Not yet recruiting NCT07256964
Toripalimab Combined With Anthracycline-free or Anthracycline-containing Chemotherapy as Neoadjuvant Chemotherapy for Early Triple Negative Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Toripalimab, PCb-EC, PCb.
- Who it may be relevant to
- Registry conditions: TNBC - Triple-Negative Breast Cancer. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Toripalimab
Toripalimab 240mg every cycle - Drug PCb-EC
Albumin Paclitaxel + Carboplatin\*4 Followed by Epirubicin + Cyclophosphamide\*4 - Drug PCb
Albumin Paclitaxel + Carboplatin \*6
Primary outcome measures
- Pathologic complete response (pCR) rates [Time frame: Up to 180 days]
Secondary outcome measures (7)
- Objective response rate（ORR） [Time frame: up to 180 days]
- Event-free survival (EFS) [Time frame: up to 5 years]
- Invasive Disease-Free Survival (IDFS) [Time frame: up to 5 years]
- Overall Survival (OS) [Time frame: up to 5 years]
- Adverse events [Time frame: up to 18 months]
- EORTC QLQ-C30 questionnaire [Time frame: up to 18 months]
- EORTC QLQ-BR23 questionnaire [Time frame: up to 18 months]
Eligibility criteria
Inclusion criteria
- 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.
- Pregnancy Status: For women of childbearing potential, a negative serum pregnancy test within 14 days prior to randomization.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1.
- Informed Consent: Signed informed consent obtained.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07256964 · HELEN-TRIO-TORI