We plan to explore the efficacy and safety of albumin-bound paclitaxel+carboplatin+Camrelizumab in neoadjuvant therapy for early TNBC patients, optimize the administration method and drug combination therapy.
This study is a single center, non blinded, randomized phase II clinical trial. A total of 64 TNBC patients are planned to be enrolled. Patients who meet the inclusion criteria will be randomly divided into two groups (Group A and Group B) at a ratio of 1:1, and stratified according to T stage and N stage. The administration regimen is as follows: Group A: albumin-bound paclitaxe (260 mg/m²,d 1)+Carboplatin (AUC=5, d 1)+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles; Group B: albumin-bound paclitaxe (125 mg/m²,d 1,8,15)+Carboplatin (AUC=5, d 1 )+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles Primary endpoint: Pathological complete response rate (pCR rate). Secondary study endpoints: Objective response rate (ORR), event free survival rate (EFS), disease-free survival (DFS), distant disease free survival (DDFS), and safety. Exploratory endpoints: Differences in efficacy and immune microenvironment under different administration methods
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
This study is a single center, non blinded, randomized phase II clinical trial. A total of 64 TNBC patients are planned to be enrolled. Patients who meet the inclusion criteria will be randomly divided into two groups at a ratio of 1:1 and stratified according to T stage and N stage. Group A: Albumin-bound paclitaxe (260 mg/m²,d 1)+Carboplatin (AUC=5, d 1)+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles;
This study is a single center, non blinded, randomized phase II clinical trial. A total of 64 TNBC patients are planned to be enrolled. Patients who meet the inclusion criteria will be randomly divided into two groups at a ratio of 1:1 and stratified according to T stage and N stage. Group B: Albumin-bound paclitaxe (125 mg/m²,d 1,8,15)+Carboplatin (AUC=5, d 1 )+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles;
Henan cancer hospital
Zhengzhou, Henan, China
RECRUITINGPathological Complete Response rate(pCR)
Pathological Complete Response (pCR) rate: It refers to the absence of any invasive cancer in the resected specimens (breast + axilla) after completion of neoadjuvant chemotherapy and surgery (i.e., ypT0/is, ypN0).
Time frame: through study completion, an average of 1 year
Objective response rate (ORR)
Objective response rate (ORR) based on RECIST v1.1 assessment, defined as the number of target lesion responders evaluated by MRI/ultrasound;
Time frame: up to 24 weeks
Event-Free Survival (EFS)
EFS is defined as the time from randomization to any of the following events: disease progression, local or remote recurrence, second primary malignant tumor (breast cancer or other cancers) or death caused by any reason during neoadjuvant treatment;
Time frame: 5 years after surgery
Disease free survival (DFS)
DFS is defined as the time from surgery to any of the following events: local or distant recurrence, or death for any reason;
Time frame: 5 years after surgery
Disease free survival (DDFS)
The time from surgery to distant recurrence or death for any reason;
Time frame: 5 years after surgery
Incidence of treatment-emergent adverse events
Evaluate the nature, incidence, and severity of adverse events according to CTCAE 5.0.
Time frame: After each cycle of chemotherapy (21 days as 1 cycle)]
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