Ignite Creation Date:
2024-05-06 @ 1:19 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03997539
Status:
UNKNOWN
Last Update Posted:
2019-06-25
First Post:
2019-06-13
Brief Title:
A Study of Pyrotinib Plus Vinorelbine in Comparison With Treatment of Physicians Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Randomized Multicenter Phase II Open-label Study of the Efficacy and Safety of Pyrotinib Vinorelbine vs Treatment of Physicians Choice in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
NOT_YET_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 purpose of this study is to identify the highest tolerable dose of pyrotinib in combination with vinorelbine and to assess the safety and efficacy of the combination in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer
The study will be conducted in two parts In the first part testing will be done on up to 12 subjects to determine the highest tolerable dose of pyrotinib and vinorelbine in patients with advanced solid tumors In the second part of the study we will compare the safety and efficacy of Pyrotinib vinorelbine vs Treatment of Physicians Choice in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based TherapyParticipants will be treated until disease progression PD unmanageable toxicity or study termination
The study will be conducted in two parts In the first part testing will be done on up to 12 subjects to determine the highest tolerable dose of pyrotinib and vinorelbine in patients with advanced solid tumors In the second part of the study we will compare the safety and efficacy of Pyrotinib vinorelbine vs Treatment of Physicians Choice in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based TherapyParticipants will be treated until disease progression PD unmanageable toxicity or study termination
Detailed Description:
None
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