Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
Study NCT ID:
NCT03085368
Status:
UNKNOWN
Last Update Posted:
2017-07-28
First Post:
2017-03-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial of HER-2 Positive Breast Cancer Patients Treated With Lapatinib vs Herceptin
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial of HER-2 Positive Breast Cancer Patients Treated With Lapatinib and Paclitaxel vs Herceptin and Paclitaxel With Sequential and Synchronous Anthracycline
Status:
UNKNOWN
Status Verified Date:
2017-07
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:
This is a randomized controlled trial of HER-2 positive breast cancer patients treated with lapatinib and paclitaxel vs herceptin and paclitaxel with sequential and synchronous anthracycline
Detailed Description:
This is a randomized controlled trial of HER-2 positive breast cancer patients treated with lapatinib and paclitaxel vs herceptin and paclitaxel with sequential and synchronous anthracycline. Safety and efficacy are the primary endpoint. The positive expression of HER2 was confirmed by postoperative pathology in patients with breast adenocarcinoma (IDC). Patients who had not received any chemotherapy and targeted anti HER2 therapy.
In this study, the non inferiority design method, according to the wishes of patients and signed informed consent, randomly into the group, a total of 482 patients were enrolled in the trial group: the control group =1:1. The subjects were followed up for a total of 1 years, until the disease progressed, and the toxicity was not tolerated.
We want to study 84 months. The follow-up period was 5 years (the first adjuvant treatment time to the last follow-up) or the researchers decided to end the study.
In this study, the non inferiority design method, according to the wishes of patients and signed informed consent, randomly into the group, a total of 482 patients were enrolled in the trial group: the control group =1:1. The subjects were followed up for a total of 1 years, until the disease progressed, and the toxicity was not tolerated.
We want to study 84 months. The follow-up period was 5 years (the first adjuvant treatment time to the last follow-up) or the researchers decided to end the study.
Study Oversight
Has Oversight DMC:
True
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?: