The neoCARHP study was a randomized, open-label, multicenter, phase III, neoadjuvant trial. This study aimed to compare the efficacy and safety of TCHP with THP neoadjuvant setting for HER2-positive breast cancer. Patients will be randomized at a 1:1 ratio into TCHP or THP, respectively, and will be treated every 3 weeks before surgery.The primary endpoint was the percentage of pCR (ypT0/is, ypN0), which was defined as the absence of any residual invasive cancer in both the breast and axillary lymph nodes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
774
investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP)
investigator-selected taxane/trastuzumab/pertuzumab (THP)
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGpathological complete response(ypT0/is,ypN0, pCR)
defined as the absence of invasive tumor cells in breast and axilla, ypT0/is ypN0
Time frame: 18 weeks
Clinical response during neoadjuvant therapy
Clinical response during neoadjuvant therapy, according to RECIST v1.1.
Time frame: 18 weeks
The percentage of patients who underwent breast-conserving surgery
Time frame: 18 weeks
Event-free survival (EFS)
Event-free survival (EFS), defined as the time from randomization to the first report of one of the following events: 1. Disease progression (before surgery), as determined by the investigator according to RECIST v1.1. Any evidence of in situ contralateral disease will not be identified as progressive disease (PD). Any evidence of invasive contralateral disease will be considered as disease progression 2. Disease recurrence (local, regional, distant, or contralateral) after surgery. 3. Death from any cause.
Time frame: until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first.
Disease-free survival (DFS)
Disease-free survival (DFS), defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of one of the following events: 1. Disease recurrence (local, regional, distant, or contralateral) after surgery 2. Death from any cause
Time frame: until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first.
Safety Outcome Measures
The safety outcome measures for this study are the incidence, type, and severity of adverse events and serious adverse events.
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Time frame: until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first.
Overall survival, defined as the time from randomization to death from any cause.
Overall survival, defined as the time from randomization to death from any cause.
Time frame: from randomization to death from any cause.