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

A Prospective, Randomized Controlled, Multicenter Phase II Clinical Study of Toripalimab Combined With PCb-EC Regimen (Albumin Paclitaxel + Carboplatin Followed by Epirubicin + Cyclophosphamide) or PCb Regimen (Albumin Paclitaxel + Carboplatin) as Neoadjuvant Therapy for Triple-Negative Breast Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: TNBC - Triple-Negative Breast Cancer
• Intervention / Treatment: Drug: Toripalimab; Drug: PCb-EC; Drug: PCb

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhenzhen Liu; Phone Number: +8613603862755; Email: zlyyliuzhenzhen0800@zzu.edu.cn

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age: 18-70 years.
2. Disease Status: Clinical pathological confirmation of cT2-cT4d, or cT1c with axillary lymph node metastasis.
3. Pathology: Histopathologically confirmed triple-negative, invasive breast carcinoma.
4. Definition of Triple-Negative Breast Cancer:
5. ER and PR negative (IHC nuclear staining <10%).
6. Her-2 negative (IHC 0 or 1+ without FISH, or IHC 2+ with FISH demonstrating no amplification).
7. Measurable Disease: Presence of clinically measurable lesion(s) confirmed by ultrasound, mammography, or optional MRI within 1 month prior to randomization.
8. Adequate Organ and Bone Marrow Function (within 1 month prior to chemotherapy), indicating no contraindications for chemotherapy:
9. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L
10. Hemoglobin (Hb) ≥ 90 g/L
11. Platelet count (PLT) ≥ 100 × 10⁹/L
12. Total Bilirubin (TBIL) < 1.5 × ULN (Upper Limit of Normal)
13. Serum Creatinine (Cr) < 1.5 × ULN
14. Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) < 1.5 × ULN
15. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 50% as measured by echocardiogram.
16. Pregnancy Status: For women of childbearing potential, a negative serum pregnancy test within 14 days prior to randomization.
17. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1.
18. Informed Consent: Signed informed consent obtained.

Exclusion Criteria:

1. 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).
2. Prior Anti-Cancer Therapy: Any prior chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for the current breast cancer.
3. Second Primary Malignancy: Presence of a second primary malignancy, except for:
4. Adequately treated non-melanoma skin carcinoma.
5. Prior Immunotherapy: Previous treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or any other immunomodulatory therapy.
6. Immunodeficiency or Autoimmune Disease: Diagnosed immunodeficiency or active autoimmune disease requiring systemic treatment.
7. Severe Comorbidities: Severe or uncontrolled pulmonary or cardiac disease.
8. Active Hepatitis: Active Hepatitis B or Hepatitis C infection.
9. Transplantation History: History of solid organ or bone marrow transplantation.
10. Pregnancy/Lactation: Pregnant or lactating women.
11. Other Medical Conditions: Any other severe, uncontrolled medical condition that, in the investigator's judgment, constitutes a contraindication to chemotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PCb-EC+PD1	Drug: Toripalimab; Toripalimab 240mg every cycle; Drug: PCb-EC; Albumin Paclitaxel + Carboplatin*4 Followed by Epirubicin + Cyclophosphamide*4
Experimental: PCb+PD1	Drug: Toripalimab; Toripalimab 240mg every cycle; Drug: PCb; Albumin Paclitaxel + Carboplatin *6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pathologic complete response (pCR) rates	Up to 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)		up to 5 years
Event-free survival (EFS)		up to 5 years
Objective response rate（ORR）		up to 180 days
Invasive Disease-Free Survival (IDFS)		up to 5 years
Adverse events		up to 18 months
EORTC QLQ-C30 questionnaire	All of the scales and single-item measures range in score from 0 to 100. A high scale scorerepresents a higher response level	up to 18 months
EORTC QLQ-BR23 questionnaire	All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning,	up to 18 months

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 26, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2033

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: TNBC; PD1; Neoadjuvant chemotherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Skin and Connective Tissue Diseases; Triple Negative Breast Neoplasms; toripalimab
• Other Study ID Numbers: HELEN-TRIO-TORI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that underlie the results of the study will be made avaliable after de-indentification.
• IPD Sharing Time Frame: Within 18 months after the publication of the results.
• IPD Sharing Access Criteria: Researchers can gain access to the data from the corresponding author upon written request with detailed study plan.

Drug and device information, study documents

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