Toripalimab Combined With Anthracycline-free or Anthracycline-containing Chemotherapy as Neoadjuv… (NCT07256964) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Toripalimab Combined With Anthracycline-free or Anthracycline-containing Chemotherapy as Neoadjuvant Chemotherapy for Early Triple Negative Breast Cancer
216 participantsStarted 2025-11-26
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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:
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: