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Nab-P+Cb+PD1 Inhibitors as Neoadjuvant Therapy for Early TNBC

StatusRecruiting
PhasePhase 2
Started2024-11-06
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 5, 2025 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-11-30
minor
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Eligibility v1
Primary completion date2025-11-06→2026-05-31
Completion date2025-11-06→2026-05-31
Study arms4→2
Interventions6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 ( d 1)+5*Bevacizumab ( d 1) (Drug), 6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1) (Drug), 6*Nab-P (d 1,8,15)+6*Cb (…→6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1) (Drug), 6*Nab-P (d 1,8,15)+6*Cb ( d 1)+6*PD1 (d 1) (Drug)
Eligibility criteria-1,399 characters
[...] er limit of normal) Creatinine<1.5 × ULN AST/ALT < 1.5×ULN; Urine test: Urine protein<2+; If urine protein is ≥ 2+, the 24-hour urine protein quantification display must show protein ≤ 1g Thyroid stimulating hormone (TSH) ≤ upper limit of normal (U [...] significant bleeding tendencies within the previous month; Urine routine shows that urine protein is ≥ 2+and confirms that 24-hour urine protein quantification is>1g; Suffering from serious cardiovascular and cerebrovascular diseases, including but not limited to those that meet NYHA criteria (Grade III or higher), or myocardial infarction or cerebr [...] [...]
Study description-459 characters
[...] o meet the inclusion criteria will be randomly divided into fourtwo groups (Group A, and Group B,Group C, Group D) at a ratio of 1:1:1:1, and stratified according to T stage and N stage. The ad [...] )+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles; Group C: albumin-bound paclitaxe (260 mg/m²,d 1, 6 cycles)+Carboplatin (AUC=5,d 1, 6 cycles)+Camrelizumab (200 mg, , d 1, 6 cycles)+Bevacizumab (15mg/kg, d 1,5 cycles), 21 days as one cycle; Group D: albumin-bound paclitaxe (125 mg/m²,d 1,8,15,6 cycles)+Carboplatin (AUC=5, d 1, 6 cycles)+Camrelizu [...] Primary endpoint: Pathological complete respon [...] [...]
Study title-39 characters
Nab-P+Cb+PD1 Inhibitors Combined/not Combined with Bevacizumab Asas Neoadjuvant Therapy for Early TNBC
2025-02-05
minor
Original filing
We plan to explore the efficacy and safety of albumin-bound paclitaxel+carboplatin+Camrelizumab in neoadjuvant therapy for early TNBC patients, optimize the administration method and drug combination therapy.
Trial Details
NCT Number NCT06817525
Lead Sponsor Henan Cancer Hospital
Conditions Triple-negative Breast Cancer
Enrollment 64 participants
Start Date 2024-11-06
Primary Completion 2026-05-31 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-05