Back to resultsThe Choice of Treatment Methods and Efficacy of LABC
Primary Purpose
Locally Advanced Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Modified radical mastectomy for breast cancer
neoadjuvant therapy
Systematic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Breast Cancer focused on measuring Locally Advanced Breast Cancer, prognosis
Eligibility Criteria
Inclusion Criteria: 18-70 year old female Patients with locally advanced breast cancer (stage IIIb - IIIc) first diagnosed; Clinical diagnosis of breast cancer, or puncture pathology suggests breast cancer; 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; Accept treatment plans including surgery, radiotherapy, and chemotherapy; Volunteer to participate in clinical research and sign an informed consent form; 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: Patients under 18 years old or over 70 years old; Those who have received breast cancer related surgery, radiotherapy or chemotherapy; Those who are not expected to receive surgery, radiotherapy or chemotherapy related to breast cancer History of other malignant tumors; Pregnant or lactating women; Accompanying active infection and fever; 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.
Sites / Locations
- Ying XuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Surgery+systematic treatment
Neoadjuvant therapy+surgery+systematic treatment
Outcomes
Primary Outcome Measures
DFS
Disease-free survival of patients with locally advanced breast cancer
Secondary Outcome Measures
OS
Overall survival of patients with locally advanced breast cancer
Five year survival rate
Five year survival rate of patients with locally advanced breast cancer
Local recurrence or distant metastasis rate
Local recurrence or distant metastasis rate of patients with locally advanced breast cancer
Full Information
NCT ID
NCT06080620
First Posted
September 21, 2023
Last Updated
October 6, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06080620
Brief Title
The Choice of Treatment Methods and Efficacy of LABC
Official Title
Treatment Selection and Efficacy of Locally Advanced Breast cancer-a Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2023 (Anticipated)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Breast Cancer
Keywords
Locally Advanced Breast Cancer, prognosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
The plan for Group A (experimental group) is "surgery+systematic treatment"; The plan for Group B (control group) is "neoadjuvant therapy+surgery+systematic treatment".
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Surgery+systematic treatment
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Neoadjuvant therapy+surgery+systematic treatment
Intervention Type
Procedure
Intervention Name(s)
Modified radical mastectomy for breast cancer
Intervention Description
Modified radical mastectomy for breast cancer
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Description
neoadjuvant chemotherapy（Drugs：" Doxorubicin""Paclitaxel""Albumin paclitaxel""Cyclophosphamide"）, endocrine therapy（Drugs："Toremifen""Zoladex""Aromatase inhibitors"）, targeted therapy（Drugs："trastuzumab""Pertuzumab"）
Intervention Type
Procedure
Intervention Name(s)
Systematic treatment
Intervention Description
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"）
Primary Outcome Measure Information:
Title
DFS
Description
Disease-free survival of patients with locally advanced breast cancer
Time Frame
1 year；3 years；5 years
Secondary Outcome Measure Information:
Title
OS
Description
Overall survival of patients with locally advanced breast cancer
Time Frame
1 year；3 years；5 years
Title
Five year survival rate
Description
Five year survival rate of patients with locally advanced breast cancer
Time Frame
1 year；3 years；5 years
Title
Local recurrence or distant metastasis rate
Description
Local recurrence or distant metastasis rate of patients with locally advanced breast cancer
Time Frame
1 year；3 years；5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-70 year old female
Patients with locally advanced breast cancer (stage IIIb - IIIc) first diagnosed;
Clinical diagnosis of breast cancer, or puncture pathology suggests breast cancer;
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;
Accept treatment plans including surgery, radiotherapy, and chemotherapy;
Volunteer to participate in clinical research and sign an informed consent form;
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:
Patients under 18 years old or over 70 years old;
Those who have received breast cancer related surgery, radiotherapy or chemotherapy;
Those who are not expected to receive surgery, radiotherapy or chemotherapy related to breast cancer
History of other malignant tumors;
Pregnant or lactating women;
Accompanying active infection and fever;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Xu
Phone
+861069158721
Email
xuying@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Lin
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ying Xu
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Xu
Phone
+861069158721
12. IPD Sharing Statement
Learn more about this trial
The Choice of Treatment Methods and Efficacy of LABC
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