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

NCT06618014 | Active Not Recruiting Phase 2

• 1 other identifier: NeoTOP
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Triple Negative Breast Cancer

Keywords

TNBC, neoadjuvant, immunotherapy

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate

  The number of patients with pCR out of the total number of participants using a definition of ypT0/Tis ypN0 after neoadjuvant therapy and surgery.

  1 week after surgery

Secondary Outcomes (4)

• Rate of Residual Cancer Burden (RCB) of 0-1

  1 year

• Objective Response Rate (ORR)

  1 year

• Event-Free Survival (EFS)

  3 years after the last patient is enrolled

• Safety of the combination therapy

  1 year

Study Arms (1)

Neoadjuvant TCb+Toripalimab

EXPERIMENTAL

Patients receive toripalimab (240 mg) plus docetaxel and carboplatin (AUC=4) on day 1 of each 21-day cycle for 6 cycles.

Drug: Toripalimab; Drug: Docetaxel; Drug: Carboplatin

Interventions

Toripalimab DRUG

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

Neoadjuvant TCb+Toripalimab

Docetaxel DRUG

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

Neoadjuvant TCb+Toripalimab

Carboplatin DRUG

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.

Neoadjuvant TCb+Toripalimab

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

toripalimab; Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Jun Tang, MD

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: January 11, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study Protocol and Statistical Analysis Plan (SAP) will be shared with other researchers after publication of the study.

Locations

CN (1)