Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398489
Status:
UNKNOWN
Last Update Posted:
2010-11-09
First Post:
2006-11-09
Brief Title:
Docetaxel Epirubicin and Cyclophosphamide With or Without Trastuzumab in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery
Sponsor:
Technical University of Munich
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Evaluation of Response Rate to Pre-Operative Docetaxel Herceptin Study Part A and Docetaxel Study Part B in Locally Advanced Breast Cancer Patients Stratified by HER2-Status Trial - PHASE II Herceptin Docetaxel Neoadjuvant HEDON
Status:
UNKNOWN
Status Verified Date:
2008-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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 docetaxel epirubicin and cyclophosphamide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as trastuzumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Giving chemotherapy with or without monoclonal antibody therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving these treatments after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase II trial is studying how well giving docetaxel epirubicin and cyclophosphamide with or without trastuzumab works in treating women with locally advanced breast cancer that can be removed by surgery
PURPOSE This phase II trial is studying how well giving docetaxel epirubicin and cyclophosphamide with or without trastuzumab works in treating women with locally advanced breast cancer that can be removed by surgery
Detailed Description:
OBJECTIVES
Determine the efficacy of neoadjuvant therapy comprising docetaxel and trastuzumab Herceptin and adjuvant therapy comprising epirubicin hydrochloride cyclophosphamide and trastuzumab Herceptin followed by radiotherapy in women with locally advanced HER2-positive operable breast cancer
Determine the efficacy of neoadjuvant therapy with docetaxel and adjuvant therapy comprising epirubicin hydrochloride and cyclophosphamide followed by radiotherapy in women with locally advanced HER2-negative operable breast cancer
OUTLINE This is an open-label prospective multicenter study Patients are stratified according to HER2 status positive vs negative
Neoadjuvant therapy
Stratum 1 HER2-positive disease Patients receive trastuzumab IV over 30-90 minutes on days 1 8 and 15 and docetaxel IV over 60 minutes on day 1 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Stratum 2 HER2-negative disease Patients receive docetaxel IV alone as in stratum 1
Surgery All patients undergo surgery in week 19
Adjuvant therapy Beginning within 2 weeks after surgery patients receive adjuvant therapy
Stratum 1 HER2-positive disease Patients receive trastuzumab IV over 30-90 minutes on days 1 8 and 15 epirubicin hydrochloride IV over 30 minutes on day 2 and cyclophosphamide IV over 30 minutes on day 2 Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients then receive trastuzumab IV alone every 3 weeks until week 52
Stratum 2 HER2-negative disease Patients receive epirubicin hydrochloride and cyclophosphamide as in stratum 1
Radiotherapy Patients who undergo breast conserving surgery or patients who undergo mastectomy with ypN positive lymph nodes ie 4 positive lymph nodes or ypT3 tumor ie tumor size 4 cm undergo radiotherapy beginning in approximately week 31 and continuing until up to week 38
Adjuvant endocrine therapy Patients with estrogen receptor- or progesterone receptor-positive disease receive adjuvant endocrine therapy beginning in approximately week 31 Premenopausal patients 40 years of age receive goserelin for 2-3 years and tamoxifen citrate for 5 yearsPremenopausal patients 40 years of age receive tamoxifen citrate for 5 years Postmenopausal patients receive anastrozole for 5 years years
After completion of study treatment patients are followed periodically for up to 5 years
PROJECTED ACCRUAL A total of 94 patients will be accrued for this study
Determine the efficacy of neoadjuvant therapy comprising docetaxel and trastuzumab Herceptin and adjuvant therapy comprising epirubicin hydrochloride cyclophosphamide and trastuzumab Herceptin followed by radiotherapy in women with locally advanced HER2-positive operable breast cancer
Determine the efficacy of neoadjuvant therapy with docetaxel and adjuvant therapy comprising epirubicin hydrochloride and cyclophosphamide followed by radiotherapy in women with locally advanced HER2-negative operable breast cancer
OUTLINE This is an open-label prospective multicenter study Patients are stratified according to HER2 status positive vs negative
Neoadjuvant therapy
Stratum 1 HER2-positive disease Patients receive trastuzumab IV over 30-90 minutes on days 1 8 and 15 and docetaxel IV over 60 minutes on day 1 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Stratum 2 HER2-negative disease Patients receive docetaxel IV alone as in stratum 1
Surgery All patients undergo surgery in week 19
Adjuvant therapy Beginning within 2 weeks after surgery patients receive adjuvant therapy
Stratum 1 HER2-positive disease Patients receive trastuzumab IV over 30-90 minutes on days 1 8 and 15 epirubicin hydrochloride IV over 30 minutes on day 2 and cyclophosphamide IV over 30 minutes on day 2 Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients then receive trastuzumab IV alone every 3 weeks until week 52
Stratum 2 HER2-negative disease Patients receive epirubicin hydrochloride and cyclophosphamide as in stratum 1
Radiotherapy Patients who undergo breast conserving surgery or patients who undergo mastectomy with ypN positive lymph nodes ie 4 positive lymph nodes or ypT3 tumor ie tumor size 4 cm undergo radiotherapy beginning in approximately week 31 and continuing until up to week 38
Adjuvant endocrine therapy Patients with estrogen receptor- or progesterone receptor-positive disease receive adjuvant endocrine therapy beginning in approximately week 31 Premenopausal patients 40 years of age receive goserelin for 2-3 years and tamoxifen citrate for 5 yearsPremenopausal patients 40 years of age receive tamoxifen citrate for 5 years Postmenopausal patients receive anastrozole for 5 years years
After completion of study treatment patients are followed periodically for up to 5 years
PROJECTED ACCRUAL A total of 94 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-2005-000967-24 | None | None | None |
| KRDI-TUM-HED-324-PAE-0090-I | None | None | None |
| EU-20634 | None | None | None |