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

Phase 2

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: TN; Drug: TN-1

• Registration Number: NCT06535893
• Lead Sponsor: Nagoya City University

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 adaptive design, allowing new treatments to be added during or after the trial. Patients are classified by subtype and randomized between standard and experimental treatments.

The trial is flexible, permitting single or combination new drug therapies and incorporating circulating tumor DNA (ctDNA) evaluation for precise efficacy and prognosis prediction.

Study Timeline

• Study Start: 2024-06-24
• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-07-30
• Study First Posted: 2024-08-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2027-06-30
• Study Completion: 2040-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JCOG2205-TN	TN	KEYNOTE-522 regimen: Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab
JCOG2205-TN-1	TN-1	Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab

Primary Outcome Measures

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

Trial Locations

Locations (1)

Nagoya City University; 🇯🇵 Nagoya, Aichi, Japan