The investigators hypothesize that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer. In patients with some sub-type advanced breast cancer, neo-adjuvant chemotherapy combined with endocrine therapy may improve the pathological remission rate. Premenopausal patients with triple negative breast caner and hormonal receptor positve breast cancer patients will be randominzed to have neoadjuvant chemotherapy combined with endocrine therapy or not.
In this trial, patients with ER and or PR positive breast cancer will be separately randomized to have chemotherapy or chemotherapy combined with endocrine therapy according to their menstrual status. Letrozole for the postmenopausal women and ovarian function suppression for the premenopausal women. Patients with triple negative breast cancer will be randomized to have neoadjuvant chemotherapy combined with ovarian function suppression if she is premenopausal. Postermenopausal patients with triple negative breast caner will only have neoadjuvant chemotherapy. Patients with Her2 overexpression can obtain anti-Her2 target therapy. This study has been amended to a 1:2 ratio to control and neoadjuvant chemotherapy combination of endocrine therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Department of Thyroid and Breast Gland Surgery,Shenzhen Longgang Central Hospital
Shenzhen, Guangdong, China
HanDan Central Hospital
Handan, Hebei, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Department of Thyroid and Breast Surgery, The Affiliated Hospital of Inner Mongolia Medical Collage
Hohhot, Inner Mongolia, China
The second people's hospital of Kunshan city
Kunshan, Jiangsu, China
Department of Medical Oncology, General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China
Yueyang hospital of integrated traditional Chinese and Western medine
Shanghai, Shanghai Municipality, China
Armed Police Corps Hospital of Shanghai
Shanghai, Shanghai Municipality, China
...and 2 more locations
pathological complete remission rate
Pathological complete remission is defined as no invasive cancer in breast and axillary nodes.
Time frame: after 4 months preoperative treatment
Number of Participants With Drug Related Treatment Adverse Events
Adverse events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state.
Time frame: 4 months during neoadjuvant therapy
Clinical and imaging response
To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment
Time frame: 4 months during treatment
disease free survival (DFS)
DFS is defined as the time in months from randomization until first occurrence of locoregional recurrence, distant metastasis, contralateral breast cancer, second primary tumor, or death from any cause.
Time frame: 5 years
regional recurrence free survival (RRFS)
RRFS is defined as the time period between registration and first event
Time frame: 5 years
local recurrence free survival (LRFS)
LRFS is defined as the time period between registration and first event
Time frame: 5 years
overall survival (OS)
OS is defined as the time period between registration and first event
Time frame: 5 years
distant-disease- free survival (DDFS)
DDFS is defined as the time period between registration and first event
Time frame: 5 years
rate of tumor remission （RTR）
RTR is defined as the proportion of tumor remission per unit time
Time frame: after 2 cycles and 4 cycles during neoadjuvant therapy
serum markers
Changes in the angiogenic serum markers(mirRNA, lncRNA, cirRNA), measured at diagnosis and surgery
Time frame: Pre-treatment and/or surgical
molecular markers
Pre-treatment and surgical expression of molecular markers （LHRHa receptor, EGFR，PD-L1)
Time frame: Pre-treatment and/or surgical
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.