Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 4:05 AM
Study NCT ID:
NCT06125834
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2023-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
Study Overview
Official Title:
Trastuzumab Emtansine (T-DM1) Treatment in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy: a Multicenter, Single-arm, Phase II Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
The goal of this clinical trial is to learn about the efficacy and safety of trastuzumab emtansine (T-DM1) in the treatment of patients with advanced HER2-positive breast cancer after TKIs or HP therapy. The main questions it aims to answer are:
* The objective response rate of patients receiving T-DM1 therapy with advanced HER2-positive breast cancer after TKIs or HP therapy.
* The adverse events and prognosis of patients with advanced HER2-positive breast cancer who receive the T-DM1 therapy.
* Changes of anti-tumor immunity during T-DM1 therapy in patients with advanced HER2-positive breast cancer.
Participants will receive T-DM1 treatment (3.6mg/kg, d1/21, IVD) until progressive diseases or intolerable adverse effects occurs.
* The objective response rate of patients receiving T-DM1 therapy with advanced HER2-positive breast cancer after TKIs or HP therapy.
* The adverse events and prognosis of patients with advanced HER2-positive breast cancer who receive the T-DM1 therapy.
* Changes of anti-tumor immunity during T-DM1 therapy in patients with advanced HER2-positive breast cancer.
Participants will receive T-DM1 treatment (3.6mg/kg, d1/21, IVD) until progressive diseases or intolerable adverse effects occurs.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: