The objective of this study is to evaluate the efficacy and safety of chemotherapy plus toripalimab, with or without JS004,as neoadjuvant therapy for patients with triple-negative breast cancer (TNBC). TNBC patients were randomly assigned in a 2:2:1 ratio to receive either JS004 plus toripalimab plus chemotherapy, toripalimab plus chemotherapy, or chemotherapy alone.Surgery will be performed within 5 weeks after the last dose of neoadjuvant treatment.
Subjects must voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up visits.
Age ≥ 18 years.
ECOG score ≤ 1.
Newly diagnosed, non-metastatic breast cancer of stage II-III, confirmed by histopathology or cytopathology (T1c-2 cN1-2 (≥2cm) or T3-4 cN0-2).
Prior exposure to drugs targeting the same therapeutic target as the study treatment drug planned for administration.
Radiotherapy, chemotherapy, surgery, or other targeted immunotherapy for triple-negative breast cancer before enrollment.
Uncontrolled central nervous system metastases (symptomatic or requiring glucocorticoids or mannitol for symptom control).
Inflammatory breast cancer, bilateral breast cancer, or occult breast cancer.
Parallel
JS004 in combination with toripalimab and chemotherapy
DrugBTLA inhibitor (JS004):200mg, IV infusion , d1, Q3W;(1-24 week) Toripalimab:240mg, IV infusion , d1, Q3W;(1-24 week) Carboplatin: IV infusion,AUC=5, d1,q3w(OR AUC=1.5,d1,qw);(1-12 week) Paclitaxel:IV infusion,80 mg/m2,qw;(1-12 week) Doxorubicin:IV infusion,60 mg/m2,q3w(OR Epirubicin:IV infusion,90 mg/m2,q3w);(13-24 week) Cyclophosphamide:IV infusion,600 mg/m2,q3w(13-24 week)
Toripalimab and chemotherapy
DrugToripalimab:240mg, IV infusion , d1, Q3W;(1-24 week) Carboplatin: IV infusion,AUC=5, d1,q3w(OR AUC=1.5,d1,qw);(1-12 week) Paclitaxel:IV infusion,80 mg/m2,qw;(1-12 week) Doxorubicin:IV infusion,60 mg/m2,q3w(OR Epirubicin:IV infusion,90 mg/m2,q3w);(13-24 week) Cyclophosphamide:IV infusion,600 mg/m2,q3w(13-24 week)
Chemotherapy
DrugCarboplatin: IV infusion,AUC=5, d1,q3w(OR AUC=1.5,d1,qw);(1-12 week) Paclitaxel:IV infusion,80 mg/m2,qw;(1-12 week) Doxorubicin:IV infusion,60 mg/m2,q3w(OR Epirubicin:IV infusion,90 mg/m2,q3w);(13-24 week) Cyclophosphamide:IV infusion,600 mg/m2,q3w(13-24 week)
Pathologic complete response (pCR) rate
PCR rate is defined as the proportion of participants who have achieved pathologic complete response (on routine hematoxylin and eosin staining, no tumor cell can be found in tumor bed or lymph node) in all participants.
Objective response rate (ORR)
ORR is defined according to the RECIST v1.1 criteria.
Breast pathologic complete response (bpCR)
The bpCR is defined as the histological evidence of no malignancy in the primary lesion of breast cancer, or only carcinoma in situ (i.e., ypT0/Tis, in accordance with current AJCC staging system).
Residual Cancer Burden (RCB) 0-1
Rate of RCB 0-1 at time of surgery
Event-free Survival (EFS)
Event free survival (EFS) is defined as the time from randomization to first EFS event. For subjects who had breast cancer surgery, EFS events were post-surgery breast cancer relapse, second primary malignancy or death without recurrence. For subjects who did not have breast cancer surgery, EFS events were death during clinical follow-up or non-completion of any neoadjuvant investigational product due to disease progression
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