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.
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;
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;
Parallel
doxorubicin
Drugdoxorubicin 50\~60mg/m2, i.v., d1, q3w or q2w.
epirubicin
Drugepirubicin 80\~100mg/m2, i.v., d1, q3w or q2w.
pirarubicin
Drugpirarubicin 40\~50mg/m2, i.v., d1, q3w or q2w.
cyclophosphamide
Drugcyclophosphamide 600mg/m2, i.v., d1, q3w or q2w.
albumin-bound paclitaxel
Drugalbumin-bound paclitaxel 260mg/m2, i.v., d1, q3w; 260mg/m2, i.v., d1, q2w; or 125mg/m2, i.v., d1, qw.
paclitaxel
Drugpaclitaxel 175mg/m2, i.v., d1, q3w; 175mg/m2, i.v., d1, q2w; or 80mg/m2, i.v., d1, qw.
docetaxel
Drugdocetaxel 80\~100mg/m2, i.v., d1, q3w.
5-year invasive disease-free survival (IDFS) rate
Invasive disease free survival was defined as the time from enrollment until the date of first occurrence of one of the following events: invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence (including first metastasis), invasive contralateral breast cancer, second primary invasive cancer (nonbreast, not including squamous or basal cell skin cancers, or new in situ carcinomas of any site), or death from any cause. 5-year IDFS rate is thepercentage of participants with IDFS from enrollment through 5 years.
IDFS
Invasive disease free survival was defined as the time from enrollment until the date of first occurrence of one of the following events: invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence (including first metastasis), invasive contralateral breast cancer, second primary invasive cancer (nonbreast, not including squamous or basal cell skin cancers, or new in situ carcinomas of any site), or death from any cause.
overall survival (OS)
OS was defined as the time from enrollment assignment to death as a result of any cause.
3-year invasive disease-free survival (IDFS) rate
3-year IDFS rate is the percentage of participants with IDFS from enrollment through 3 years.
Incidence and severity of adverse events
Adverse events as assessed by NCI-CTCAE V5.0
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Chinese Academy of Medical Sciences
Lead sponsor
CSPC Ouyi Pharmaceutical Co., Ltd.
Collaborator
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