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Clinical Trials in China / NCT06618014
Active, not recruiting Phase 2

Neoadjuvant Toripalimab Plus Docetaxel and Carboplatin in Patients With Localized TNBC (NeoTOP)

NCT06618014 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 2
Started
2022-01-11
Last updated
2026-05-15

Condition(s) studied

Breast CancerTriple Negative Breast Cancer

Investigational drug(s) / intervention(s)

ToripalimabDocetaxelCarboplatin

Toripalimab: Toripalimab was given 240 mg intravenously on day 1 of each 21-day cycle for 6 cycles.

Docetaxel: Docetaxel was administered at a dose of 75 mg/m2 on day 1 of each 21-day cycle for 6 cycles.

Carboplatin: Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 4 on day 1 of each 21-day cycle for 6 cycles.

Study summary

This study aims to investigate efficacy and safety of neoadjuvant toripalimab plus docetaxel and carboplatin in patients with localized triple-negative breast cancer.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
69 Years
Healthy volunteers
No
Inclusion Criteria: * Pathologically confirmed TNBC. ER and PR negatives are defined as \< 10% of cells expressing hormone receptors by IHC analysis. HER2 negative is defined as IHC 0 or 1+, or ISH-negative. * Treatment-naive clinical stage T1-4N1-N3 or T2-4N0 localized TNBC. * Female patients aged ≥18 years, \< 70 years. * Able to comply with the required protocol and follow-up procedures. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Life expectancy ≥12 weeks. * Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥90 x 109/L, and Hemoglobin ≥90 g/L (may be transfused to maintain or exceed this level). * Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 1.5 x ULN. * Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 50 ml/min. * Subjects should not be pregnant or breast-feeding. Exclusion Criteria: * Inflammatory breast cancer or stage IV breast cancer. * Prior systemic antitumor treatment for any malignancy, including chemotherapy, radiotherapy, immunotherapy and targeted therapy. * History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted. * Inability to comply with protocol or study procedures. * Subjects with active, known or suspected autoimmune disease. Subjects in conditions not expected to recur in the absence of an external trigger, or not requiring systemic treatment are permitted to enroll. * Previous history of interstitial lung disease/pneumonia. * Patient who has had an allogeneic tissue/solid organ transplant. * A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study. * A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease. * Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). * Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over) * Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). * Women who are pregnant or nursing.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06618014 on ClinicalTrials.gov ↗ ← All trials in China