To evaluate the efficacy and safety of nab-paclitaxel combined with carboplatin for Chinese patients with triple-negative and HER2-positive breast cancer in the neoadjuvant setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
125 mg/m² weekly, infusion, 3 weeks on 1 week off, applicated for four cycles.
AUC 2, weekly, 3 weeks on 1 week off, applicated for 4 cycles
In case of HER2-positive, patients receive Herceptin weekly during all cycles.
Ruijin Hospital
Shanghai, China
RECRUITINGPathological complete response (ypT0/is ypN0) rate
Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.
Time frame: 16 weeks (at the time of definitive surgery)
Invasive disease-free survival (IDFS)
IDFS is defined as the time period between registration and first event (ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, second primary nonbreast invasive cancer)
Time frame: 5 years
Distant disease-free survival (DDFS)
DDFS is defined as the time period between registration and first event (distant recurrence, death attributable to any cause, second primary nonbreast invasive cancer)
Time frame: 5 years
Objective response rate (ORR)
ORR includes all patients whose cancer has a partial or complete response according to RECIST 1.1
Time frame: 16 weeks (at the time of definitive surgery)
Breast conservation rate
To determine the breast conservation rate after neoadjuvant treatment.
Time frame: 16 weeks (at the time of definitive surgery)
Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped
Descriptive statistics will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.
Time frame: during treatment (16 weeks)
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