Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Jul 2024
Longer than P75 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2024
CompletedStudy Start
First participant enrolled
July 30, 2024
CompletedFirst Posted
Study publicly available on registry
August 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2040
November 20, 2025
November 1, 2025
2.9 years
July 30, 2024
November 19, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
pathological complete response (pCR)
pCR is defined as the absence of invasive cancer in the breast and sampled regional lymph nodes.
Baseline to surgery
ctDNA clearance rate
ctDNA test was performed by Natera
Before Neoadjuvant chemotherapy to surgery
Study Arms (2)
JCOG2205-TN
ACTIVE COMPARATORKEYNOTE-522 regimen: Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab
JCOG2205-TN-1
EXPERIMENTALCarboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed invasive breast carcinoma
- Stage II or III
- ECOG performance status of 0 or 1
- Age 18-80
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nagoya City Universitylead
- Japan Clinical Oncology Groupcollaborator
Study Sites (1)
Nagoya City University
Nagoya, Aichi-ken, 467-8601, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 30, 2024
First Posted
August 2, 2024
Study Start
July 30, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2040
Last Updated
November 20, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share