Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT06080620
Status:
RECRUITING
Last Update Posted:
2023-10-12
First Post:
2023-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Choice of Treatment Methods and Efficacy of LABC
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
Treatment Selection and Efficacy of Locally Advanced Breast cancer-a Prospective Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2023-10
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 compare the therapeutic effects of chemotherapy followed by surgery and surgery followed by chemotherapy in patients with locally advanced breast cancer（LABC). Patients with LABC will be randomly divided into two groups, each receiving chemotherapy followed by surgery or surgery followed by chemotherapy. The main comparison was between the disease-free survival (DFS) of two groups of patients, with the secondary study endpoint being overall survival (OS); Five year survival; Local recurrence or distant metastasis rate.
Detailed Description:
Local advanced breast cancer was enrolled in the Department of Breast Surgery of Peking Union Medical College Hospital and Beijing Cooperation Hospital according to the criteria for patient inclusion. It is estimated that 50 patients will be enrolled. Randomly divide patients into two groups. The plan for Group A (experimental group, 25 cases) is "surgery+systematic treatment"; The plan for Group B (control group, 25 cases) is "neoadjuvant therapy+surgery+systematic treatment". Based on the previously obtained patient personal information, treatment related information, tumor tissue/blood sample test results, statistical analysis was conducted to explore the impact of different treatment strategies for locally advanced breast cancer on the survival and prognosis of patients.
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?:
None
Is an FDA AA801 Violation?: