The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as adjuvant chemotherapy is more effective for high risk, HER2 negative breast cancer .
In this trial, patients will be randomly assigned in a 2:1 ratio to receive cisplatin-based adjuvant chemotherapy and to standard adjuvant chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
762
weekly paclitaxel and cisplatin
Standard adjuvant chemotherapy recommended by guideline
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
RECRUITINGNumber of Participants With Disease-Free Survival (DFS) Events
DFS is defined as the time period between registration and first event
Time frame: up to 5 year follow up
Number of Participants With Overall Survival (OS) Events
OS is defined as the time period between registration and first event
Time frame: up to 5 year follow up
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0.
Descriptive statistics for the treatment will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped
Time frame: 5 months during adjuvant therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.