RecruitingPhase 2NCT06535893

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)

Sponsor

Nagoya City University

Enrollment

100 participants

Start Date

Jul 30, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

Histologically or cytologically confirmed invasive breast carcinoma
Stage II or III
ECOG performance status of 0 or 1
Age 18-80

Exclusion Criteria4

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).