About this trial
This is a prospective, multi-center, real-world study designed to evaluate the efficacy and safety of albumin-bound paclitaxel versus paclitaxel or docetaxel in adjuvant treatment of breast cancer.
Eligibility criteria
Qualifiers
Female patients aged from 18 to 70 years old;
Histologically confirmed as invasive breast cancer;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Participants achieved complete tumor resection by radical mastectomy, modified radical mastectomy or breast-conserving surgery with negative margins;
Disqualifiers
In the past and present, participants with severe cardiac disease or discomfort , including but not limited: 1) High-risk uncontrolled arrhythmia, atrial tachycardia (heart rate > 100/min in resting state), significant ventricular arrhythmia (ventricular arrhythmia) or higher atrioventricular block (second-degree type 2 [Mobitz 2] atrioventricular block or third-degree atrioventricular block); 2) Angina pectoris requiring anti-angina medication; 3) Clinically significant valvular heart disease; 4) ECG showing transmural myocardial infarction; 5) Uncontrolled hypertension (eg systolic blood pressure > 180mm Hg or diastolic blood pressure > 100mmHg); 6) Myocardial infarction; 7) Congestive heart failure;
Participants who have received prior any systematic treatment for breast cancer;
Participants with bilateral invasive breast cancer;
Breast cancer with distant metastasis;
Trial design
Treatments tested in this trial
- doxorubicin
- epirubicin
- pirarubicin
- cyclophosphamide
- albumin-bound paclitaxel
- paclitaxel
- docetaxel
Treatment groups
Sponsors and collaborators
Chinese Academy of Medical Sciences
Lead sponsor
CSPC Ouyi Pharmaceutical Co., Ltd.
Collaborator