Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00288002
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2006-02-06
Brief Title:
Combination Chemotherapy With or Without Capecitabine andor Trastuzumab Before Surgery in Treating Women With Stage I Stage II or Stage III Breast Cancer
Sponsor:
German Breast Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Study Exploring the Efficacy of Capecitabine Given Concomitantly or in Sequence to EC-Doc With or Without Trastuzumab as Neoadjuvant Treatment of Primary Breast Cancer
Status:
COMPLETED
Status Verified Date:
2009-07
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 such as epirubicin cyclophosphamide docetaxel and capecitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Monoclonal antibodies such as trastuzumab can block tumor growth in different ways Some find tumor cells and kill them or carry tumor-killing substances to them Others interfere with the ability of tumor cells to grow and spread Giving combination chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving monoclonal antibodies after surgery may kill any tumor cells that remain after surgery It is not yet known whether combination chemotherapy is more effective with or without capecitabine andor trastuzumab in treating breast cancer
PURPOSE This randomized phase III trial is studying epirubicin cyclophosphamide and docetaxel to compare how well they work with or without capecitabine andor trastuzumab before surgery in treating women with stage I stage II or stage III breast cancer
PURPOSE This randomized phase III trial is studying epirubicin cyclophosphamide and docetaxel to compare how well they work with or without capecitabine andor trastuzumab before surgery in treating women with stage I stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare the pathologic complete response rates in women with stage I-III primary breast cancer treated with neoadjuvant epirubicin hydrochloride cyclophosphamide and docetaxel with versus without capecitabine followed by surgery
Compare the pathologic complete response rates in women with HER-2neu-positive tumors receiving trastuzumab Herceptin simultaneously with neoadjuvant epirubicin hydrochloride cyclophosphamide and docetaxel to women with HER-2neu-negative tumors receiving neoadjuvant chemotherapy only
Secondary
Determine the toxicity of these regimens in these patients
Determine the disease-free loco-regional and distant survival and overall survival of patients treated with these regimens
Determine the disease-free loco-regional and distant survival and overall survival of patients treated with or without trastuzumab
Determine the breast conservation rate in patients treated with these regimens
Determine the frequency of the use of sentinel node biopsy for selecting patients for neoadjuvant chemotherapy
Compare the frequency of sentinel node biopsies at surgery after neoadjuvant chemotherapy in each arm
Determine the pathologic complete response rates to each regimen in the subgroup of patients with locally advanced T4a-d N0-3 M0 breast cancer
Determine the response rate complete response partial response or no change at surgery by imaging methods and by histopathological exam in patient subgroups according to their response after four treatments with epirubicin hydrochloride and cyclophosphamide
Determine the intention for the use of neoadjuvant chemotherapy in terms of freedom from disease avoiding mastectomy improving breast conservation and gaining information about efficacy
OUTLINE This is a randomized controlled open-label multicenter study Patients are stratified according to participating site clinical response after 4 courses of epirubicin hydrochloride and cyclophosphamide complete response vs partial response vs no change HER-2neu-status negative vs 3 by immunohistochemistry IHC or positive by fluorescence in situ hybridization FISH estrogen receptor ERprogesterone receptor PR status ER or PR positive vs ER and PR negative and extent of disease T4 or N3 vs T1-3 and N0-2
All patients receive epirubicin hydrochloride IV over 30-60 minutes and cyclophosphamide IV over 60 minutes on day 1 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients are then randomized to 1 of 3 treatment arms
Arm I Patients receive docetaxel IV over 60 minutes on day 1 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive docetaxel as in arm I Patients also receive oral capecitabine twice daily on days 1-14 Treatment with docetaxel and capecitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Arm III Patients receive docetaxel as in arm I Patients then receive oral capecitabine twice daily on days 1-14 Treatment with capecitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients with HER-2neu-positive tumors also receive trastuzumab Herceptin IV over 90 minutes on day 1 of each course of chemotherapy during treatment with epirubicin hydrochloride and cyclophosphamide AND during randomized treatment
Within 2 weeks after completion of chemotherapy all patients undergo surgery Within 2 weeks after surgery patients with HER-2neu-positive tumors resume trastuzumab treatment for up to 1 year
After completion of study treatment patients are followed periodically for at least 5 years
PROJECTED ACCRUAL A total of 1500 patients will be accrued for this study
Primary
Compare the pathologic complete response rates in women with stage I-III primary breast cancer treated with neoadjuvant epirubicin hydrochloride cyclophosphamide and docetaxel with versus without capecitabine followed by surgery
Compare the pathologic complete response rates in women with HER-2neu-positive tumors receiving trastuzumab Herceptin simultaneously with neoadjuvant epirubicin hydrochloride cyclophosphamide and docetaxel to women with HER-2neu-negative tumors receiving neoadjuvant chemotherapy only
Secondary
Determine the toxicity of these regimens in these patients
Determine the disease-free loco-regional and distant survival and overall survival of patients treated with these regimens
Determine the disease-free loco-regional and distant survival and overall survival of patients treated with or without trastuzumab
Determine the breast conservation rate in patients treated with these regimens
Determine the frequency of the use of sentinel node biopsy for selecting patients for neoadjuvant chemotherapy
Compare the frequency of sentinel node biopsies at surgery after neoadjuvant chemotherapy in each arm
Determine the pathologic complete response rates to each regimen in the subgroup of patients with locally advanced T4a-d N0-3 M0 breast cancer
Determine the response rate complete response partial response or no change at surgery by imaging methods and by histopathological exam in patient subgroups according to their response after four treatments with epirubicin hydrochloride and cyclophosphamide
Determine the intention for the use of neoadjuvant chemotherapy in terms of freedom from disease avoiding mastectomy improving breast conservation and gaining information about efficacy
OUTLINE This is a randomized controlled open-label multicenter study Patients are stratified according to participating site clinical response after 4 courses of epirubicin hydrochloride and cyclophosphamide complete response vs partial response vs no change HER-2neu-status negative vs 3 by immunohistochemistry IHC or positive by fluorescence in situ hybridization FISH estrogen receptor ERprogesterone receptor PR status ER or PR positive vs ER and PR negative and extent of disease T4 or N3 vs T1-3 and N0-2
All patients receive epirubicin hydrochloride IV over 30-60 minutes and cyclophosphamide IV over 60 minutes on day 1 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients are then randomized to 1 of 3 treatment arms
Arm I Patients receive docetaxel IV over 60 minutes on day 1 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive docetaxel as in arm I Patients also receive oral capecitabine twice daily on days 1-14 Treatment with docetaxel and capecitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Arm III Patients receive docetaxel as in arm I Patients then receive oral capecitabine twice daily on days 1-14 Treatment with capecitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients with HER-2neu-positive tumors also receive trastuzumab Herceptin IV over 90 minutes on day 1 of each course of chemotherapy during treatment with epirubicin hydrochloride and cyclophosphamide AND during randomized treatment
Within 2 weeks after completion of chemotherapy all patients undergo surgery Within 2 weeks after surgery patients with HER-2neu-positive tumors resume trastuzumab treatment for up to 1 year
After completion of study treatment patients are followed periodically for at least 5 years
PROJECTED ACCRUAL A total of 1500 patients will be accrued for this study
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 |
|---|---|---|---|
| EUDRACT-2005-001546-17 | None | None | None |
| GBG-GEPARQUATTRO | None | None | None |
| GBG-40 | None | None | None |
| EU-205101 | None | None | None |
| AVENTIS-GBG-GEPARQUATTRO | None | None | None |
| ROCHE-AVENTIS-GBG-GEPARQUATTRO | None | None | None |