The Choice of Treatment Methods and Efficacy of LABC

Locally Advanced Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06080620
• Other study ID #: PUMCH-LABC study
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2023
• Est. completion date: August 1, 2026

Study information

• Verified date: October 2023
• Source: Peking Union Medical College Hospital
• Contact: Ying Xu
• Phone: +861069158721
• Email: xuying[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Locally Advanced Breast Cancer

Intervention

Procedure:
• Modified radical mastectomy for breast cancer
Modified radical mastectomy for breast cancer
• neoadjuvant therapy
neoadjuvant chemotherapy(Drugs:" Doxorubicin""Paclitaxel""Albumin paclitaxel""Cyclophosphamide"), endocrine therapy(Drugs:"Toremifen""Zoladex""Aromatase inhibitors"), targeted therapy(Drugs:"trastuzumab""Pertuzumab")
• 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")

Locations

Country	Name	City	State
China	Ying Xu	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS	Disease-free survival of patients with locally advanced breast cancer	1 year;3 years;5 years
Secondary	OS	Overall survival of patients with locally advanced breast cancer	1 year;3 years;5 years
Secondary	Five year survival rate	Five year survival rate of patients with locally advanced breast cancer	1 year;3 years;5 years
Secondary	Local recurrence or distant metastasis rate	Local recurrence or distant metastasis rate of patients with locally advanced breast cancer	1 year;3 years;5 years