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

A Single-Arm Phase II Trial of Neoadjuvant Toripalimab, Docetaxel, Plus Carboplatin in Patients With Localized Triple-Negative Breast Cancer

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Triple Negative Breast Cancer
• Intervention / Treatment: Drug: Toripalimab; Drug: Carboplatin; Drug: Docetaxel

Detailed Description

Neoadjuvant chemotherapy combined with immunotherapy is the recommended therapeutic approach for patients with localized triple-negative breast cancer (TNBC). The combination regimen improved the pCR rate of triple negative breast cancer, but its side effects also increased. In the KEYNOTE-522 trial, 78% of patients receiving pembrolizumab combined with anthracycline and paclitaxel chemotherapy experienced grade 3 or higher adverse reactions, while the incidence of grade 3 or higher adverse events for patients receiving tislelizumab plus nab-paclitaxel and carboplatin in the CTRIO study was 53.2%. Toripalimab (an anti PD-1 monoclonal) combined with paclitaxel (albumin binding type) for first-line treatment of recurrent or metastatic TNBC was recently approved based on the results from the TORCHLIGHT study. This study aims to investigate efficacy and safety of neoadjuvant toripalimab plus docetaxel and carboplatin in patients with localized TNBC.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neoadjuvant TCb+Toripalimab; Patients receive toripalimab (240 mg) plus docetaxel and carboplatin (AUC=4) on day 1 of each 21-day cycle for 6 cycles.	Drug: Toripalimab; Toripalimab was given 240 mg intravenously on day 1 of each 21-day cycle for 6 cycles.; Drug: 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.; Drug: Docetaxel; Docetaxel was administered at a dose of 75 mg/m2 on day 1 of each 21-day cycle for 6 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Residual Cancer Burden (RCB) of 0-1	The number of patients with RCB of 0-1 after neoadjuvant therapy and surgery.	1 year
Objective Response Rate (ORR)	The number of patients with complete response and partial response out of the total number of participants.	1 year
Event-Free Survival (EFS)	EFS was defined as the time from registration to disease progression (local relapse or distant metastases) or death from any cause, whichever came first.	3 years after the last patient is enrolled
Safety of the combination therapy	Adverse events (AEs) were graded according to NCI CTCAE v5.0.	1 year

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Jun Tang, MD, Sun Yat-sen University Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: TNBC, neoadjuvant, immunotherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel; Carboplatin; toripalimab
• Other Study ID Numbers: NeoTOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol and Statistical Analysis Plan (SAP) will be shared with other researchers after publication of the study.
• IPD Sharing Time Frame: Study Protocol and Statistical Analysis Plan (SAP) will be shared with other researchers after publication of the study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No