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Clinical Trials in Japan / NCT06535893
Recruiting Phase 2

Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer

NCT06535893 · tracked via the Priya Life Science Japan tracker
Sponsor
Nagoya City University
Phase
Phase 2
Started
2024-07-30
Last updated
2025-11-20

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

TNTN-1

TN: Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab

TN-1: Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab Niraparib Pembrolizumab AC

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • pathological complete response (pCR) — Baseline to surgery
    pCR is defined as the absence of invasive cancer in the breast and sampled regional lymph nodes.
  • ctDNA clearance rate — Before Neoadjuvant chemotherapy to surgery
    ctDNA test was performed by Natera

Trial sites (1)

FacilityCityRegionStatus
Nagoya City University Nagoya Aichi-ken Recruiting

More Nagoya City University trials in Japan

Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer Recruiting
Personalized Detection of ctDNA for Patients With HER2-Positive Metastatic Breast Cancer Patients Who Achieved Durable Response to Anti-HER2 Treatment Active, not recruiting
Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early Breast Cancer Starting soon
The Real-world Treatment Satisfaction by Gefapixiant in RCC Recruiting

Other trials for the same condition

Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer Recruiting
PALbociclib CoLlaborative Adjuvant Study Active, not recruiting
A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH) Recruiting
Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 Recruiting
Evaluating the Response-Guided Therapy With Neoadjuvant Endocrine Therapy to Optimize Adjuvant Treatment in Premenopausal HR+/HER2- Breast Cancer (JCOG2402, Young HOPE) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06535893 on ClinicalTrials.gov ↗ ← All trials in Japan