Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TN, TN-1.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Sustainable and Efficient Platform of New Therapeutic Development for Early Breast Cancer (S-FACT)
Overview
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.
Interventions
- Drug TN
Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab - Drug TN-1
Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab Niraparib Pembrolizumab AC
Primary outcome measures
- pathological complete response (pCR) [Time frame: Baseline to surgery]
- ctDNA clearance rate [Time frame: Before Neoadjuvant chemotherapy to surgery]
Eligibility criteria
Inclusion criteria
- Histologically or cytologically confirmed invasive breast carcinoma
- Stage II or III
- ECOG performance status of 0 or 1
- Age 18-80
Exclusion criteria
- Continuous systemic administration (oral or intravenous) of steroid drugs or other immunosuppressants.
- History or complication of interstitial lung disease or pulmonary fibrosis diagnosed by imaging or clinical findings.
- Infection requiring systemic treatment.
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 1 center
- Nagoya City University — Nagoya
Identifiers
NCT: NCT06535893 · JCOG2205