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Trial Title:
The Choice of Treatment Methods and Efficacy of LABC
NCT ID:
NCT06080620
Condition:
Locally Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Locally Advanced Breast Cancer
prognosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Intervention 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".
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Modified radical mastectomy for breast cancer
Description:
Modified radical mastectomy for breast cancer
Arm group label:
Group A
Arm group label:
Group B
Intervention type:
Procedure
Intervention name:
neoadjuvant therapy
Description:
neoadjuvant chemotherapy（Drugs：" Doxorubicin""Paclitaxel""Albumin
paclitaxel""Cyclophosphamide"）, endocrine therapy（Drugs："Toremifen""Zoladex""Aromatase
inhibitors"）, targeted therapy（Drugs："trastuzumab""Pertuzumab"）
Arm group label:
Group B
Intervention type:
Procedure
Intervention name:
Systematic treatment
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"）
Arm group label:
Group A
Arm group label:
Group B
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ying Xu
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Xu
Phone:
+861069158721
Start date:
October 8, 2023
Completion date:
August 1, 2026
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06080620
