Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488722
Status:
UNKNOWN
Last Update Posted:
2007-06-26
First Post:
2007-06-19
Brief Title:
A Prospective Single-Arm Study to Evaluate the Efficacy and Safety of Zoladex 36mg Combined With CEF Chemotherapy as Neo-Adjuvant Therapy in Hormone Responsive Premenopausal Operable Breast Cancer
Sponsor:
Tianjin Medical University
Organization:
Tianjin Medical University
Study Overview
Official Title:
A Prospective Single-Arm Study to Evaluate the Efficacy and Safety of Zoladex 36mg Combined With CEF Chemotherapy as Neo-Adjuvant Therapy in Hormone Responsive Premenopausal Operable Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
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:
It has been found that many breast cancers are hormone dependent and that hormonal therapy by estrogen suppression such as ovarian ablation tamoxifen and aromatase inhibitor has proven beneficial in both adjuvant and neoadjuvant settings Zoladex a kind of luitinizing hormone releasing hormone analogue can offer efficient estrogen suppression as well It can induce reversible amenorrhea and the clinical effect is similar to ovarian ablation Some studies have demonstrated the efficacy of zoladex in treating pre and perimenopausal hormone dependent breast cancer in both adjuvant and metastatic settings Few data is available on Zoladex in neoadjuvant treatment for breast cancer In our departments neoadjuvant CEF regimen is of general practice and a preliminary study is designed to investigate whether adding Zoladex into neoadjuvant CEF could further improve results in hormone responsive breast cancer
Detailed Description:
It has been found that many breast cancers are hormone dependent and that hormonal therapy by estrogen suppression such as ovarian ablation tamoxifen and aromatase inhibitor has proven beneficial in both adjuvant and neoadjuvant settings Zoladex a kind of luitinizing hormone releasing hormone analogue can offer efficient estrogen suppression as well It can induce reversible amenorrhea and the clinical effect is similar to ovarian ablation Some studies have demonstrated the efficacy of zoladex in treating pre and perimenopausal hormone dependent breast cancer in both adjuvant and metastatic settings Few data is available on Zoladex in neoadjuvant treatment for breast cancer In our departments neoadjuvant CEF regimen is of general practice and a preliminary study is designed to investigate whether adding Zoladex into neoadjuvant CEF could further improve results in hormone responsive breast cancer
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