Ignite Creation Date:
2024-05-06 @ 2:30 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04337658
Status:
NOT_YET_RECRUITING
Last Update Posted:
2020-04-08
First Post:
2020-01-11
Brief Title:
Anti-HER2 Therapy FulvestrantCapecitabine in Women With HR HER2 Non-visceral Metastases Stage IV Breast Cancer
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
A Phase 3 Randomized Multicenter Open-Label Study to Compare the Efficacy and Safety of Anti-HER2 Therapy Plus Fulvestrant or Capecitabine in First-line Treatment of Women With HR HER2 Non-visceral Metastases Stage IV Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2020-04
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:
FAVOR
Brief Summary:
The purpose of this study is to evaluate the effectiveness of anti-HER2 therapy plus Fulvestrant or Capecitabine in women with hormone receptor positive HR human epidermal growth factor receptor 2 positive HER2 non-visceral metastases stage IV breast cancer
Detailed Description:
This is a prospective randomized 2-arm multicenter study to compare the safety and efficiency of anti-HER2 therapy Trastuzumab Pertuzumab plus fulvestrant versus anti-HER2 therapy Trastuzumab Pertuzumab plus capecitabine in women with hormone receptor positive HR human epidermal growth factor receptor 2 positive HER2 non-visceral metastases stage IV breast cancer Subjects will be randomized into one of two treatment arms Arm A subjects will receive the anti-HER2 therapy plus fulvestrant Arm B subjects will receive the anti-HER2 therapy plus capecitabine The use of Pertuzumab depends on patients choices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None