This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial designed to compare the efficacy and safety of neoadjuvant chemotherapy based on SNF classification with or without precision medicine agents in previously untreated patients with early-stage or locally advanced HR+/HER2- breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
404
The backbone is chemotherapy which will be used in the control group. The precision group will add targeted therapy agents which were determined according to SNF classification: the SNF2 subtype add adebrelimab combined with famitinib, the SNF3 subtype receives fluzoparib, and the SNF4 subtype receives apatinib.
Chemotherapy : weely nab-P \* 12- EC \* 4
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGPathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 ((i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery)
pCR rate after neoadjuvant treatment, defined as the proportion of participants who have no evidence by H\&E staining of residual invasive disease in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by investigator assessment following completion of neoadjuvant therapy.
Time frame: Up to approximately 1 year
Event-free survival (EFS) rate at 12, 24, 36-month
EFS is defined as time from date of randomisation until disease progression precluding initial surgery, invasive disease recurrence (local, regional, distant, or contralateral), or death from any cause.
Time frame: Up to approximately 3 years
Invasive disease-free survival (IDFS) rate at 12, 24, 36-month
IDFS is defined as time from surgery until invasive disease recurrence (local, regional, distant, or contralateral), or death from any cause.
Time frame: Up to approximately 3 years
Overall Survival (OS)
OS is defined as the time from randomisation until the date of death due to any cause.
Time frame: Approximately 5 years
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR) based on BICR and investigator assessment using RECIST 1.1.
Time frame: Approximately 1 year
Safety including adverse events (AEs), severe adverse events (SAEs) and adverse events of special interest (AESI).
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Incidence of AEs, SAE, AESIs (interstitial lung disease, LVEF decrease), AEs resulting in study intervention interruption and discontinuation, etc.
Time frame: Up to approximately 1.5 years