Ignite Creation Date:
2024-05-05 @ 11:32 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01352091
Status:
UNKNOWN
Last Update Posted:
2011-05-11
First Post:
2011-05-10
Brief Title:
Adjuvant AI Combined With Zoladex
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Randomized Open Label Study Comparing the Efficacy of Zoladex Combined With Arimidex for 3-2 Years After Selective Estrogen Receptor Modulators SERMs as an Adjuvant Therapy for 2-3 Years Versus Continuing Tamoxifen up to 5 Years for Premenopausal Early Breast Cancer Patients With Hormone Receptor Positive Lymph Node Positive or Tumor 4cm
Status:
UNKNOWN
Status Verified Date:
2008-04
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:
The present study is a randomized open-label -phase III study that aims to compare the efficacy of Zoladex combined with Aromidex for 3-2 years after SERMs tamoxifen and Fareston as an adjuvant therapy for 2-3 years with the efficacy of tamoxifen up to 5 years for premenopausal breast cancer women with hormone receptor positive lymph node positive or tumor 4cm According to St Gallens guideline hormone receptor positive was defined as endocrine responsive and endocrine response uncertain categories table 3-1 and only those with ER or PR expression undetectable were considered as HR negative The pathological evaluation of axillary lymph node could be done by sentinel node biopsy SNB when axillary nodes were clinically impalpable accompanied with axillary lymph node dissection ALND or directly through ALND when axillary nodes appeared to be positive in clinical examination Based on the operating standard of local medical institution identifying the numbers of lymph nodes to do the pathological evaluation and to do the dissection of I- or II-station nodes accurately
Detailed Description:
None
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