The Choice of Treatment Methods and Efficacy of LABC

October 6, 2023 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Ying Xu
        • Contact:
          • Ying Xu
          • Phone Number: +861069158721

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Surgery+systematic treatment
Procedure: Modified radical mastectomy for breast cancer
Modified radical mastectomy for breast cancer
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"）
Active Comparator: Group B
Neoadjuvant therapy+surgery+systematic treatment
Procedure: Modified radical mastectomy for breast cancer
Modified radical mastectomy for breast cancer
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"）
Procedure: neoadjuvant therapy
neoadjuvant chemotherapy（Drugs：" Doxorubicin""Paclitaxel""Albumin paclitaxel""Cyclophosphamide"）, endocrine therapy（Drugs："Toremifen""Zoladex""Aromatase inhibitors"）, targeted therapy（Drugs："trastuzumab""Pertuzumab"）

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS
Time Frame: 1 year；3 years；5 years
Disease-free survival of patients with locally advanced breast cancer
1 year；3 years；5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 1 year；3 years；5 years
Overall survival of patients with locally advanced breast cancer
1 year；3 years；5 years
Five year survival rate
Time Frame: 1 year；3 years；5 years
Five year survival rate of patients with locally advanced breast cancer
1 year；3 years；5 years
Local recurrence or distant metastasis rate
Time Frame: 1 year；3 years；5 years
Local recurrence or distant metastasis rate of patients with locally advanced breast cancer
1 year；3 years；5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Yan Lin, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 8, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-LABC study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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