Status:
RECRUITING
Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer
Lead Sponsor:
Nagoya City University
Collaborating Sponsors:
Japan Clinical Oncology Group
Conditions:
Breast Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 adap...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed invasive breast carcinoma
- Stage II or III
- ECOG performance status of 0 or 1
- Age 18-80
Exclusion
- 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).
Key Trial Info
Start Date :
July 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2040
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06535893
Start Date
July 30 2024
End Date
June 30 2040
Last Update
November 20 2025
Active Locations (1)
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1
Nagoya City University
Nagoya, Aichi-ken, Japan, 467-8601