Toripalimab Combined With Anthracycline-free or Anthracycline-containing Chemotherapy as Neoadjuvant Chemotherapy for Early Triple Negative Breast Cancer

NCT07256964 | Not Yet Recruiting Phase 2

• 1 other identifier: HELEN-TRIO-TORI
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the efficacy and safety of a PD-1 inhibitor combined with different chemotherapy regimens (PCb-EC and PCb), in order to develop a superior and well-tolerated neoadjuvant therapeutic strategy for patients with triple-negative breast cancer.

Conditions

TNBC - Triple-Negative Breast Cancer

Keywords

PD1; TNBC; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response (pCR) rates

  Up to 180 days

Secondary Outcomes (7)

• Objective response rate（ORR）

  up to 180 days

• Event-free survival (EFS)

  up to 5 years

• Invasive Disease-Free Survival (IDFS)

  up to 5 years

• Overall Survival (OS)

  up to 5 years

• Adverse events

  up to 18 months

Study Arms (2)

PCb-EC+PD1

ACTIVE COMPARATOR

Drug: Toripalimab; Drug: PCb-EC

PCb+PD1

EXPERIMENTAL

Drug: Toripalimab; Drug: PCb

Interventions

Toripalimab DRUG

Toripalimab 240mg every cycle

PCb+PD1; PCb-EC+PD1

PCb-EC DRUG

Albumin Paclitaxel + Carboplatin\*4 Followed by Epirubicin + Cyclophosphamide\*4

PCb-EC+PD1

PCb DRUG

Albumin Paclitaxel + Carboplatin \*6

PCb+PD1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 years.
• Disease Status: Clinical pathological confirmation of cT2-cT4d, or cT1c with axillary lymph node metastasis.
• Pathology: Histopathologically confirmed triple-negative, invasive breast carcinoma.
• Definition of Triple-Negative Breast Cancer:
• ER and PR negative (IHC nuclear staining \<10%).
• Her-2 negative (IHC 0 or 1+ without FISH, or IHC 2+ with FISH demonstrating no amplification).
• Measurable Disease: Presence of clinically measurable lesion(s) confirmed by ultrasound, mammography, or optional MRI within 1 month prior to randomization.
• Adequate Organ and Bone Marrow Function (within 1 month prior to chemotherapy), indicating no contraindications for chemotherapy:
• Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L
• Hemoglobin (Hb) ≥ 90 g/L
• Platelet count (PLT) ≥ 100 × 10⁹/L
• Total Bilirubin (TBIL) \< 1.5 × ULN (Upper Limit of Normal)
• Serum Creatinine (Cr) \< 1.5 × ULN
• Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) \< 1.5 × ULN
• Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 50% as measured by echocardiogram.

You may not qualify if:

• Metastatic Disease: Evidence of metastatic breast cancer. (To exclude metastasis, CT scans of the chest and abdomen, and a bone scan must be performed at any time point from diagnosis to randomization; PET/CT may serve as an alternative imaging modality).
• Prior Anti-Cancer Therapy: Any prior chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for the current breast cancer.
• Second Primary Malignancy: Presence of a second primary malignancy, except for:
• Adequately treated non-melanoma skin carcinoma.
• Prior Immunotherapy: Previous treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or any other immunomodulatory therapy.
• Immunodeficiency or Autoimmune Disease: Diagnosed immunodeficiency or active autoimmune disease requiring systemic treatment.
• Severe Comorbidities: Severe or uncontrolled pulmonary or cardiac disease.
• Active Hepatitis: Active Hepatitis B or Hepatitis C infection.
• Transplantation History: History of solid organ or bone marrow transplantation.
• Pregnancy/Lactation: Pregnant or lactating women.
• Other Medical Conditions: Any other severe, uncontrolled medical condition that, in the investigator's judgment, constitutes a contraindication to chemotherapy.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

toripalimab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhenzhen Liu

CONTACT

+8613603862755; zlyyliuzhenzhen0800@zzu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 2, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2033
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 18 months after the publication of the results.
• Access Criteria: Researchers can gain access to the data from the corresponding author upon written request with detailed study plan.