The Choice of Treatment Methods and Efficacy of LABC
Treatment Selection and Efficacy of Locally Advanced Breast cancer-a Prospective Randomized Controlled Study
Peking Union Medical College Hospital
50 participants
Oct 8, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria7
- 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.
Interventions
Modified radical mastectomy for breast cancer
neoadjuvant chemotherapy（Drugs：" Doxorubicin""Paclitaxel""Albumin paclitaxel""Cyclophosphamide"）, endocrine therapy（Drugs："Toremifen""Zoladex""Aromatase inhibitors"）, targeted therapy（Drugs："trastuzumab""Pertuzumab"）
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(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06080620