NCT06535893 Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer
| NCT ID | NCT06535893 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Nagoya City University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-07-30 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-07-30 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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).
Frequently Asked Questions
Who can join the NCT06535893 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06535893 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06535893 currently recruiting?
Yes, NCT06535893 is actively recruiting participants. Visit ClinicalTrials.gov or contact Nagoya City University to inquire about joining.
Where is the NCT06535893 trial being conducted?
This trial is being conducted at Nagoya, Japan.
Who is sponsoring the NCT06535893 clinical trial?
NCT06535893 is sponsored by Nagoya City University. The trial plans to enroll 100 participants.
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