Clinical trial · Interventional
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)
NCT06535893CI-TRIAL-00097565recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TN | Drug | — | UNRESOLVED |
| TN-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- JCOG2205-TN
- description
- KEYNOTE-522 regimen: Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab
- interventionNames
- Drug: TN
- type
- EXPERIMENTAL
- label
- JCOG2205-TN-1
- description
- Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab
- interventionNames
- Drug: TN-1
Primary outcomes (2)
- measure
- pathological complete response (pCR)
- timeFrame
- Baseline to surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed invasive breast carcinoma 2. Stage II or III 3. ECOG performance status of 0 or 1 4. Age 18-80 Exclusion Criteria: 1. Continuous systemic administration (oral or intravenous) of steroid drugs or other immunosuppressants. 2. History or complication of interstitial lung disease or pulmonary fibrosis diagnosed by imaging or clinical findings. 3. Infection requiring systemic treatment. 4. Active double cancer (however, the following are not excluded: (1) Completely resected cancers: basal cell carcinoma, squamous cell carcinoma at clinical stage I, carcinoma in situ, mucosal carcinoma, superficial bladder carcinoma, (2) Gastrointestinal cancer that has been curatively resected by ESD or EMR, (3) Other cancers that have not recurred for more than 5 years).
References
Publications (0)
Data not yet available
No reference posted for this study.