Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer
NCT06535893 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-11-20
Summary
Randomized phase II trial targeting early-stage breast cancer (stage II-III) applicable to preoperative chemotherapy (NAC), comparing standard treatment with multiple experimental treatments.
Conditions
Interventions
- DRUG
-
TN
Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab
- DRUG
-
TN-1
Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab Niraparib Pembrolizumab AC
Sponsors & Collaborators
-
Japan Clinical Oncology Group
collaborator OTHER -
Nagoya City University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-30
- Primary Completion
- 2027-06-30
- Completion
- 2040-06-30
Countries
- Japan
Study Locations
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