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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
doxorubicin 50\~60mg/m2, i.v., d1, q3w or q2w.
epirubicin 80\~100mg/m2, i.v., d1, q3w or q2w.
pirarubicin 40\~50mg/m2, i.v., d1, q3w or q2w.
Cancer Hospital, ChineseAMS
Beijing, Beijing Municipality, China
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.
Time frame: up to 60 months
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.
Time frame: up to 60 months
overall survival (OS)
OS was defined as the time from enrollment assignment to death as a result of any cause.
Time frame: up to 60 months
3-year invasive disease-free survival (IDFS) rate
3-year IDFS rate is the percentage of participants with IDFS from enrollment through 3 years.
Time frame: up to 36 months
Incidence and severity of adverse events
Adverse events as assessed by NCI-CTCAE V5.0
Time frame: up to 60 months
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cyclophosphamide 600mg/m2, i.v., d1, q3w or q2w.
albumin-bound paclitaxel 260mg/m2, i.v., d1, q3w; 260mg/m2, i.v., d1, q2w; or 125mg/m2, i.v., d1, qw.
paclitaxel 175mg/m2, i.v., d1, q3w; 175mg/m2, i.v., d1, q2w; or 80mg/m2, i.v., d1, qw.
docetaxel 80\~100mg/m2, i.v., d1, q3w.