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

NCT ID: NCT07256964

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-26
• Study Completion Date: 2033-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PCb-EC+PD1

Group Type: ACTIVE_COMPARATOR

Toripalimab

Intervention Type: DRUG

Toripalimab 240mg every cycle

PCb-EC

Intervention Type: DRUG

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

PCb+PD1

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: DRUG

Toripalimab 240mg every cycle

PCb

Intervention Type: DRUG

Albumin Paclitaxel + Carboplatin \*6

Interventions

Toripalimab

Toripalimab 240mg every cycle

Intervention Type: DRUG

PCb-EC

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

Intervention Type: DRUG

PCb

Albumin Paclitaxel + Carboplatin \*6

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zhenzhen Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zhenzhen Liu

Role: CONTACT

zlyyliuzhenzhen0800@zzu.edu.cn

+8613603862755

Other Identifiers

HELEN-TRIO-TORI

Identifier Type: -

Identifier Source: org_study_id