TNBC - Triple-Negative Breast Cancer
Conditions
Keywords
PD1, TNBC, Neoadjuvant chemotherapy
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.
Interventions
DRUGToripalimab
Toripalimab 240mg every cycle
DRUGPCb-EC
Albumin Paclitaxel + Carboplatin\*4 Followed by Epirubicin + Cyclophosphamide\*4
DRUGPCb
Albumin Paclitaxel + Carboplatin \*6
Sponsors
Henan Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response (pCR) rates | Up to 180 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival (EFS) | up to 5 years | — |
| Invasive Disease-Free Survival (IDFS) | up to 5 years | — |
| Overall Survival (OS) | up to 5 years | — |
| Objective response rate（ORR） | up to 180 days | — |
| EORTC QLQ-C30 questionnaire | up to 18 months | All of the scales and single-item measures range in score from 0 to 100. A high scale scorerepresents a higher response level |
| EORTC QLQ-BR23 questionnaire | up to 18 months | 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, |
| Adverse events | up to 18 months | — |
Contacts
Primary ContactZhenzhen Liu
Outcome results
None listed