New treatments for early-stage breast cancer
Sustainable and Efficient Platform of New Therapeutic Development for Early Breast Cancer (S-FACT)
This study is testing new pre-surgery chemotherapy options for people with early-stage breast cancer to see if they work better than the standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nagoya City University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nagoya, Aichi-ken) |
| Trial ID | NCT06535893 on ClinicalTrials.gov |
What this trial studies
This phase II trial focuses on early-stage breast cancer (stage II-III) and evaluates the effectiveness of preoperative chemotherapy by comparing standard treatment with multiple experimental therapies. Utilizing an adaptive design, the trial allows for the addition of new treatments during or after the study, enhancing flexibility. Patients are categorized by subtype and randomized to receive either standard or experimental treatments, with the incorporation of circulating tumor DNA (ctDNA) analysis for better efficacy and prognosis predictions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with histologically confirmed invasive breast carcinoma at stage II or III and an ECOG performance status of 0 or 1.
Not a fit: Patients with active double cancer or those requiring systemic treatment for infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to more effective treatment options for patients with early-stage breast cancer.
How similar studies have performed: Other studies have shown promise with adaptive trial designs in oncology, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Nagoya, Aichi-ken
- Nagoya City University — Nagoya, Aichi-ken, Japan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.