NCT06535893

Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer

Sustainable and Efficient Platform of New Therapeutic Development for Early Breast Cancer (S-FACT)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Nagoya City University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized phase II trial targets early-stage breast cancer (stage II-III) with preoperative chemotherapy (NAC). It compares standard treatment with multiple experimental treatments using an adaptive design, allowing new treatments to be added during or after the trial. Patients are classified by subtype and randomized between standard and experimental treatments. The trial is flexible, permitting single or combination new drug therapies and incorporating circulating tumor DNA (ctDNA) evaluation for precise efficacy and prognosis prediction.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	TN	Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab
DRUG	TN-1	Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab Niraparib Pembrolizumab AC

Timeline

• Start date: 2024-07-30
• Primary completion: 2027-06-30
• Completion: 2040-06-30
• First posted: 2024-08-02
• Last updated: 2025-11-20

Locations

1 site across 1 country: Japan