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

NCT ID: NCT06535893

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-30
• Study Completion Date: 2040-06-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JCOG2205-TN

KEYNOTE-522 regimen: Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab

Group Type: ACTIVE_COMPARATOR

TN

Intervention Type: DRUG

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

JCOG2205-TN-1

Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab

Group Type: EXPERIMENTAL

TN-1

Intervention Type: DRUG

Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab Niraparib Pembrolizumab AC

Interventions

TN

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

Intervention Type: DRUG

TN-1

Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab Niraparib Pembrolizumab AC

Intervention Type: DRUG

Other Intervention Names

KEYNOTE-522 regimen

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Japan Clinical Oncology Group

OTHER

Sponsor Role: collaborator

Nagoya City University

OTHER

Sponsor Role: lead

Responsible Party

Kazuki Nozawa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nagoya City University

Nagoya, Aichi-ken, Japan

Site Status: RECRUITING

Countries

Japan

Facility Contacts

Kazuki Nozawa, MD

Role: primary

k.nozawa@med.nagoya-cu.ac.jp

052-853-8628

Other Identifiers

JCOG2205

Identifier Type: -

Identifier Source: org_study_id