Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070278
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2003-10-03
Brief Title:
Neoadjuvant Epirubicin Cyclophosphamide and Paclitaxel With or Without Gemcitabine in Treating Women Who Are Undergoing Surgery for Early Breast Cancer
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Randomized Neoadjuvant Study of Sequential EpirubicinCyclophosphamide and Paclitaxel - Gemcitabine in Poor Risk Early Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2009-01
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 epirubicin cyclophosphamide paclitaxel and gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed during surgery It is not yet known which combination chemotherapy regimen is more effective in treating early breast cancer
PURPOSE This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating women who are undergoing surgery for early invasive breast cancer
PURPOSE This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating women who are undergoing surgery for early invasive breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare the complete pathological response rate in women with poor-risk early breast cancer treated with neoadjuvant sequential epirubicin cyclophosphamide and paclitaxel with vs without gemcitabine
Secondary
Compare the disease-free and overall survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the effect of these regimens on prognostic factors in these patients
Correlate molecular profiles specific gene mutations and genomic and gene expression changes with clinical outcome in these patients
Compare the quality of life of patients treated with these regimens
Determine the health economics associated with this study
OUTLINE This is a randomized multicenter study Patients are stratified according to estrogen-receptor status negative vs greater than 10 positive cells HER-2 status positive vs negative tumor size 30-50 mm vs greater than 50 mm and clinical involvement of axillary nodes yes vs no Patients are randomized to 1 of 4 treatment arms
Neoadjuvant sequential chemotherapy
Arm I Patients receive epirubicin IV and cyclophosphamide IV on day 1 Treatment repeats every 21 days for 4 courses Patients then receive paclitaxel IV over 3 hours on day 1 Treatment repeats every 21 days for 4 courses
Arm II Patients receive paclitaxel as in arm I followed by epirubicin and cyclophosphamide as in arm I
Arm III Patients receive epirubicin and cyclophosphamide as in arm I followed by paclitaxel as in arm I and gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for 4 courses
Arm IV Patients receive paclitaxel as in arm I and gemcitabine as in arm III followed by epirubicin and cyclophosphamide as in arm I
Surgery After completion of neoadjuvant chemotherapy patients in all arms undergo definitive surgery
Tumor tissue is removed from a subset of patients during serial biopsies Molecular and genetic profiling mutation analysis and comparative genomic analysis is performed on the tissue samples
Quality of life is assessed at baseline after 4 courses of chemotherapy after the completion of chemotherapy after surgery and then every 6 months for 2 years
Patients are followed every 2 months for 2 years and then every 3 months for 3 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 800 patients 200 per treatment arm will be accrued for this study
Primary
Compare the complete pathological response rate in women with poor-risk early breast cancer treated with neoadjuvant sequential epirubicin cyclophosphamide and paclitaxel with vs without gemcitabine
Secondary
Compare the disease-free and overall survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the effect of these regimens on prognostic factors in these patients
Correlate molecular profiles specific gene mutations and genomic and gene expression changes with clinical outcome in these patients
Compare the quality of life of patients treated with these regimens
Determine the health economics associated with this study
OUTLINE This is a randomized multicenter study Patients are stratified according to estrogen-receptor status negative vs greater than 10 positive cells HER-2 status positive vs negative tumor size 30-50 mm vs greater than 50 mm and clinical involvement of axillary nodes yes vs no Patients are randomized to 1 of 4 treatment arms
Neoadjuvant sequential chemotherapy
Arm I Patients receive epirubicin IV and cyclophosphamide IV on day 1 Treatment repeats every 21 days for 4 courses Patients then receive paclitaxel IV over 3 hours on day 1 Treatment repeats every 21 days for 4 courses
Arm II Patients receive paclitaxel as in arm I followed by epirubicin and cyclophosphamide as in arm I
Arm III Patients receive epirubicin and cyclophosphamide as in arm I followed by paclitaxel as in arm I and gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for 4 courses
Arm IV Patients receive paclitaxel as in arm I and gemcitabine as in arm III followed by epirubicin and cyclophosphamide as in arm I
Surgery After completion of neoadjuvant chemotherapy patients in all arms undergo definitive surgery
Tumor tissue is removed from a subset of patients during serial biopsies Molecular and genetic profiling mutation analysis and comparative genomic analysis is performed on the tissue samples
Quality of life is assessed at baseline after 4 courses of chemotherapy after the completion of chemotherapy after surgery and then every 6 months for 2 years
Patients are followed every 2 months for 2 years and then every 3 months for 3 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 800 patients 200 per treatment arm 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 |
|---|---|---|---|
| EU-20316 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000331863 | REGISTRY | None | None |