Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNagoya City University
About this trial
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 criteria
Qualifiers
Histologically or cytologically confirmed invasive breast carcinoma
Stage II or III
ECOG performance status of 0 or 1
Age 18-80
Disqualifiers
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).
Trial design
Treatments tested in this trial
- TN
- TN-1
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Nagoya City University
Lead sponsor
Japan Clinical Oncology Group
Collaborator
Source ClinicalTrials.gov