The Choice of Treatment Methods and Efficacy of LABC

NCT ID: NCT06080620

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-08
• Study Completion Date: 2026-08-01

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.

Conditions

Locally Advanced Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Surgery+systematic treatment

Group Type: EXPERIMENTAL

Modified radical mastectomy for breast cancer

Intervention Type: PROCEDURE

Modified radical mastectomy for breast cancer

Systematic treatment

Intervention Type: PROCEDURE

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"）

Group B

Neoadjuvant therapy+surgery+systematic treatment

Group Type: ACTIVE_COMPARATOR

Modified radical mastectomy for breast cancer

Intervention Type: PROCEDURE

Modified radical mastectomy for breast cancer

neoadjuvant therapy

Intervention Type: PROCEDURE

neoadjuvant chemotherapy（Drugs：" Doxorubicin""Paclitaxel""Albumin paclitaxel""Cyclophosphamide"）, endocrine therapy（Drugs："Toremifen""Zoladex""Aromatase inhibitors"）, targeted therapy（Drugs："trastuzumab""Pertuzumab"）

Systematic treatment

Intervention Type: PROCEDURE

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"）

Interventions

Modified radical mastectomy for breast cancer

Modified radical mastectomy for breast cancer

Intervention Type: PROCEDURE

neoadjuvant therapy

neoadjuvant chemotherapy（Drugs：" Doxorubicin""Paclitaxel""Albumin paclitaxel""Cyclophosphamide"）, endocrine therapy（Drugs："Toremifen""Zoladex""Aromatase inhibitors"）, targeted therapy（Drugs："trastuzumab""Pertuzumab"）

Intervention Type: 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"）

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 18-70 year old female

2. Patients with locally advanced breast cancer (stage IIIb - IIIc) first diagnosed;

3. Clinical diagnosis of breast cancer, or puncture pathology suggests breast cancer;

4. After evaluation by experienced clinical physicians, the patient's tumor has the possibility of surgical resection. Specific evaluation indicators include ultrasound assessment of the tumor not surrounding the axillary vein;

5. Accept treatment plans including surgery, radiotherapy, and chemotherapy;

6. Volunteer to participate in clinical research and sign an informed consent form;

7. Willing to undergo follow-up and complete quality of life (EQ-5D series scale and FACT-B scale) and postoperative psychological status (Anxiety/Depression Self Rating Scale) assessments;

Exclusion Criteria

1. Patients under 18 years old or over 70 years old;

2. Those who have received breast cancer related surgery, radiotherapy or chemotherapy;

3. Those who are not expected to receive surgery, radiotherapy or chemotherapy related to breast cancer

4. History of other malignant tumors;

5. Pregnant or lactating women;

6. Accompanying active infection and fever;

7. Other serious diseases that may significantly affect clinical trial compliance, such as severe cardiopulmonary dysfunction, liver and kidney dysfunction, poorly controlled diabetes and mental illness.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Lin

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

Ying Xu

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ying Xu

Role: CONTACT

xuying@pumch.cn

+861069158721

Facility Contacts

Ying Xu

Role: primary

+861069158721

Other Identifiers

PUMCH-LABC study

Identifier Type: -

Identifier Source: org_study_id