NCT06080620

The Choice of Treatment Methods and Efficacy of LABC

Treatment Selection and Efficacy of Locally Advanced Breast cancer-a Prospective Randomized Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Modified radical mastectomy for breast cancer	Modified radical mastectomy for breast cancer
PROCEDURE	neoadjuvant therapy	neoadjuvant chemotherapy（Drugs：" Doxorubicin""Paclitaxel""Albumin paclitaxel""Cyclophosphamide"）, endocrine therapy（Drugs："Toremifen""Zoladex""Aromatase inhibitors"）, targeted therapy（Drugs："trastuzumab""Pertuzumab"）
PROCEDURE	Systematic treatment	chemotherapyDrugs：" Doxorubicin""Paclitaxel""Albumin paclitaxel""Cyclophosphamide"）, endocrine therapy（Drugs："Toremifen""Zoladex""Aromatase inhibitors"）, targeted therapy（Drugs："trastuzumab""Pertuzumab"），radiotherapy（"Yikeda Versa HD linear accelerator""Varian Trilogy linear accelerator"）

Timeline

• Start date: 2023-10-08
• Primary completion: 2025-10-01
• Completion: 2026-08-01
• First posted: 2023-10-12
• Last updated: 2023-10-12

Locations

1 site across 1 country: China