapy before adequate surgery of breast tumor and locoregional radiotherapy plus tamoxifen for 5 years improves the disease-free and overall survival in women with operable breast carcinoma and tumor at diagnosis greater than 2 cm in diameter
Assess whether in the postoperative arms the addition of paclitaxel to doxorubicin before CMF cyclophosphamide methotrexate and fluorouracil improves disease-free and overall survival in these patients
Define the incidence of pathologic complete response CR induced by 8 courses of primary chemotherapy containing paclitaxel
Assess whether a pathologic CR is an independent predictor of disease-free and overall survival
Evaluate the effects of primary chemotherapy on the rate and quality of breast conserving surgery
OUTLINE This is a randomized multicenter study Patients are stratified by center tumor diameter at mammography nuclear or histological grade and estrogenprogesterone receptor status Patients are randomized to one of three treatment arms
Arm I Patients receive doxorubicin IV over 15 minutes once every 3 weeks for 4 courses Beginning 21 days after the last administration of doxorubicin patients receive cyclophosphamide IV methotrexate IV and fluorouracil IV on days 1 and 8 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
Arms II and III Patients receive doxorubicin IV over 15 minutes and paclitaxel IV over 3 hours once every 3 weeks for 4 courses Beginning 21 days after the last administration of doxorubicin and paclitaxel patients receive cyclophosphamide IV methotrexate IV and fluorouracil IV on days 1 and 8 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
All patients have either mastectomy or breast conserving surgery patients with unclear surgical margins may have second surgery re-resection or total mastectomy or radiotherapy Lymph node axillary dissection is performed up to at least the second level For patients in the 2 adjuvant arms arms I and II adjuvant chemotherapy starts by day 21 after surgery For patients in the primary chemotherapy arm arm III surgery is performed by day 28 after the last course of chemotherapy or at resolution of all possible hematological or infective complications
At the end of the combined surgery plus chemotherapy approach ie after the last course of CMF arms I and II or after surgery arm III patients enrolled after June 30 2000 with estrogen or progesterone receptor positive disease receive oral tamoxifen daily for 5 years
All patients who have breast conserving surgery receive postoperative irradiation within 4 weeks after completing chemotherapy and surgery ie within 4 weeks from last dose of adjuvant chemotherapy arms I and II or from surgery arm III All patients who have mastectomy and have pT4 disease must receive irradiation to the chest wall
Patients are followed at 6 12 18 and 24 months and then annually thereafter
PROJECTED ACCRUAL A total of 450 patients per arm will be accrued for this study within 5 years
Evaluate whether 8 courses of primary chemotherapy before adequate surgery of breast tumor and locoregional radiotherapy plus tamoxifen for 5 years improves the disease-free and overall survival in women with operable breast carcinoma and tumor at diagnosis greater than 2 cm in diameter
Assess whether in the postoperative arms the addition of paclitaxel to doxorubicin before CMF cyclophosphamide methotrexate and fluorouracil improves disease-free and overall survival in these patients
Define the incidence of pathologic complete response CR induced by 8 courses of primary chemotherapy containing paclitaxel
Assess whether a pathologic CR is an independent predictor of disease-free and overall survival
Evaluate the effects of primary chemotherapy on the rate and quality of breast conserving surgery
OUTLINE This is a randomized multicenter study Patients are stratified by center tumor diameter at mammography nuclear or histological grade and estrogenprogesterone receptor status Patients are randomized to one of three treatment arms
Arm I Patients receive doxorubicin IV over 15 minutes once every 3 weeks for 4 courses Beginning 21 days after the last administration of doxorubicin patients receive cyclophosphamide IV methotrexate IV and fluorouracil IV on days 1 and 8 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
Arms II and III Patients receive doxorubicin IV over 15 minutes and paclitaxel IV over 3 hours once every 3 weeks for 4 courses Beginning 21 days after the last administration of doxorubicin and paclitaxel patients receive cyclophosphamide IV methotrexate IV and fluorouracil IV on days 1 and 8 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
All patients have either mastectomy or breast conserving surgery patients with unclear surgical margins may have second surgery re-resection or total mastectomy or radiotherapy Lymph node axillary dissection is performed up to at least the second level For patients in the 2 adjuvant arms arms I and II adjuvant chemotherapy starts by day 21 after surgery For patients in the primary chemotherapy arm arm III surgery is performed by day 28 after the last course of chemotherapy or at resolution of all possible hematological or infective complications
At the end of the combined surgery plus chemotherapy approach ie after the last course of CMF arms I and II or after surgery arm III patients enrolled after June 30 2000 with estrogen or progesterone receptor positive disease receive oral tamoxifen daily for 5 years
All patients who have breast conserving surgery receive postoperative irradiation within 4 weeks after completing chemotherapy and surgery ie within 4 weeks from last dose of adjuvant chemotherapy arms I and II or from surgery arm III All patients who have mastectomy and have pT4 disease must receive irradiation to the chest wall
Patients are followed at 6 12 18 and 24 months and then annually thereafter
PROJECTED ACCRUAL A total of 450 patients per arm will be accrued for this study within 5 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-97001 | None | None | None |
| INT-2396 | None | None | None |