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

November 19, 2025 updated by: Kazuki Nozawa, Nagoya City University

Sustainable and Efficient Platform of New Therapeutic Development for Early Breast Cancer (S-FACT)

Randomized phase II trial targeting early-stage breast cancer (stage II-III) applicable to preoperative chemotherapy (NAC), comparing standard treatment with multiple experimental treatments.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8601
        • Recruiting
        • Nagoya City University
        • Contact:
        • Principal Investigator:
          • Kazuki Nozawa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: JCOG2205-TN
KEYNOTE-522 regimen: Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab
Drug: TN
Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab
Experimental: JCOG2205-TN-1
Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab
Drug: TN-1
Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab Niraparib Pembrolizumab AC
Other Names:
  • KEYNOTE-522 regimen

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nagoya City University

Collaborators

Japan Clinical Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2040

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 2, 2024

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JCOG2205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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